ivacaftor 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
cystic fibrosis transmembrane regulator (CFTR) protein modulators, correctors, and amplifiers 4228 873054-44-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • kalydeco
  • VX 770
  • ivacaftor
Ivacaftor is a potentiator of the CFTR protein. The CFTR protein is a chloride channel present at the surface of epithelial cells in multiple organs. Ivacaftor facilitates increased chloride transport by potentiating the channel-open probability (or gating) of the CFTR protein.
  • Molecular weight: 392.50
  • Formula: C24H28N2O3
  • CLOGP: 3.82
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 3
  • TPSA: 78.43
  • ALOGS: -5.29
  • ROTB: 4
  • Status: ONP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.30 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Hosey CM, Chan R, Benet LZ
S (Water solubility) 0.05 mg/mL Bocci G, Oprea TI, Benet LZ

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 4.410 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 4.539 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 0.394 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 5.781 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 0.300 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 0.340 % High 1
herg hERG pIC50 4.848 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 11.535 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 27.290 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 0.330 % High 1
kinase-safety-class ACVR2A,ACVR2B,AKT2,AKT3,ALK,AURKA,AURKB,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK1,CDK5,CDK9,CHEK1,CSF1R,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,GSK3B,IRAK1,ITK,JAK1,JAK2,KIT,MAP3K1,MAP3K10,MAP3K11,MAP3K21,MAP3K7,MAP4K1,MAP4K3,MAPK1,MAPK10,MAPK12,MAPK7,MAPK9,MAPKAPK2,MARK4,MELK,MET,MTOR,NTRK2,PAK4,PDK1,PDK2,PDK4,PDPK1,PIK3CB,PIK3CD,PIM2,PRKCD,PRKDC,SGK1,SIK2,SIK3,STK33,SYK,TEK,TTK,ULK1,ULK2 67
kinase-selectivity-class AXL,BRAF,DDR1,EIF2AK3,GRK2,PDK4 6
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 3.334 High 1
mh-clint Mouse hepatocyte intrinsic clearance 19.724 High 1
mppb Mouse plasma protein binding (% unbound) 0.290 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 3.357 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 0.220 % High 1
rh-clint Rat hepatocyte intrinsic clearance 4.539 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 0.390 % High 1
rppb Rat plasma protein binding (% unbound) 0.210 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 1.936 uM High 1

Approvals:

DateAgencyCompanyOrphan
Aug. 21, 2020 EMA Vertex Pharmaceuticals (Ireland) Limited
Jan. 31, 2012 FDA VERTEX PHARMS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Infective pulmonary exacerbation of cystic fibrosis 1187.55 36.49 217 2853 10062 90615315
Hospitalisation 161.37 36.49 81 2989 128019 90497358
Pulmonary function test decreased 102.78 36.49 25 3045 4469 90620908
Abortion spontaneous 79.29 36.49 38 3032 54018 90571359
Exposure during pregnancy 79.17 36.49 65 3005 238345 90387032
Amniotic fluid index increased 76.43 36.49 11 3059 104 90625273
Haemoptysis 76.31 36.49 32 3038 33288 90592089
Cystic fibrosis respiratory infection suppression 70.90 36.49 12 3058 343 90625034
Foetal macrosomia 67.59 36.49 11 3059 246 90625131
Left-to-right cardiac shunt 59.56 36.49 10 3060 272 90625105
Pelvic kidney 45.59 36.49 7 3063 106 90625271
Infection 44.72 36.49 58 3012 362036 90263341
Distal intestinal obstruction syndrome 40.93 36.49 8 3062 515 90624862
Chalazion 40.22 36.49 8 3062 564 90624813
Suicidal ideation 39.83 36.49 27 3043 73828 90551549
Butterfly rash 39.15 36.49 10 3060 2175 90623202
Oesophageal achalasia 38.98 36.49 8 3062 660 90624717
Pancreatitis 38.78 36.49 26 3044 69800 90555577
Depressed mood 38.67 36.49 23 3047 50199 90575178
Sweat test abnormal 37.68 36.49 5 3065 24 90625353

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Infective pulmonary exacerbation of cystic fibrosis 552.23 36.62 116 1940 7702 42611577
Hospitalisation 145.69 36.62 71 1985 74259 42545020
Forced expiratory volume decreased 60.37 36.62 20 2036 7610 42611669
Cystic fibrosis respiratory infection suppression 56.29 36.62 10 2046 265 42619014
Distal intestinal obstruction syndrome 44.22 36.62 9 2047 498 42618781
Alanine aminotransferase increased 38.99 36.62 33 2023 88373 42530906
Pulmonary function test decreased 37.37 36.62 13 2043 5719 42613560
Product dose omission issue 36.66 36.62 41 2015 154324 42464955

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Infective pulmonary exacerbation of cystic fibrosis 1179.90 32.24 232 3845 14539 110570683
Hospitalisation 152.08 32.24 83 3994 142410 110442812
Cystic fibrosis respiratory infection suppression 92.66 32.24 16 4061 473 110584749
Haemoptysis 91.37 32.24 47 4030 71307 110513915
Pulmonary function test decreased 75.65 32.24 23 4054 8677 110576545
Distal intestinal obstruction syndrome 74.82 32.24 15 4062 1010 110584212
Abortion spontaneous 72.79 32.24 32 4045 34250 110550972
Amniotic fluid index increased 68.68 32.24 10 4067 94 110585128
Forced expiratory volume decreased 66.27 32.24 23 4054 13153 110572069
Hepatic cytolysis 63.99 32.24 34 4043 55019 110530203
Blood alkaline phosphatase increased 61.15 32.24 36 4041 70899 110514323
Alanine aminotransferase increased 61.00 32.24 52 4025 183721 110401501
Exposure during pregnancy 56.84 32.24 48 4029 167376 110417846
Product dose omission issue 54.38 32.24 63 4014 321719 110263503
Foetal macrosomia 53.24 32.24 8 4069 95 110585127
Gamma-glutamyltransferase increased 49.93 32.24 30 4047 61279 110523943
Chalazion 49.72 32.24 10 4067 684 110584538
Sputum increased 49.13 32.24 15 4062 5736 110579486
Left-to-right cardiac shunt 47.89 32.24 8 4069 193 110585029
Suicidal ideation 40.50 32.24 31 4046 93906 110491316
Aspartate aminotransferase increased 38.83 32.24 38 4039 159898 110425324
Vitamin A increased 38.64 32.24 5 4072 17 110585205
Butterfly rash 38.56 32.24 10 4067 2121 110583101
Mood swings 38.02 32.24 18 4059 22794 110562428
Oesophageal achalasia 34.92 32.24 8 4069 1013 110584209
Pneumonia 34.90 32.24 90 3987 876624 109708598
Blood bilirubin increased 34.80 32.24 26 4051 75946 110509276
Sweat test abnormal 34.74 32.24 5 4072 43 110585179
Pancreatitis 34.16 32.24 28 4049 93505 110491717
Behaviour disorder 34.16 32.24 13 4064 9634 110575588
Cough 34.13 32.24 61 4016 461580 110123642
Papilloedema 33.68 32.24 12 4065 7397 110577825
Drug interaction 33.09 32.24 63 4014 500120 110085102
Depressed mood 32.84 32.24 23 4054 60786 110524436

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC R07AX02 RESPIRATORY SYSTEM
OTHER RESPIRATORY SYSTEM PRODUCTS
OTHER RESPIRATORY SYSTEM PRODUCTS
Other respiratory system products
ATC R07AX30 RESPIRATORY SYSTEM
OTHER RESPIRATORY SYSTEM PRODUCTS
OTHER RESPIRATORY SYSTEM PRODUCTS
Other respiratory system products
ATC R07AX31 RESPIRATORY SYSTEM
OTHER RESPIRATORY SYSTEM PRODUCTS
OTHER RESPIRATORY SYSTEM PRODUCTS
Other respiratory system products
ATC R07AX32 RESPIRATORY SYSTEM
OTHER RESPIRATORY SYSTEM PRODUCTS
OTHER RESPIRATORY SYSTEM PRODUCTS
Other respiratory system products
MeSH PA D049990 Membrane Transport Modulators
MeSH PA D065101 Chloride Channel Agonists
FDA MoA N0000184145 Chloride Channel Activation Potentiators
FDA EPC N0000184146 Cystic Fibrosis Transmembrane Conductance Regulator Potentiator
FDA MoA N0000185503 P-Glycoprotein Inhibitors
FDA MoA N0000185504 Cytochrome P450 2C9 Inhibitors
FDA MoA N0000190114 Cytochrome P450 3A Inhibitors
CHEBI has role CHEBI:66902 CFTR potentiator
CHEBI has role CHEBI:71031 orphan drug

Related Drugs by ATC class:

R07AX Other respiratory system products 6 drugs
deutivacaftorelexacaftorlumacaftornitric oxidetezacaftorvanzacaftor

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Cystic fibrosis of the lung indication 86555001




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.08 acidic
pKa2 9.12 acidic
pKa3 11.19 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
150MG KALYDECO VERTEX PHARMS N203188 Jan. 31, 2012 RX TABLET ORAL 8354427 July 6, 2026 METHOD OF TREATING A PATIENT HAVING CYSTIC FIBROSIS, THE PATIENT HAVING A R117H MUTATION IN CFTR, USING N-(5-HYDROXY-2,4-DI-TERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE
150MG KALYDECO VERTEX PHARMS N203188 Jan. 31, 2012 RX TABLET ORAL 8354427 July 6, 2026 METHOD OF TREATING CYSTIC FIBROSIS
13.4MG/PACKET KALYDECO VERTEX PHARMS INC N207925 May 3, 2023 RX GRANULE ORAL 8354427 July 6, 2026 TREATMENT OF CYSTIC FIBROSIS USING IVACAFTOR IN A PATIENT AGE 1 MONTH TO <4 MONTHS WHO HAS A R117H MUTATION IN THE CFTR GENE
25MG/PACKET KALYDECO VERTEX PHARMS INC N207925 April 29, 2019 RX GRANULE ORAL 8354427 July 6, 2026 METHOD OF TREATING A PATIENT HAVING CYSTIC FIBROSIS, THE PATIENT HAVING A R117H MUTATION IN CFTR, USING N-(5-HYDROXY-2,4-DI-TERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE
25MG/PACKET KALYDECO VERTEX PHARMS INC N207925 April 29, 2019 RX GRANULE ORAL 8354427 July 6, 2026 METHOD OF TREATING CYSTIC FIBROSIS
25MG/PACKET KALYDECO VERTEX PHARMS INC N207925 April 29, 2019 RX GRANULE ORAL 8354427 July 6, 2026 TREATMENT OF CYSTIC FIBROSIS USING IVACAFTOR IN A PATIENT AGE 4 MONTHS TO <6 YEARS WHO HAS A R117H MUTATION IN THE CFTR GENE
5.8MG/PACKET KALYDECO VERTEX PHARMS INC N207925 May 3, 2023 RX GRANULE ORAL 8354427 July 6, 2026 TREATMENT OF CYSTIC FIBROSIS USING IVACAFTOR IN A PATIENT AGE 1 MONTH TO <4 MONTHS WHO HAS A R117H MUTATION IN THE CFTR GENE
50MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL 8354427 July 6, 2026 METHOD OF TREATING A PATIENT HAVING CYSTIC FIBROSIS, THE PATIENT HAVING A R117H MUTATION IN CFTR, USING N-(5-HYDROXY-2,4-DI-TERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE
50MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL 8354427 July 6, 2026 METHOD OF TREATING CYSTIC FIBROSIS
50MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL 8354427 July 6, 2026 TREATMENT OF CYSTIC FIBROSIS USING IVACAFTOR IN A PATIENT AGE 6 MONTHS TO <6 YEARS WHO HAS A R117H MUTATION IN THE CFTR GENE
75MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL 8354427 July 6, 2026 METHOD OF TREATING A PATIENT HAVING CYSTIC FIBROSIS, THE PATIENT HAVING A R117H MUTATION IN CFTR, USING N-(5-HYDROXY-2,4-DI-TERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE
75MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL 8354427 July 6, 2026 METHOD OF TREATING CYSTIC FIBROSIS
75MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL 8354427 July 6, 2026 TREATMENT OF CYSTIC FIBROSIS USING IVACAFTOR IN A PATIENT AGE 6 MONTHS TO <6 YEARS WHO HAS A R117H MUTATION IN THE CFTR GENE
150MG;150MG, 100MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 Feb. 12, 2018 RX TABLET ORAL 8354427 July 6, 2026 TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 6 YEARS AND OLDER WHO HAVE A R117H MUTATION IN THE CFTR GENE
75MG;75MG, 50MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 June 21, 2019 RX TABLET ORAL 8354427 July 6, 2026 TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 6 YEARS AND OLDER WHO HAVE A R117H MUTATION IN THE CFTR GENE
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 8354427 July 6, 2026 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE A R117H MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 8354427 July 6, 2026 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A R117H MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 8354427 July 6, 2026 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A R117H MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 8354427 July 6, 2026 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A R117H MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 8354427 July 6, 2026 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A R117H MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
125MG;100MG ORKAMBI VERTEX PHARMS INC N206038 Sept. 28, 2016 RX TABLET ORAL 7973038 Nov. 8, 2026 METHOD OF TREATING CYSTIC FIBROSIS USING N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE AND 3-(6-(1-2,2-DIFLUOROBENZO[D][1,3]DIOXOL-5-YL) CYCLOPROPANECARBOXAMIDO)-3-METHYLPYRIDIN-2-YL)BENZOIC ACID
125MG;100MG ORKAMBI VERTEX PHARMS INC N206038 Sept. 28, 2016 RX TABLET ORAL 8741933 Nov. 8, 2026 METHOD OF TREATING CYSTIC FIBROSIS IN A PATIENT, THE PATIENT HAVING THE F508DEL MUTATION IN CFTR, USING IVACAFTOR AND LUMACAFTOR
125MG;200MG ORKAMBI VERTEX PHARMS INC N206038 July 2, 2015 RX TABLET ORAL 7973038 Nov. 8, 2026 METHOD OF TREATING CYSTIC FIBROSIS USING N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE AND 3-(6-(1-2,2-DIFLUOROBENZO[D][1,3]DIOXOL-5-YL) CYCLOPROPANECARBOXAMIDO)-3-METHYLPYRIDIN-2-YL)BENZOIC ACID
125MG;200MG ORKAMBI VERTEX PHARMS INC N206038 July 2, 2015 RX TABLET ORAL 8741933 Nov. 8, 2026 METHOD OF TREATING CYSTIC FIBROSIS IN A PATIENT, THE PATIENT HAVING THE F508DEL MUTATION IN CFTR, USING IVACAFTOR AND LUMACAFTOR
125MG;200MG ORKAMBI VERTEX PHARMS INC N206038 July 2, 2015 RX TABLET ORAL 8741933 Nov. 8, 2026 METHOD OF TREATING CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE
125MG/PACKET;100MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Aug. 7, 2018 RX GRANULE ORAL 7973038 Nov. 8, 2026 TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND IVACAFTOR
125MG/PACKET;100MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Aug. 7, 2018 RX GRANULE ORAL 8741933 Nov. 8, 2026 TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND IVACAFTOR
188MG/PACKET;150MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Aug. 7, 2018 RX GRANULE ORAL 7973038 Nov. 8, 2026 TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND IVACAFTOR
188MG/PACKET;150MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Aug. 7, 2018 RX GRANULE ORAL 8741933 Nov. 8, 2026 TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND IVACAFTOR
94MG/PACKET;75MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Sept. 2, 2022 RX GRANULE ORAL 7973038 Nov. 8, 2026 TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 1-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND IVACAFTOR
94MG/PACKET;75MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Sept. 2, 2022 RX GRANULE ORAL 8741933 Nov. 8, 2026 TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 1-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND IVACAFTOR
150MG KALYDECO VERTEX PHARMS N203188 Jan. 31, 2012 RX TABLET ORAL 9670163 Dec. 28, 2026 METHOD OF TREATING CYSTIC FIBROSIS
125MG;100MG ORKAMBI VERTEX PHARMS INC N206038 Sept. 28, 2016 RX TABLET ORAL 9670163 Dec. 28, 2026 METHOD OF TREATING A PATIENT HAVING CYSTIC FIBROSIS USING IVACAFTOR AND LUMACAFTOR
125MG;100MG ORKAMBI VERTEX PHARMS INC N206038 Sept. 28, 2016 RX TABLET ORAL 9931334 Dec. 28, 2026 METHOD OF TREATING CYSTIC FIBROSIS IN A PATIENT AGE 6 OR OLDER HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND A SOLID COMPOSITION COMPRISING AMORPHOUS (LESS THAN ABOUT 30% CRYSTALLINE) IVACAFTOR
125MG;200MG ORKAMBI VERTEX PHARMS INC N206038 July 2, 2015 RX TABLET ORAL 9670163 Dec. 28, 2026 METHOD OF TREATING A PATIENT HAVING CYSTIC FIBROSIS USING IVACAFTOR AND LUMACAFTOR
125MG;200MG ORKAMBI VERTEX PHARMS INC N206038 July 2, 2015 RX TABLET ORAL 9931334 Dec. 28, 2026 METHOD OF TREATING CYSTIC FIBROSIS IN A PATIENT AGE 6 OR OLDER HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND A SOLID COMPOSITION COMPRISING AMORPHOUS (LESS THAN ABOUT 30% CRYSTALLINE) IVACAFTOR
13.4MG/PACKET KALYDECO VERTEX PHARMS INC N207925 May 3, 2023 RX GRANULE ORAL 9670163 Dec. 28, 2026 TREATMENT OF CF IN A PATIENT AGE 1 MONTH TO <4 MONTHS WHO HAS AT LEAST ONE CFTR MUTATION RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING A SOLID COMPOSITION COMPRISING AMORPHOUS (LESS THAN ABOUT 30% CRYSTALLINE) IVACAFTOR
25MG/PACKET KALYDECO VERTEX PHARMS INC N207925 April 29, 2019 RX GRANULE ORAL 9670163 Dec. 28, 2026 METHOD OF TREATING CYSTIC FIBROSIS
25MG/PACKET KALYDECO VERTEX PHARMS INC N207925 April 29, 2019 RX GRANULE ORAL 9670163 Dec. 28, 2026 TREATMENT OF CF IN A PATIENT AGE 4 MONTHS TO <6 YEARS WHO HAS ONE CFTR MUTATION RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING A SOLID COMPOSITION COMPRISING AMORPHOUS (LESS THAN ABOUT 30% CRYSTALLINE) IVACAFTOR
5.8MG/PACKET KALYDECO VERTEX PHARMS INC N207925 May 3, 2023 RX GRANULE ORAL 9670163 Dec. 28, 2026 TREATMENT OF CF IN A PATIENT AGE 1 MONTH TO <4 MONTHS WHO HAS AT LEAST ONE CFTR MUTATION RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING A SOLID COMPOSITION COMPRISING AMORPHOUS (LESS THAN ABOUT 30% CRYSTALLINE) IVACAFTOR
50MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL 9670163 Dec. 28, 2026 METHOD OF TREATING CYSTIC FIBROSIS
50MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL 9670163 Dec. 28, 2026 TREATMENT OF CF IN A PATIENT AGE 6 MONTHS TO < 6 YEARS WHO HAS ONE CFTR MUTATION RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING A SOLID COMPOSITION COMPRISING AMORPHOUS (LESS THAN ABOUT 30% CRYSTALLINE) IVACAFTOR
75MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL 9670163 Dec. 28, 2026 METHOD OF TREATING CYSTIC FIBROSIS
75MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL 9670163 Dec. 28, 2026 TREATMENT OF CF IN A PATIENT AGE 6 MONTHS TO < 6 YEARS WHO HAS ONE CFTR MUTATION RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING A SOLID COMPOSITION COMPRISING AMORPHOUS (LESS THAN ABOUT 30% CRYSTALLINE) IVACAFTOR
150MG;150MG, 100MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 Feb. 12, 2018 RX TABLET ORAL 9670163 Dec. 28, 2026 TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVING AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE
150MG;150MG, 100MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 Feb. 12, 2018 RX TABLET ORAL 9931334 Dec. 28, 2026 TREATING CYSTIC FIBROSIS PATIENTS AGES 12 AND OLDER, WHO ARE HOMOZYGOUS FOR F508DEL OR HAVE AT LEAST 1 CFTR GENE MUTATION RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND A SOLID COMPOSITION COMPRISING AMORPHOUS (<30% CRYSTALLINE) IVACAFTOR
150MG;150MG, 100MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 Feb. 12, 2018 RX TABLET ORAL 9931334 Dec. 28, 2026 TREATING CYSTIC FIBROSIS PATIENTS AGES 6 AND OLDER, WHO ARE HOMOZYGOUS FOR F508DEL OR HAVE AT LEAST 1 CFTR GENE MUTATION RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND A SOLID COMPOSITION COMPRISING AMORPHOUS (<30% CRYSTALLINE) IVACAFTOR
75MG;75MG, 50MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 June 21, 2019 RX TABLET ORAL 9670163 Dec. 28, 2026 TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVING AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE
75MG;75MG, 50MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 June 21, 2019 RX TABLET ORAL 9931334 Dec. 28, 2026 TREATING CYSTIC FIBROSIS PATIENTS AGES 12 AND OLDER, WHO ARE HOMOZYGOUS FOR F508DEL OR HAVE AT LEAST 1 CFTR GENE MUTATION RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND A SOLID COMPOSITION COMPRISING AMORPHOUS (<30% CRYSTALLINE) IVACAFTOR
75MG;75MG, 50MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 June 21, 2019 RX TABLET ORAL 9931334 Dec. 28, 2026 TREATING CYSTIC FIBROSIS PATIENTS AGES 6 AND OLDER, WHO ARE HOMOZYGOUS FOR F508DEL OR HAVE AT LEAST 1 CFTR GENE MUTATION RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND A SOLID COMPOSITION COMPRISING AMORPHOUS (<30% CRYSTALLINE) IVACAFTOR
125MG/PACKET;100MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Aug. 7, 2018 RX GRANULE ORAL 9670163 Dec. 28, 2026 TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND A SOLID COMPOSITION COMPRISING AMORPHOUS AND LESS THAN ABOUT 30% CRYSTALLINE IVACAFTOR
125MG/PACKET;100MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Aug. 7, 2018 RX GRANULE ORAL 9931334 Dec. 28, 2026 TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND A SOLID COMPOSITION COMPRISING AMORPHOUS AND LESS THAN ABOUT 30% CRYSTALLINE IVACAFTOR
188MG/PACKET;150MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Aug. 7, 2018 RX GRANULE ORAL 9670163 Dec. 28, 2026 TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND A SOLID COMPOSITION COMPRISING AMORPHOUS AND LESS THAN ABOUT 30% CRYSTALLINE IVACAFTOR
188MG/PACKET;150MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Aug. 7, 2018 RX GRANULE ORAL 9931334 Dec. 28, 2026 TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND A SOLID COMPOSITION COMPRISING AMORPHOUS AND LESS THAN ABOUT 30% CRYSTALLINE IVACAFTOR
94MG/PACKET;75MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Sept. 2, 2022 RX GRANULE ORAL 9670163 Dec. 28, 2026 TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 1-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND A SOLID COMPOSITION COMPRISING AMORPHOUS AND LESS THAN ABOUT 30% CRYSTALLINE IVACAFTOR
94MG/PACKET;75MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Sept. 2, 2022 RX GRANULE ORAL 9931334 Dec. 28, 2026 TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 1-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND A SOLID COMPOSITION COMPRISING AMORPHOUS AND LESS THAN ABOUT 30% CRYSTALLINE IVACAFTOR
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 9670163 Dec. 28, 2026 TREATMENT OF CF IN PATIENTS 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 9670163 Dec. 28, 2026 TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 9670163 Dec. 28, 2026 TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER HAVING IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA USING A SOLID COMPOSITION OF ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 9670163 Dec. 28, 2026 TREATMENT OF CF WITH ELX/TEZ AND A COMP. OF CLAIM 1 OF 9670163 IN CF PATIENTS AGED 6 YEARS AND OLDER WITH AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 9931334 Dec. 28, 2026 TREATMENT OF CF IN PATIENTS 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 9931334 Dec. 28, 2026 TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 9931334 Dec. 28, 2026 TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER HAVING IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA USING A SOLID COMPOSITION OF ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 9931334 Dec. 28, 2026 TREATMENT OF CF WITH ELX/TEZ AND A COMP. RECITED IN CLAIM 1 OF 9931334 IN CF PATIENTS AGED ≥6 YEARS WITH AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 9670163 Dec. 28, 2026 TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 9670163 Dec. 28, 2026 TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER HAVING IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA USING A SOLID COMPOSITION OF ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 9670163 Dec. 28, 2026 TREATMENT OF CF WITH ELX/TEZ AND A COMP. OF CLAIM 1 OF 9670163 IN CF PATIENTS AGED 6 YEARS AND OLDER WITH AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 9931334 Dec. 28, 2026 TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 9931334 Dec. 28, 2026 TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER HAVING IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA USING A SOLID COMPOSITION OF ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 9931334 Dec. 28, 2026 TREATMENT OF CF WITH ELX/TEZ AND A COMP. RECITED IN CLAIM 1 OF 9931334 IN CF PATIENTS AGED ≥6 YEARS WITH AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 9670163 Dec. 28, 2026 TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS HAVING IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA USING A SOLID COMPOSITION OF ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 9670163 Dec. 28, 2026 TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 9670163 Dec. 28, 2026 TREATMENT OF CF WITH ELX/<~30% CRYSTALLINE IVA/TEZ IN CF PATIENTS AGED 2 TO <6 YEARS WITH AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 9931334 Dec. 28, 2026 TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS HAVING IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA USING A SOLID COMPOSITION OF ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 9931334 Dec. 28, 2026 TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 9931334 Dec. 28, 2026 TREATMENT OF CF WITH ELX/<~30% CRYSTALLINE IVA/TEZ IN CF PATIENTS AGED 2 TO <6 YEARS WITH AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 9670163 Dec. 28, 2026 TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS HAVING IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA USING A SOLID COMPOSITION OF ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 9670163 Dec. 28, 2026 TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 9670163 Dec. 28, 2026 TREATMENT OF CF WITH ELX/<~30% CRYSTALLINE IVA/TEZ IN CF PATIENTS AGED 2 TO <6 YEARS WITH AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 9931334 Dec. 28, 2026 TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS HAVING IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA USING A SOLID COMPOSITION OF ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 9931334 Dec. 28, 2026 TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 9931334 Dec. 28, 2026 TREATMENT OF CF WITH ELX/<~30% CRYSTALLINE IVA/TEZ IN CF PATIENTS AGED 2 TO <6 YEARS WITH AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
150MG;150MG, 100MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 Feb. 12, 2018 RX TABLET ORAL 10022352 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HETEROZYGOUS FOR F508DEL AND A SECOND CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND IVACAFTOR
150MG;150MG, 100MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 Feb. 12, 2018 RX TABLET ORAL 10022352 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HETEROZYGOUS FOR F508DEL AND A SECOND CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND IVACAFTOR
150MG;150MG, 100MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 Feb. 12, 2018 RX TABLET ORAL 10239867 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVE AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH AN EFFECTIVE AMOUNT OF TEZACAFTOR AND IVACAFTOR
150MG;150MG, 100MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 Feb. 12, 2018 RX TABLET ORAL 10239867 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVE AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH AN EFFECTIVE AMOUNT OF TEZACAFTOR AND IVACAFTOR
150MG;150MG, 100MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 Feb. 12, 2018 RX TABLET ORAL 11639347 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVE AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH AN EFFECTIVE AMOUNT OF TEZACAFTOR AND IVACAFTOR
150MG;150MG, 100MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 Feb. 12, 2018 RX TABLET ORAL 9974781 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVE AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND IVACAFTOR
150MG;150MG, 100MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 Feb. 12, 2018 RX TABLET ORAL 9974781 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVE AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND IVACAFTOR
75MG;75MG, 50MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 June 21, 2019 RX TABLET ORAL 10022352 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HETEROZYGOUS FOR F508DEL AND A SECOND CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND IVACAFTOR
75MG;75MG, 50MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 June 21, 2019 RX TABLET ORAL 10022352 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HETEROZYGOUS FOR F508DEL AND A SECOND CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND IVACAFTOR
75MG;75MG, 50MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 June 21, 2019 RX TABLET ORAL 10239867 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVE AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH AN EFFECTIVE AMOUNT OF TEZACAFTOR AND IVACAFTOR
75MG;75MG, 50MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 June 21, 2019 RX TABLET ORAL 10239867 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVE AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH AN EFFECTIVE AMOUNT OF TEZACAFTOR AND IVACAFTOR
75MG;75MG, 50MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 June 21, 2019 RX TABLET ORAL 11639347 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVE AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH AN EFFECTIVE AMOUNT OF TEZACAFTOR AND IVACAFTOR
75MG;75MG, 50MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 June 21, 2019 RX TABLET ORAL 9974781 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVE AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND IVACAFTOR
75MG;75MG, 50MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 June 21, 2019 RX TABLET ORAL 9974781 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVE AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND IVACAFTOR
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 10022352 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF A PHARMACEUTICAL COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 10022352 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF A PHARMACEUTICAL COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 10239867 April 9, 2027 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 10239867 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 10239867 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 10239867 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 11639347 April 9, 2027 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 11639347 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 11639347 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 9974781 April 9, 2027 TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 9974781 April 9, 2027 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 9974781 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 9974781 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 10022352 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF A PHARMACEUTICAL COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 10239867 April 9, 2027 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 10239867 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 10239867 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 11639347 April 9, 2027 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 11639347 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 11639347 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 9974781 April 9, 2027 TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 9974781 April 9, 2027 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 9974781 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 10022352 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF A PHARMACEUTICAL COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 10239867 April 9, 2027 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 10239867 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 10239867 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11639347 April 9, 2027 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11639347 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11639347 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 9974781 April 9, 2027 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 9974781 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 9974781 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 10022352 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF A PHARMACEUTICAL COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 10239867 April 9, 2027 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 10239867 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 10239867 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11639347 April 9, 2027 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11639347 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11639347 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 9974781 April 9, 2027 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 9974781 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 9974781 April 9, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
150MG;150MG, 100MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 Feb. 12, 2018 RX TABLET ORAL 8598181 May 1, 2027 TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVING AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE
75MG;75MG, 50MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 June 21, 2019 RX TABLET ORAL 8598181 May 1, 2027 TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVING AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 8598181 May 1, 2027 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 8598181 May 1, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 8598181 May 1, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 8598181 May 1, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 8598181 May 1, 2027 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 8598181 May 1, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 8598181 May 1, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 8598181 May 1, 2027 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 8598181 May 1, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 8598181 May 1, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 8598181 May 1, 2027 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 8598181 May 1, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 8598181 May 1, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
150MG KALYDECO VERTEX PHARMS N203188 Jan. 31, 2012 RX TABLET ORAL 8324242 Aug. 5, 2027 METHOD OF TREATING A PATIENT HAVING CYSTIC FIBROSIS, SUCH AS A PATIENT HAVING A G551D MUTATION IN CFTR, USING N-(5-HYDROXY-2,4-DI-TERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE
150MG KALYDECO VERTEX PHARMS N203188 Jan. 31, 2012 RX TABLET ORAL 8324242 Aug. 5, 2027 METHOD OF TREATING CYSTIC FIBROSIS
125MG;100MG ORKAMBI VERTEX PHARMS INC N206038 Sept. 28, 2016 RX TABLET ORAL 8324242 Aug. 5, 2027 METHOD OF TREATING A PATIENT HAVING CYSTIC FIBROSIS USING IVACAFTOR AND LUMACAFTOR
125MG;200MG ORKAMBI VERTEX PHARMS INC N206038 July 2, 2015 RX TABLET ORAL 8324242 Aug. 5, 2027 METHOD OF TREATING A PATIENT HAVING CYSTIC FIBROSIS USING IVACAFTOR AND LUMACAFTOR
125MG;200MG ORKAMBI VERTEX PHARMS INC N206038 July 2, 2015 RX TABLET ORAL 8324242 Aug. 5, 2027 METHOD OF TREATING CYSTIC FIBROSIS
13.4MG/PACKET KALYDECO VERTEX PHARMS INC N207925 May 3, 2023 RX GRANULE ORAL 8324242 Aug. 5, 2027 TREATMENT OF CYSTIC FIBROSIS USING IVACAFTOR IN A PATIENT AGE 1 MONTH TO <4 MONTHS WHO HAS AT LEAST ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA
25MG/PACKET KALYDECO VERTEX PHARMS INC N207925 April 29, 2019 RX GRANULE ORAL 8324242 Aug. 5, 2027 METHOD OF TREATING A PATIENT HAVING CYSTIC FIBROSIS, SUCH AS A PATIENT HAVING A G551D MUTATION IN CFTR, USING N-(5-HYDROXY-2,4-DI-TERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE
25MG/PACKET KALYDECO VERTEX PHARMS INC N207925 April 29, 2019 RX GRANULE ORAL 8324242 Aug. 5, 2027 METHOD OF TREATING CYSTIC FIBROSIS
25MG/PACKET KALYDECO VERTEX PHARMS INC N207925 April 29, 2019 RX GRANULE ORAL 8324242 Aug. 5, 2027 TREATMENT OF CYSTIC FIBROSIS USING IVACAFTOR IN A PATIENT AGE 4 MONTHS TO <6 YEARS WHO HAS ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA
5.8MG/PACKET KALYDECO VERTEX PHARMS INC N207925 May 3, 2023 RX GRANULE ORAL 8324242 Aug. 5, 2027 TREATMENT OF CYSTIC FIBROSIS USING IVACAFTOR IN A PATIENT AGE 1 MONTH TO <4 MONTHS WHO HAS AT LEAST ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA
50MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL 8324242 Aug. 5, 2027 METHOD OF TREATING A PATIENT HAVING CYSTIC FIBROSIS, SUCH AS A PATIENT HAVING A G551D MUTATION IN CFTR, USING N-(5-HYDROXY-2,4-DI-TERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE
50MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL 8324242 Aug. 5, 2027 METHOD OF TREATING CYSTIC FIBROSIS
50MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL 8324242 Aug. 5, 2027 TREATMENT OF CYSTIC FIBROSIS USING IVACAFTOR IN A PATIENT AGE 6 MONTHS TO <6 YEARS WHO HAS ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA
75MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL 8324242 Aug. 5, 2027 METHOD OF TREATING A PATIENT HAVING CYSTIC FIBROSIS, SUCH AS A PATIENT HAVING A G551D MUTATION IN CFTR, USING N-(5-HYDROXY-2,4-DI-TERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE
75MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL 8324242 Aug. 5, 2027 METHOD OF TREATING CYSTIC FIBROSIS
75MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL 8324242 Aug. 5, 2027 TREATMENT OF CYSTIC FIBROSIS USING IVACAFTOR IN A PATIENT AGE 6 MONTHS TO <6 YEARS WHO HAS ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA
150MG;150MG, 100MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 Feb. 12, 2018 RX TABLET ORAL 8324242 Aug. 5, 2027 TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVING AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE
75MG;75MG, 50MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 June 21, 2019 RX TABLET ORAL 8324242 Aug. 5, 2027 TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVING AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE
125MG/PACKET;100MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Aug. 7, 2018 RX GRANULE ORAL 8324242 Aug. 5, 2027 TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND IVACAFTOR
188MG/PACKET;150MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Aug. 7, 2018 RX GRANULE ORAL 8324242 Aug. 5, 2027 TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND IVACAFTOR
94MG/PACKET;75MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Sept. 2, 2022 RX GRANULE ORAL 8324242 Aug. 5, 2027 TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 1-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND IVACAFTOR
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 8324242 Aug. 5, 2027 TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 8324242 Aug. 5, 2027 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 8324242 Aug. 5, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 8324242 Aug. 5, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 8324242 Aug. 5, 2027 TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 8324242 Aug. 5, 2027 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 8324242 Aug. 5, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 8324242 Aug. 5, 2027 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 8324242 Aug. 5, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 8324242 Aug. 5, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 8324242 Aug. 5, 2027 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 8324242 Aug. 5, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 8324242 Aug. 5, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
150MG;150MG, 100MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 Feb. 12, 2018 RX TABLET ORAL 8415387 Nov. 12, 2027 TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVING AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE
75MG;75MG, 50MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 June 21, 2019 RX TABLET ORAL 8415387 Nov. 12, 2027 TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVING AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 8415387 Nov. 12, 2027 TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 8415387 Nov. 12, 2027 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 8415387 Nov. 12, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 8415387 Nov. 12, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 8415387 Nov. 12, 2027 TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 8415387 Nov. 12, 2027 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 8415387 Nov. 12, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 8415387 Nov. 12, 2027 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 8415387 Nov. 12, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 8415387 Nov. 12, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 8415387 Nov. 12, 2027 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 8415387 Nov. 12, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 8415387 Nov. 12, 2027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
125MG;100MG ORKAMBI VERTEX PHARMS INC N206038 Sept. 28, 2016 RX TABLET ORAL 10597384 Dec. 4, 2028 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS 6 YEARS AND OLDER WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING A PHARMACEUTICAL COMPOSITION ACCORDING TO CLAIM 2 OF U.S. PATENT NO. 10,597,384, FURTHER COMPRISING IVACAFTOR
125MG;100MG ORKAMBI VERTEX PHARMS INC N206038 Sept. 28, 2016 RX TABLET ORAL 11052075 Dec. 4, 2028 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS 6 YEARS AND OLDER WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE TABLET ACCORDING TO CLAIM 1 OF U.S. PATENT NO. 11,052,075, WHERE THE TABLET FURTHER COMPRISES IVACAFTOR
125MG;100MG ORKAMBI VERTEX PHARMS INC N206038 Sept. 28, 2016 RX TABLET ORAL 12065432 Dec. 4, 2028 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO ARE HOMOZYGOUS FOR THE F508DEL CFTR GENE MUTATION COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF IVA AND FORM I LUM AS RECITED IN, E.G., CLAIM 1 OF US 12065432
125MG;100MG ORKAMBI VERTEX PHARMS INC N206038 Sept. 28, 2016 RX TABLET ORAL 9150552 Dec. 4, 2028 METHOD OF TREATING CYSTIC FIBROSIS IN A PATIENT, THE PATIENT HAVING THE F508DEL MUTATION IN CFTR, USING IVACAFTOR AND FORM I LUMACAFTOR
125MG;200MG ORKAMBI VERTEX PHARMS INC N206038 July 2, 2015 RX TABLET ORAL 10076513 Dec. 4, 2028 TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 12 YEARS OR OLDER WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE TABLET COMPRISING LUMACAFTOR AS RECITED IN CLAIM 1, 19, OR 21 OF U.S. PATENT NO. 10,076,513 AND IVACAFTOR
125MG;200MG ORKAMBI VERTEX PHARMS INC N206038 July 2, 2015 RX TABLET ORAL 10597384 Dec. 4, 2028 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS 6 YEARS AND OLDER WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING A PHARMACEUTICAL COMPOSITION ACCORDING TO CLAIM 2 OF U.S. PATENT NO. 10,597,384, FURTHER COMPRISING IVACAFTOR
125MG;200MG ORKAMBI VERTEX PHARMS INC N206038 July 2, 2015 RX TABLET ORAL 11052075 Dec. 4, 2028 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS 6 YEARS AND OLDER WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE TABLET ACCORDING TO CLAIM 1 OF U.S. PATENT NO. 11,052,075, WHERE THE TABLET FURTHER COMPRISES IVACAFTOR
125MG;200MG ORKAMBI VERTEX PHARMS INC N206038 July 2, 2015 RX TABLET ORAL 12065432 Dec. 4, 2028 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO ARE HOMOZYGOUS FOR THE F508DEL CFTR GENE MUTATION COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF IVA AND FORM I LUM AS RECITED IN, E.G., CLAIM 1 OF US 12065432
125MG;200MG ORKAMBI VERTEX PHARMS INC N206038 July 2, 2015 RX TABLET ORAL 9150552 Dec. 4, 2028 METHOD OF TREATING CYSTIC FIBROSIS IN A PATIENT, THE PATIENT HAVING THE F508DEL MUTATION IN CFTR, USING IVACAFTOR AND FORM I LUMACAFTOR
125MG/PACKET;100MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Aug. 7, 2018 RX GRANULE ORAL 10597384 Dec. 4, 2028 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS 2 TO 5 YEARS OLD WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING A PHARMACEUTICAL COMPOSITION ACCORDING TO CLAIM 2 OF U.S. PATENT NO. 10,597,384, FURTHER COMPRISING IVACAFTOR
125MG/PACKET;100MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Aug. 7, 2018 RX GRANULE ORAL 12065432 Dec. 4, 2028 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 1 YEAR TO 5 YEARS WHO ARE HOMOZYGOUS FOR THE F508DEL CFTR GENE MUTATION COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF IVA AND FORM I LUM AS RECITED IN, E.G., CLAIM 1 OF US 12065432
125MG/PACKET;100MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Aug. 7, 2018 RX GRANULE ORAL 9150552 Dec. 4, 2028 TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR FORM I AND IVACAFTOR
188MG/PACKET;150MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Aug. 7, 2018 RX GRANULE ORAL 10597384 Dec. 4, 2028 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS 2 TO 5 YEARS OLD WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING A PHARMACEUTICAL COMPOSITION ACCORDING TO CLAIM 2 OF U.S. PATENT NO. 10,597,384, FURTHER COMPRISING IVACAFTOR
188MG/PACKET;150MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Aug. 7, 2018 RX GRANULE ORAL 12065432 Dec. 4, 2028 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 1 YEAR TO 5 YEARS WHO ARE HOMOZYGOUS FOR THE F508DEL CFTR GENE MUTATION COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF IVA AND FORM I LUM AS RECITED IN, E.G., CLAIM 1 OF US 12065432
188MG/PACKET;150MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Aug. 7, 2018 RX GRANULE ORAL 9150552 Dec. 4, 2028 TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR FORM I AND IVACAFTOR
94MG/PACKET;75MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Sept. 2, 2022 RX GRANULE ORAL 10597384 Dec. 4, 2028 TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 1-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING A PHARMACEUTICAL COMPOSITION ACCORDING TO CLAIM 2 OF U.S. PATENT NO. 10,597,384, FURTHER COMPRISING IVACAFTOR
94MG/PACKET;75MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Sept. 2, 2022 RX GRANULE ORAL 12065432 Dec. 4, 2028 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 1 YEAR TO 5 YEARS WHO ARE HOMOZYGOUS FOR THE F508DEL CFTR GENE MUTATION COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF IVA AND FORM I LUM AS RECITED IN, E.G., CLAIM 1 OF US 12065432
94MG/PACKET;75MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Sept. 2, 2022 RX GRANULE ORAL 9150552 Dec. 4, 2028 TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 1-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR FORM I AND IVACAFTOR
125MG;100MG ORKAMBI VERTEX PHARMS INC N206038 Sept. 28, 2016 RX TABLET ORAL 8846718 July 2, 2029 METHOD OF TREATING CYSTIC FIBROSIS IN A PATIENT, THE PATIENT HAVING THE F508DEL MUTATION IN CFTR, USING IVACAFTOR AND FORM I LUMACAFTOR
125MG;200MG ORKAMBI VERTEX PHARMS INC N206038 July 2, 2015 RX TABLET ORAL 8846718 July 2, 2029 METHOD OF TREATING CYSTIC FIBROSIS IN A PATIENT, THE PATIENT HAVING THE F508DEL MUTATION IN CFTR, USING IVACAFTOR AND FORM I LUMACAFTOR
125MG;200MG ORKAMBI VERTEX PHARMS INC N206038 July 2, 2015 RX TABLET ORAL 8846718 July 2, 2029 METHOD OF TREATING CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE
125MG/PACKET;100MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Aug. 7, 2018 RX GRANULE ORAL 8846718 July 2, 2029 TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR FORM I AND IVACAFTOR
188MG/PACKET;150MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Aug. 7, 2018 RX GRANULE ORAL 8846718 July 2, 2029 TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR FORM I AND IVACAFTOR
94MG/PACKET;75MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Sept. 2, 2022 RX GRANULE ORAL 8846718 July 2, 2029 TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 1-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR FORM I AND IVACAFTOR
150MG KALYDECO VERTEX PHARMS N203188 Jan. 31, 2012 RX TABLET ORAL 11564916 Aug. 13, 2029 TREATMENT OF CF IN A PATIENT AGE 6 YEARS AND OLDER WHO HAS ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 11564916
150MG KALYDECO VERTEX PHARMS N203188 Jan. 31, 2012 RX TABLET ORAL 12458635 Aug. 13, 2029 TREATMENT OF CF IN A PATIENT AGE 6 YEARS AND OLDER WHO HAS IN THE CFTR GENE AT LEAST ONE MUTATION RESPONSIVE TO IVA BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 12458635
125MG;100MG ORKAMBI VERTEX PHARMS INC N206038 Sept. 28, 2016 RX TABLET ORAL 11564916 Aug. 13, 2029 TREATMENT OF CF IN A PATIENT AGE 6 YEARS AND OLDER WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE COMPOSITION RECITED IN CLAIM 1 OF US 11564916
125MG;100MG ORKAMBI VERTEX PHARMS INC N206038 Sept. 28, 2016 RX TABLET ORAL 12458635 Aug. 13, 2029 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO ARE HOMOZYGOUS FOR THE F508DEL CFTR GENE MUTATION COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF IVA AS RECITED IN, E.G., CLAIM 1 OF US 12458635, AND FORM I LUM
125MG;200MG ORKAMBI VERTEX PHARMS INC N206038 July 2, 2015 RX TABLET ORAL 11564916 Aug. 13, 2029 TREATMENT OF CF IN A PATIENT AGE 6 YEARS AND OLDER WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE COMPOSITION RECITED IN CLAIM 1 OF US 11564916
125MG;200MG ORKAMBI VERTEX PHARMS INC N206038 July 2, 2015 RX TABLET ORAL 12458635 Aug. 13, 2029 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO ARE HOMOZYGOUS FOR THE F508DEL CFTR GENE MUTATION COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF IVA AS RECITED IN, E.G., CLAIM 1 OF US 12458635, AND FORM I LUM
13.4MG/PACKET KALYDECO VERTEX PHARMS INC N207925 May 3, 2023 RX GRANULE ORAL 11564916 Aug. 13, 2029 TREATMENT OF CF IN A PATIENT AGE 1 MONTH TO <4 MONTHS WHO HAS AT LEAST ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 11564916
13.4MG/PACKET KALYDECO VERTEX PHARMS INC N207925 May 3, 2023 RX GRANULE ORAL 12458635 Aug. 13, 2029 TREATMENT OF CF IN A PATIENT AGE 1 MONTH TO LESS THAN 6 YEARS OLD WHO HAS IN THE CFTR GENE AT LEAST ONE MUTATION RESPONSIVE TO IVA BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 12458635
25MG/PACKET KALYDECO VERTEX PHARMS INC N207925 April 29, 2019 RX GRANULE ORAL 11564916 Aug. 13, 2029 TREATMENT OF CF IN A PATIENT AGE 4 MONTHS TO <6 YEARS WHO HAS ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 11564916
25MG/PACKET KALYDECO VERTEX PHARMS INC N207925 April 29, 2019 RX GRANULE ORAL 12458635 Aug. 13, 2029 TREATMENT OF CF IN A PATIENT AGE 1 MONTH TO LESS THAN 6 YEARS OLD WHO HAS IN THE CFTR GENE AT LEAST ONE MUTATION RESPONSIVE TO IVA BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 12458635
5.8MG/PACKET KALYDECO VERTEX PHARMS INC N207925 May 3, 2023 RX GRANULE ORAL 11564916 Aug. 13, 2029 TREATMENT OF CF IN A PATIENT AGE 1 MONTH TO <4 MONTHS WHO HAS AT LEAST ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 11564916
5.8MG/PACKET KALYDECO VERTEX PHARMS INC N207925 May 3, 2023 RX GRANULE ORAL 12458635 Aug. 13, 2029 TREATMENT OF CF IN A PATIENT AGE 1 MONTH TO LESS THAN 6 YEARS OLD WHO HAS IN THE CFTR GENE AT LEAST ONE MUTATION RESPONSIVE TO IVA BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 12458635
50MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL 11564916 Aug. 13, 2029 TREATMENT OF CF IN A PATIENT AGE 4 MONTHS TO <6 YEARS WHO HAS ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 11564916
50MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL 12458635 Aug. 13, 2029 TREATMENT OF CF IN A PATIENT AGE 1 MONTH TO LESS THAN 6 YEARS OLD WHO HAS IN THE CFTR GENE AT LEAST ONE MUTATION RESPONSIVE TO IVA BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 12458635
75MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL 11564916 Aug. 13, 2029 TREATMENT OF CF IN A PATIENT AGE 4 MONTHS TO <6 YEARS WHO HAS ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 11564916
75MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL 12458635 Aug. 13, 2029 TREATMENT OF CF IN A PATIENT AGE 1 MONTH TO LESS THAN 6 YEARS OLD WHO HAS IN THE CFTR GENE AT LEAST ONE MUTATION RESPONSIVE TO IVA BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 12458635
150MG;150MG, 100MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 Feb. 12, 2018 RX TABLET ORAL 11564916 Aug. 13, 2029 TREATMENT OF CF IN A PATIENT AGE 6 YEARS AND OLDER WHO IS HOMOZYGOUS FOR F508DEL OR HAS AT LEAST ONE CFTR GENE MUTATION RESPONSIVE TO TEZ/IVA BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE USING THE COMPOSITION RECITED IN US 11564916 CLAIM 1
150MG;150MG, 100MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 Feb. 12, 2018 RX TABLET ORAL 12458635 Aug. 13, 2029 TREATMENT OF CF IN A PATIENT AGE 6 YEARS AND OLDER WHO IS HOMOZYGOUS FOR F508DEL OR HAS AT LEAST ONE CFTR GENE MUTATION RESPONSIVE TO TEZ/IVA BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE USING THE COMPOSITION RECITED IN US 12458635 CLAIM 1
75MG;75MG, 50MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 June 21, 2019 RX TABLET ORAL 11564916 Aug. 13, 2029 TREATMENT OF CF IN A PATIENT AGE 6 YEARS AND OLDER WHO IS HOMOZYGOUS FOR F508DEL OR HAS AT LEAST ONE CFTR GENE MUTATION RESPONSIVE TO TEZ/IVA BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE USING THE COMPOSITION RECITED IN US 11564916 CLAIM 1
75MG;75MG, 50MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 June 21, 2019 RX TABLET ORAL 12458635 Aug. 13, 2029 TREATMENT OF CF IN A PATIENT AGE 6 YEARS AND OLDER WHO IS HOMOZYGOUS FOR F508DEL OR HAS AT LEAST ONE CFTR GENE MUTATION RESPONSIVE TO TEZ/IVA BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE USING THE COMPOSITION RECITED IN US 12458635 CLAIM 1
125MG/PACKET;100MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Aug. 7, 2018 RX GRANULE ORAL 11564916 Aug. 13, 2029 TREATMENT OF CF IN A PATIENT AGE 1 TO <6 YEARS AND WEIGHING 7 KG OR MORE WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE COMPOSITION RECITED IN CLAIM 1 OF US 11564916
125MG/PACKET;100MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Aug. 7, 2018 RX GRANULE ORAL 12458635 Aug. 13, 2029 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 1 YEAR TO 5 YEARS WHO ARE HOMOZYGOUS FOR THE F508DEL CFTR GENE MUTATION COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF IVA AS RECITED IN, E.G., CLAIM 1 OF US 12458635, AND FORM I LUM
188MG/PACKET;150MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Aug. 7, 2018 RX GRANULE ORAL 11564916 Aug. 13, 2029 TREATMENT OF CF IN A PATIENT AGE 1 TO <6 YEARS AND WEIGHING 7 KG OR MORE WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE COMPOSITION RECITED IN CLAIM 1 OF US 11564916
188MG/PACKET;150MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Aug. 7, 2018 RX GRANULE ORAL 12458635 Aug. 13, 2029 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 1 YEAR TO 5 YEARS WHO ARE HOMOZYGOUS FOR THE F508DEL CFTR GENE MUTATION COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF IVA AS RECITED IN, E.G., CLAIM 1 OF US 12458635, AND FORM I LUM
94MG/PACKET;75MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Sept. 2, 2022 RX GRANULE ORAL 11564916 Aug. 13, 2029 TREATMENT OF CF IN A PATIENT AGE 1 TO <6 YEARS AND WEIGHING 7 KG OR MORE WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE COMPOSITION RECITED IN CLAIM 1 OF US 11564916
94MG/PACKET;75MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Sept. 2, 2022 RX GRANULE ORAL 12458635 Aug. 13, 2029 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 1 YEAR TO 5 YEARS WHO ARE HOMOZYGOUS FOR THE F508DEL CFTR GENE MUTATION COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF IVA AS RECITED IN, E.G., CLAIM 1 OF US 12458635, AND FORM I LUM
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 11564916 Aug. 13, 2029 TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA BY ADMINISTERING THE COMPOSITION RECITED IN US 11564916 CLAIM 1
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 11564916 Aug. 13, 2029 TREATMENT OF CF WITH A COMP. RECITED IN CLAIM 1 OF US 11564916 IN CF PATIENTS AGED ≥6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 11564916 Aug. 13, 2029 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA BY ADMINISTERING THE COMPOSITION RECITED IN US 11564916 CLAIM 1
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 12458635 Aug. 13, 2029 TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA BY ADMINISTERING THE COMPOSITION RECITED IN US 12458635 CLAIM 1
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 12458635 Aug. 13, 2029 TREATMENT OF CF WITH A COMP. OF CLAIM 1 OF US 12458635 IN CF PATIENTS AGED ≥6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 11564916 Aug. 13, 2029 TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA BY ADMINISTERING THE COMPOSITION RECITED IN US 11564916 CLAIM 1
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 11564916 Aug. 13, 2029 TREATMENT OF CF WITH A COMP. RECITED IN CLAIM 1 OF US 11564916 IN CF PATIENTS AGED ≥6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 11564916 Aug. 13, 2029 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA BY ADMINISTERING THE COMPOSITION RECITED IN US 11564916 CLAIM 1
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 12458635 Aug. 13, 2029 TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA BY ADMINISTERING THE COMPOSITION RECITED IN US 12458635 CLAIM 1
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 12458635 Aug. 13, 2029 TREATMENT OF CF WITH A COMP. OF CLAIM 1 OF US 12458635 IN CF PATIENTS AGED ≥6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11564916 Aug. 13, 2029 TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA COMPRISING ADMINISTERING THE COMPOSITION RECITED IN US 11564916 CLAIM 1
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11564916 Aug. 13, 2029 TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA COMPRISING ADMINISTERING THE COMPOSITION RECITED IN US 11564916 CLAIM 1
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11564916 Aug. 13, 2029 TREATMENT OF CF WITH A COMP. RECITED IN CLAIM 1 OF US 11564916 IN CF PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 12458635 Aug. 13, 2029 TREATMENT OF CF IN PATIENTS AGED 2 TO < 6 YEARS OLD WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA COMPRISING ADMINISTERING THE COMPOSITION RECITED IN US 12458635 CLAIM 1
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 12458635 Aug. 13, 2029 TREATMENT OF CF WITH A COMP. OF CLAIM 1 OF US 12458635 IN CF PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11564916 Aug. 13, 2029 TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA COMPRISING ADMINISTERING THE COMPOSITION RECITED IN US 11564916 CLAIM 1
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11564916 Aug. 13, 2029 TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA COMPRISING ADMINISTERING THE COMPOSITION RECITED IN US 11564916 CLAIM 1
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11564916 Aug. 13, 2029 TREATMENT OF CF WITH A COMP. RECITED IN CLAIM 1 OF US 11564916 IN CF PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 12458635 Aug. 13, 2029 TREATMENT OF CF IN PATIENTS AGED 2 TO < 6 YEARS OLD WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA COMPRISING ADMINISTERING THE COMPOSITION RECITED IN US 12458635 CLAIM 1
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 12458635 Aug. 13, 2029 TREATMENT OF CF WITH A COMP. OF CLAIM 1 OF US 12458635 IN CF PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
125MG;100MG ORKAMBI VERTEX PHARMS INC N206038 Sept. 28, 2016 RX TABLET ORAL 9192606 Sept. 29, 2029 METHOD OF TREATING CYSTIC FIBROSIS IN A PATIENT, THE PATIENT HAVING THE F508DEL MUTATION IN CFTR, USING A DOSAGE UNIT AS DEFINED IN CLAIM 1 OF U.S. PATENT NO. 9,192,606
125MG;200MG ORKAMBI VERTEX PHARMS INC N206038 July 2, 2015 RX TABLET ORAL 9192606 Sept. 29, 2029 METHOD OF TREATING CYSTIC FIBROSIS IN A PATIENT, THE PATIENT HAVING THE F508DEL MUTATION IN CFTR, USING A DOSAGE UNIT AS DEFINED IN CLAIM 1 OF U.S. PATENT NO. 9,192,606
125MG/PACKET;100MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Aug. 7, 2018 RX GRANULE ORAL 9192606 Sept. 29, 2029 TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE DOSAGE UNIT COMPRISING LUMACAFTOR AND IVACAFTOR AS RECITED IN CLAIM 1 OF US PATENT 9192606
188MG/PACKET;150MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Aug. 7, 2018 RX GRANULE ORAL 9192606 Sept. 29, 2029 TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE DOSAGE UNIT COMPRISING LUMACAFTOR AND IVACAFTOR AS RECITED IN CLAIM 1 OF US PATENT 9192606
94MG/PACKET;75MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Sept. 2, 2022 RX GRANULE ORAL 9192606 Sept. 29, 2029 TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 1-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE DOSAGE UNIT COMPRISING LUMACAFTOR AND IVACAFTOR AS RECITED IN CLAIM 1 OF US PATENT 9192606
125MG;100MG ORKAMBI VERTEX PHARMS INC N206038 Sept. 28, 2016 RX TABLET ORAL 8716338 Sept. 20, 2030 METHOD OF TREATING CYSTIC FIBROSIS IN A PATIENT, THE PATIENT HAVING THE F508DEL MUTATION IN CFTR, USING THE DOSAGE UNIT OF CLAIM 1 OF U.S. PATENT NO. 8,716,338
125MG;200MG ORKAMBI VERTEX PHARMS INC N206038 July 2, 2015 RX TABLET ORAL 8716338 Sept. 20, 2030 METHOD OF TREATING CYSTIC FIBROSIS IN A PATIENT, THE PATIENT HAVING THE F508DEL MUTATION IN CFTR, USING THE DOSAGE UNIT OF CLAIM 1 OF U.S. PATENT NO. 8,716,338
125MG;200MG ORKAMBI VERTEX PHARMS INC N206038 July 2, 2015 RX TABLET ORAL 8716338 Sept. 20, 2030 METHOD OF TREATING CYSTIC FIBROSIS IN PATIENTS WHO HAVE THE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE.
125MG/PACKET;100MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Aug. 7, 2018 RX GRANULE ORAL 8716338 Sept. 20, 2030 TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE DOSAGE UNIT COMPRISING LUMACAFTOR AS RECITED IN CLAIM 1 OF US PATENT 8716338 AND IVACAFTOR
188MG/PACKET;150MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Aug. 7, 2018 RX GRANULE ORAL 8716338 Sept. 20, 2030 TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE DOSAGE UNIT COMPRISING LUMACAFTOR AS RECITED IN CLAIM 1 OF US PATENT 8716338 AND IVACAFTOR
94MG/PACKET;75MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Sept. 2, 2022 RX GRANULE ORAL 8716338 Sept. 20, 2030 TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 1-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE DOSAGE UNIT COMPRISING LUMACAFTOR AS RECITED IN CLAIM 1 OF US PATENT 8716338 AND IVACAFTOR
150MG;150MG, 100MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 Feb. 12, 2018 RX TABLET ORAL 10081621 March 25, 2031 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 12 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR WHO HAVE AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,081,621
150MG;150MG, 100MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 Feb. 12, 2018 RX TABLET ORAL 10081621 March 25, 2031 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 6 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR WHO HAVE AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,081,621
150MG;150MG, 100MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 Feb. 12, 2018 RX TABLET ORAL 11578062 March 25, 2031 TREATMENT OF CF IN A PATIENT AGE 6 YEARS AND OLDER WHO IS HOMOZYGOUS FOR F508DEL OR HAS AT LEAST ONE CFTR GENE MUTATION RESPONSIVE TO TEZ/IVA BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE USING THE COMPOSITION RECITED IN US 11578062 CLAIM 6 OR 13
75MG;75MG, 50MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 June 21, 2019 RX TABLET ORAL 10081621 March 25, 2031 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 12 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR WHO HAVE AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,081,621
75MG;75MG, 50MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 June 21, 2019 RX TABLET ORAL 10081621 March 25, 2031 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 6 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR WHO HAVE AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,081,621
75MG;75MG, 50MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 June 21, 2019 RX TABLET ORAL 11578062 March 25, 2031 TREATMENT OF CF IN A PATIENT AGE 6 YEARS AND OLDER WHO IS HOMOZYGOUS FOR F508DEL OR HAS AT LEAST ONE CFTR GENE MUTATION RESPONSIVE TO TEZ/IVA BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE USING THE COMPOSITION RECITED IN US 11578062 CLAIM 6 OR 13
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 10081621 March 25, 2031 TREATMENT OF CF WITH ELX/IVA AND A COMP. RECITED IN CLAIM 8 OF 10081621 IN CF PATIENTS AGED ≥6 Y WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 10081621 March 25, 2031 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 10081621
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 10081621 March 25, 2031 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 10081621
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 10081621 March 25, 2031 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 10081621
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 11578062 March 25, 2031 TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA BY ADMINISTERING ELX, IVA, AND A SOLID DISPERSION ACCORDING TO US 11578062 CLAIM 1
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 11578062 March 25, 2031 TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON IN VITRO DATA BY ADMINISTERING ELEXACAFTOR, IVACAFTOR, AND A SOLID DISPERSION OF TEZACAFTOR AND A POLYMER
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 11578062 March 25, 2031 TREATMENT OF CF WITH ELX/IVA AND A COMP. RECITED IN CLAIM 13 OF 11578062 IN CF PATIENTS ≥6 Y WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 10081621 March 25, 2031 TREATMENT OF CF WITH ELX/IVA AND A COMP. RECITED IN CLAIM 8 OF 10081621 IN CF PATIENTS AGED ≥6 Y WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 10081621 March 25, 2031 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 10081621
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 10081621 March 25, 2031 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 10081621
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 11578062 March 25, 2031 TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA BY ADMINISTERING ELX, IVA, AND A SOLID DISPERSION ACCORDING TO US 11578062 CLAIM 1
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 11578062 March 25, 2031 TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON IN VITRO DATA BY ADMINISTERING ELEXACAFTOR, IVACAFTOR, AND A SOLID DISPERSION OF TEZACAFTOR AND A POLYMER
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 11578062 March 25, 2031 TREATMENT OF CF WITH ELX/IVA AND A COMP. RECITED IN CLAIM 13 OF 11578062 IN CF PATIENTS ≥6 Y WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 10081621 March 25, 2031 TREATMENT OF CF WITH ELX/IVA AND A COMP. RECITED IN CLAIM 8 OF 10081621 IN CF PATIENTS AGED 2 TO <6 Y AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 10081621 March 25, 2031 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 10081621
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 10081621 March 25, 2031 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 10081621
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11578062 March 25, 2031 TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA BY ADMINISTERING ELX, IVA, AND A SOLID DISPERSION ACCORDING TO US 11578062 CLAIM 1
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11578062 March 25, 2031 TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON IN VITRO DATA BY ADMINISTERING ELEXACAFTOR, IVACAFTOR, AND A SOLID DISPERSION OF TEZACAFTOR AND A POLYMER
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11578062 March 25, 2031 TREATMENT OF CF WITH ELX/IVA AND A COMP. RECITED IN CLAIM 13 OF 11578062 IN CF PATIENTS 2 TO <6 Y WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 10081621 March 25, 2031 TREATMENT OF CF WITH ELX/IVA AND A COMP. RECITED IN CLAIM 8 OF 10081621 IN CF PATIENTS AGED 2 TO <6 Y AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 10081621 March 25, 2031 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 10081621
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 10081621 March 25, 2031 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 10081621
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11578062 March 25, 2031 TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA BY ADMINISTERING ELX, IVA, AND A SOLID DISPERSION ACCORDING TO US 11578062 CLAIM 1
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11578062 March 25, 2031 TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON IN VITRO DATA BY ADMINISTERING ELEXACAFTOR, IVACAFTOR, AND A SOLID DISPERSION OF TEZACAFTOR AND A POLYMER
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11578062 March 25, 2031 TREATMENT OF CF WITH ELX/IVA AND A COMP. RECITED IN CLAIM 13 OF 11578062 IN CF PATIENTS 2 TO <6 Y WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
13.4MG/PACKET KALYDECO VERTEX PHARMS INC N207925 May 3, 2023 RX GRANULE ORAL 10272046 Feb. 27, 2033 TREATMENT OF CF IN A PATIENT AGE 1 MONTH TO <4 MONTHS WHO HAS AT LEAST ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 10272046
13.4MG/PACKET KALYDECO VERTEX PHARMS INC N207925 May 3, 2023 RX GRANULE ORAL 11147770 Feb. 27, 2033 TREATMENT OF CF IN A PATIENT AGE 1 MONTH TO <4 MONTHS WHO HAS AT LEAST ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 11147770
13.4MG/PACKET KALYDECO VERTEX PHARMS INC N207925 May 3, 2023 RX GRANULE ORAL 11752106 Feb. 27, 2033 TREATMENT OF CF IN A PATIENT AGE 1 MONTH TO <6 YEARS WHO HAS AT LEAST ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 11752106
13.4MG/PACKET KALYDECO VERTEX PHARMS INC N207925 May 3, 2023 RX GRANULE ORAL 12214083 Feb. 27, 2033 TREATMENT OF CF IN A PATIENT AGE 1 MONTH TO <4 MONTHS WHO HAS IN THE CFTR GENE AT LEAST ONE RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 12214083
25MG/PACKET KALYDECO VERTEX PHARMS INC N207925 April 29, 2019 RX GRANULE ORAL 10272046 Feb. 27, 2033 TREATMENT OF CF IN A PATIENT AGE 4 MONTHS TO <6 YEARS WHO HAS ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 10272046
25MG/PACKET KALYDECO VERTEX PHARMS INC N207925 April 29, 2019 RX GRANULE ORAL 11147770 Feb. 27, 2033 TREATMENT OF CF IN A PATIENT AGE 4 MONTHS TO <6 YEARS WHO HAS ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 11147770
25MG/PACKET KALYDECO VERTEX PHARMS INC N207925 April 29, 2019 RX GRANULE ORAL 11752106 Feb. 27, 2033 TREATMENT OF CF IN A PATIENT AGE 1 MONTH TO <6 YEARS WHO HAS AT LEAST ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 11752106
25MG/PACKET KALYDECO VERTEX PHARMS INC N207925 April 29, 2019 RX GRANULE ORAL 12214083 Feb. 27, 2033 TREATMENT OF CF IN A PATIENT AGE 4 MONTHS TO <6 YEARS WHO HAS IN THE CFTR GENE AT LEAST ONE RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 12214083
5.8MG/PACKET KALYDECO VERTEX PHARMS INC N207925 May 3, 2023 RX GRANULE ORAL 10272046 Feb. 27, 2033 TREATMENT OF CF IN A PATIENT AGE 1 MONTH TO <4 MONTHS WHO HAS AT LEAST ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 10272046
5.8MG/PACKET KALYDECO VERTEX PHARMS INC N207925 May 3, 2023 RX GRANULE ORAL 11147770 Feb. 27, 2033 TREATMENT OF CF IN A PATIENT AGE 1 MONTH TO <4 MONTHS WHO HAS AT LEAST ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 11147770
5.8MG/PACKET KALYDECO VERTEX PHARMS INC N207925 May 3, 2023 RX GRANULE ORAL 11752106 Feb. 27, 2033 TREATMENT OF CF IN A PATIENT AGE 1 MONTH TO <6 YEARS WHO HAS AT LEAST ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 11752106
5.8MG/PACKET KALYDECO VERTEX PHARMS INC N207925 May 3, 2023 RX GRANULE ORAL 12214083 Feb. 27, 2033 TREATMENT OF CF IN A PATIENT AGE 1 MONTH TO <4 MONTHS WHO HAS IN THE CFTR GENE AT LEAST ONE RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 12214083
50MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL 10272046 Feb. 27, 2033 TREATMENT OF CF IN A PATIENT AGE 6 MONTHS TO <6 YEARS WHO HAS ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 10272046
50MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL 11147770 Feb. 27, 2033 TREATMENT OF CF IN A PATIENT AGE 4 MONTHS TO <6 YEARS WHO HAS ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 11147770
50MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL 11752106 Feb. 27, 2033 TREATMENT OF CF IN A PATIENT AGE 1 MONTH TO <6 YEARS WHO HAS AT LEAST ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 11752106
50MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL 12214083 Feb. 27, 2033 TREATMENT OF CF IN A PATIENT AGE 6 MONTHS TO <6 YEARS WHO HAS IN THE CFTR GENE AT LEAST ONE RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 12214083
75MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL 10272046 Feb. 27, 2033 TREATMENT OF CF IN A PATIENT AGE 6 MONTHS TO <6 YEARS WHO HAS ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 10272046
75MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL 11147770 Feb. 27, 2033 TREATMENT OF CF IN A PATIENT AGE 4 MONTHS TO <6 YEARS WHO HAS ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 11147770
75MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL 11752106 Feb. 27, 2033 TREATMENT OF CF IN A PATIENT AGE 1 MONTH TO <6 YEARS WHO HAS AT LEAST ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 11752106
75MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL 12214083 Feb. 27, 2033 TREATMENT OF CF IN A PATIENT AGE 6 MONTHS TO <6 YEARS WHO HAS IN THE CFTR GENE AT LEAST ONE RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA USING THE COMPOSITION RECITED IN CLAIM 1 OF US 12214083
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 10272046 Feb. 27, 2033 TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA COMPRISING ADMINISTERING A COMPOSITION ACCORDING TO CLAIM 1 OF US 10272046
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 10272046 Feb. 27, 2033 TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA COMPRISING ADMINISTERING A COMPOSITION ACCORDING TO CLAIM 1 OF US 10272046
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 10272046 Feb. 27, 2033 TREATMENT OF CF WITH A COMP. OF CLAIM 1 OF US 10272046 IN CF PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11147770 Feb. 27, 2033 TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA COMPRISING ADMINISTERING A COMPOSITION ACCORDING TO CLAIM 1 OF US 11147770
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11147770 Feb. 27, 2033 TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA COMPRISING ADMINISTERING A COMPOSITION ACCORDING TO CLAIM 1 OF US 11147770
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11147770 Feb. 27, 2033 TREATMENT OF CF WITH A COMP. OF CLAIM 1 OF US 11147770 IN CF PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11752106 Feb. 27, 2033 TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA COMPRISING ADMINISTERING A COMPOSITION ACCORDING TO CLAIM 1 OF US 11752106
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11752106 Feb. 27, 2033 TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA COMPRISING ADMINISTERING A COMPOSITION ACCORDING TO CLAIM 1 OF US 11752106
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11752106 Feb. 27, 2033 TREATMENT OF CF WITH A COMP. OF CLAIM 1 OF US 11752106 IN CF PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 12214083 Feb. 27, 2033 TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA COMPRISING ADMINISTERING A COMPOSITION ACCORDING TO CLAIM 1 OF US 12,214,083
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 12214083 Feb. 27, 2033 TREATMENT OF CF WITH A COMP. OF CLAIM 1 OF US 12214083 IN CF PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 10272046 Feb. 27, 2033 TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA COMPRISING ADMINISTERING A COMPOSITION ACCORDING TO CLAIM 1 OF US 10272046
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 10272046 Feb. 27, 2033 TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA COMPRISING ADMINISTERING A COMPOSITION ACCORDING TO CLAIM 1 OF US 10272046
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 10272046 Feb. 27, 2033 TREATMENT OF CF WITH A COMP. OF CLAIM 1 OF US 10272046 IN CF PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11147770 Feb. 27, 2033 TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA COMPRISING ADMINISTERING A COMPOSITION ACCORDING TO CLAIM 1 OF US 11147770
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11147770 Feb. 27, 2033 TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA COMPRISING ADMINISTERING A COMPOSITION ACCORDING TO CLAIM 1 OF US 11147770
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11147770 Feb. 27, 2033 TREATMENT OF CF WITH A COMP. OF CLAIM 1 OF US 11147770 IN CF PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11752106 Feb. 27, 2033 TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA COMPRISING ADMINISTERING A COMPOSITION ACCORDING TO CLAIM 1 OF US 11752106
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11752106 Feb. 27, 2033 TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA COMPRISING ADMINISTERING A COMPOSITION ACCORDING TO CLAIM 1 OF US 11752106
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11752106 Feb. 27, 2033 TREATMENT OF CF WITH A COMP. OF CLAIM 1 OF US 11752106 IN CF PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 12214083 Feb. 27, 2033 TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA COMPRISING ADMINISTERING A COMPOSITION ACCORDING TO CLAIM 1 OF US 12,214,083
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 12214083 Feb. 27, 2033 TREATMENT OF CF WITH A COMP. OF CLAIM 1 OF US 12214083 IN CF PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
150MG;150MG, 100MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 Feb. 12, 2018 RX TABLET ORAL 10058546 July 15, 2033 TREATMENT OF CF IN PATIENTS 12 YEARS AND OLDER WHO HAVE A F508DEL OR G551D CFTR MUTATION AND A 2ND MUTATION SELECTED FROM R117H, A455E, 2789+5G->A, & 3849+10KBC->T, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF US 10058546
150MG;150MG, 100MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 Feb. 12, 2018 RX TABLET ORAL 10058546 July 15, 2033 TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE A F508DEL OR G551D CFTR MUTATION AND A 2ND MUTATION SELECTED FROM R117H, A455E, 2789+5G->A, AND 3849+10KBC->T, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF US 10058546
150MG;150MG, 100MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 Feb. 12, 2018 RX TABLET ORAL 9012496 July 15, 2033 TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HETEROZYGOUS FOR THE F508DEL MUTATION AND A SECOND MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR
75MG;75MG, 50MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 June 21, 2019 RX TABLET ORAL 10058546 July 15, 2033 TREATMENT OF CF IN PATIENTS 12 YEARS AND OLDER WHO HAVE A F508DEL OR G551D CFTR MUTATION AND A 2ND MUTATION SELECTED FROM R117H, A455E, 2789+5G->A, & 3849+10KBC->T, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF US 10058546
75MG;75MG, 50MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 June 21, 2019 RX TABLET ORAL 10058546 July 15, 2033 TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE A F508DEL OR G551D CFTR MUTATION AND A 2ND MUTATION SELECTED FROM R117H, A455E, 2789+5G->A, AND 3849+10KBC->T, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF US 10058546
75MG;75MG, 50MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 June 21, 2019 RX TABLET ORAL 9012496 July 15, 2033 TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HETEROZYGOUS FOR THE F508DEL MUTATION AND A SECOND MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 9012496 July 15, 2033 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH A COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR; AND ANOTHER COMPOSITION COMPRISING IVACAFTOR
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 9012496 July 15, 2033 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH A COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR; AND ANOTHER COMPOSITION COMPRISING IVACAFTOR
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 9012496 July 15, 2033 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH A COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR; AND ANOTHER COMPOSITION COMPRISING IVACAFTOR
150MG;150MG, 100MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 Feb. 12, 2018 RX TABLET ORAL 10206877 April 14, 2035 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 12 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,206,877
150MG;150MG, 100MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 Feb. 12, 2018 RX TABLET ORAL 10206877 April 14, 2035 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 6 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,206,877
150MG;150MG, 100MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 Feb. 12, 2018 RX TABLET ORAL 11951212 April 14, 2035 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 6 AND OLDER WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVE AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 11951212
75MG;75MG, 50MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 June 21, 2019 RX TABLET ORAL 10206877 April 14, 2035 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 12 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,206,877
75MG;75MG, 50MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 June 21, 2019 RX TABLET ORAL 10206877 April 14, 2035 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 6 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,206,877
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 10758534 Oct. 6, 2035 TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 10758534 Oct. 6, 2035 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 10758534 Oct. 6, 2035 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 10758534 Oct. 6, 2035 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 11426407 Oct. 6, 2035 TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH A COMPOUND OF CLAIM 1 OR COMPOSITION OF CLAIM 29 OF US11426407
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 11426407 Oct. 6, 2035 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 11426407 Oct. 6, 2035 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOUND OF CLAIM 1 OR COMPOSITION OF CLAIM 29 OF US11426407
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 10758534 Oct. 6, 2035 TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 10758534 Oct. 6, 2035 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 10758534 Oct. 6, 2035 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 11426407 Oct. 6, 2035 TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH A COMPOUND OF CLAIM 1 OR COMPOSITION OF CLAIM 29 OF US11426407
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 11426407 Oct. 6, 2035 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 11426407 Oct. 6, 2035 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOUND OF CLAIM 1 OR COMPOSITION OF CLAIM 29 OF US11426407
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 10758534 Oct. 6, 2035 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 10758534 Oct. 6, 2035 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 10758534 Oct. 6, 2035 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11426407 Oct. 6, 2035 TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH A COMPOUND OF CLAIM 1 OR COMPOSITION OF CLAIM 29 OF US 11426407
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11426407 Oct. 6, 2035 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11426407 Oct. 6, 2035 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOUND OF CLAIM 1 OR COMPOSITION OF CLAIM 29 OF US 11426407
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 10758534 Oct. 6, 2035 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 10758534 Oct. 6, 2035 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 10758534 Oct. 6, 2035 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11426407 Oct. 6, 2035 TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH A COMPOUND OF CLAIM 1 OR COMPOSITION OF CLAIM 29 OF US 11426407
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11426407 Oct. 6, 2035 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11426407 Oct. 6, 2035 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOUND OF CLAIM 1 OR COMPOSITION OF CLAIM 29 OF US 11426407
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 10793547 Dec. 8, 2037 TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 10793547 Dec. 8, 2037 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 10793547 Dec. 8, 2037 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 10793547 Dec. 8, 2037 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 11179367 Dec. 8, 2037 TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US11179367
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 11179367 Dec. 8, 2037 TREATMENT OF CF WITH A COMP. OF CLAIM 1 OF US 11179367 IN CF PATIENTS AGED ≥6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 11179367 Dec. 8, 2037 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOSITION ACCORDING TO AT LEAST ONE OF CLAIMS 1-9 OF US11179367
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 11517564 Dec. 8, 2037 TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA BY ADMINISTERING DAILY ELX (200 MG); TEZ; AND IVA
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 11517564 Dec. 8, 2037 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 11517564 Dec. 8, 2037 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA BY ADMINISTERING DAILY ELX (200 MG OR 100 MG); TEZ; AND IVA
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 10793547 Dec. 8, 2037 TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 10793547 Dec. 8, 2037 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 10793547 Dec. 8, 2037 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 11179367 Dec. 8, 2037 TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US11179367
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 11179367 Dec. 8, 2037 TREATMENT OF CF WITH A COMP. OF CLAIM 1 OF US 11179367 IN CF PATIENTS AGED ≥6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 11179367 Dec. 8, 2037 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOSITION ACCORDING TO AT LEAST ONE OF CLAIMS 1-9 OF US11179367
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 11517564 Dec. 8, 2037 TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA BY ADMINISTERING DAILY ELX (100 MG); TEZ; AND IVA
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 11517564 Dec. 8, 2037 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 11517564 Dec. 8, 2037 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA BY ADMINISTERING DAILY ELX (200 MG OR 100 MG); TEZ; AND IVA
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 10793547 Dec. 8, 2037 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 10793547 Dec. 8, 2037 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 10793547 Dec. 8, 2037 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11179367 Dec. 8, 2037 TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US11179367
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11179367 Dec. 8, 2037 TREATMENT OF CF WITH A COMP. OF CLAIM 1 OF US 11179367 IN CF PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11179367 Dec. 8, 2037 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOSITION ACCORDING TO ANY ONE OF CLAIMS 1-3 AND 7-9 OF US11179367
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11517564 Dec. 8, 2037 TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA BY ADMINISTERING DAILY ELX (100 MG OR 80 MG); TEZ; AND IVA
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11517564 Dec. 8, 2037 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11517564 Dec. 8, 2037 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA BY ADMINISTERING DAILY ELX (100 MG OR 80 MG); TEZ; AND IVA
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 10793547 Dec. 8, 2037 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 10793547 Dec. 8, 2037 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 10793547 Dec. 8, 2037 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11179367 Dec. 8, 2037 TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US11179367
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11179367 Dec. 8, 2037 TREATMENT OF CF WITH A COMP. OF CLAIM 1 OF US 11179367 IN CF PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11179367 Dec. 8, 2037 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOSITION ACCORDING TO ANY ONE OF CLAIMS 1-3 AND 7-9 OF US11179367
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11517564 Dec. 8, 2037 TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA BY ADMINISTERING DAILY ELX (100 MG OR 80 MG); TEZ; AND IVA
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11517564 Dec. 8, 2037 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 11517564 Dec. 8, 2037 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA BY ADMINISTERING DAILY ELX (100 MG OR 80 MG); TEZ; AND IVA
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 12350262 July 17, 2038 TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA BY ADMINISTERING DAILY ELX/TEZ/IVA (200 MG/100 MG/150 MG) + IVA (150 MG)
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 12350262 July 17, 2038 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 12350262 July 17, 2038 TREATMENT OF CF IN PATIENTS AGED 6 TO <12 YEARS OLD WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA BY ADMINISTERING DAILY ELX/TEZ/IVA (100 MG/50 MG/75 MG) + IVA (75 MG)
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 12350262 July 17, 2038 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 12350262 July 17, 2038 TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS OLD WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA BY ADMINISTERING DAILY ELX/TEZ/IVA (100 MG/50 MG/75 MG) + IVA (75 MG)
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL 12350262 July 17, 2038 TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL April 26, 2026 NEW PRODUCT
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL April 26, 2026 NEW PRODUCT
25MG/PACKET KALYDECO VERTEX PHARMS INC N207925 April 29, 2019 RX GRANULE ORAL April 29, 2026 TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 6 MONTHS TO LESS THAN 12 MONTHS WHO HAVE ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR POTENTIATION BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA
50MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL April 29, 2026 TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 6 MONTHS TO LESS THAN 12 MONTHS WHO HAVE ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR POTENTIATION BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA
75MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL April 29, 2026 TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 6 MONTHS TO LESS THAN 12 MONTHS WHO HAVE ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR POTENTIATION BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA
13.4MG/PACKET KALYDECO VERTEX PHARMS INC N207925 May 3, 2023 RX GRANULE ORAL May 3, 2026 NEW PATIENT POPULATION
5.8MG/PACKET KALYDECO VERTEX PHARMS INC N207925 May 3, 2023 RX GRANULE ORAL May 3, 2026 NEW PATIENT POPULATION
150MG;150MG, 100MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 Feb. 12, 2018 RX TABLET ORAL June 21, 2026 TX OF PTS W/ CYSTIC FIBROSIS (CF) AGE 6 TO <12 YRS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR W/ AT LEAST 1 MUTATION IN CF TRANSMEMBRANE CONDUCTANCE REGULATORY GENE RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE
75MG;75MG, 50MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 June 21, 2019 RX TABLET ORAL June 21, 2026 TX OF PTS W/ CYSTIC FIBROSIS (CF) AGE 6 TO <12 YRS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR W/ AT LEAST 1 MUTATION IN CF TRANSMEMBRANE CONDUCTANCE REGULATORY GENE RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL Oct. 21, 2026 INDICATED FOR THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL Oct. 21, 2026 FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
25MG/PACKET KALYDECO VERTEX PHARMS INC N207925 April 29, 2019 RX GRANULE ORAL Oct. 29, 2026 PEDIATRIC EXCLUSIVITY
50MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL Oct. 29, 2026 PEDIATRIC EXCLUSIVITY
75MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL Oct. 29, 2026 PEDIATRIC EXCLUSIVITY
13.4MG/PACKET KALYDECO VERTEX PHARMS INC N207925 May 3, 2023 RX GRANULE ORAL Nov. 3, 2026 PEDIATRIC EXCLUSIVITY
5.8MG/PACKET KALYDECO VERTEX PHARMS INC N207925 May 3, 2023 RX GRANULE ORAL Nov. 3, 2026 PEDIATRIC EXCLUSIVITY
125MG/PACKET;100MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Aug. 7, 2018 RX GRANULE ORAL Dec. 13, 2027 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
188MG/PACKET;150MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Aug. 7, 2018 RX GRANULE ORAL Dec. 13, 2027 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
94MG/PACKET;75MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Sept. 2, 2022 RX GRANULE ORAL Dec. 13, 2027 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL Dec. 20, 2027 LABELING CHANGES BASED UPON RESULTS FROM STUDY 124 (TRIAL 5)
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL Dec. 20, 2027 LABELING CHANGES BASED UPON RESULTS FROM STUDY 124 (TRIAL 5)
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL Dec. 20, 2027 LABELING CHANGES BASED UPON RESULTS FROM STUDY 124 (TRIAL 5)
150MG KALYDECO VERTEX PHARMS N203188 Jan. 31, 2012 RX TABLET ORAL Dec. 21, 2027 FOR THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 4 MONTHS AND OLDER WHO HAVE ONE OF THE ADDITIONAL MUTATIONS IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT HAVE BEEN IDENTIFIED AS RESPONSIVE TO IVACAFTOR POTENTIATION BASED ON IN VITRO DATA AND IDENTIFIED IN THE APPROVAL ON DECEMBER 21, 2020
25MG/PACKET KALYDECO VERTEX PHARMS INC N207925 April 29, 2019 RX GRANULE ORAL Dec. 21, 2027 FOR THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 4 MONTHS AND OLDER WHO HAVE ONE OF THE ADDITIONAL MUTATIONS IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT HAVE BEEN IDENTIFIED AS RESPONSIVE TO IVACAFTOR POTENTIATION BASED ON IN VITRO DATA AND IDENTIFIED IN THE APPROVAL ON DECEMBER 21, 2020
50MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL Dec. 21, 2027 FOR THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 4 MONTHS AND OLDER WHO HAVE ONE OF THE ADDITIONAL MUTATIONS IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT HAVE BEEN IDENTIFIED AS RESPONSIVE TO IVACAFTOR POTENTIATION BASED ON IN VITRO DATA AND IDENTIFIED IN THE APPROVAL ON DECEMBER 21, 2020
75MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL Dec. 21, 2027 FOR THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 4 MONTHS AND OLDER WHO HAVE ONE OF THE ADDITIONAL MUTATIONS IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT HAVE BEEN IDENTIFIED AS RESPONSIVE TO IVACAFTOR POTENTIATION BASED ON IN VITRO DATA AND IDENTIFIED IN THE APPROVAL ON DECEMBER 21, 2020
150MG;150MG, 100MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 Feb. 12, 2018 RX TABLET ORAL Dec. 21, 2027 FOR TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 6 YEARS AND OLDER WHO HAVE AT LEAST ONE OF THE ADDITIONAL MUTATIONS IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT HAVE BEEN IDENTIFIED AS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND IDENTIFIED IN THE APPROVAL ON DECEMBER 21, 2020
75MG;75MG, 50MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 June 21, 2019 RX TABLET ORAL Dec. 21, 2027 FOR TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 6 YEARS AND OLDER WHO HAVE AT LEAST ONE OF THE ADDITIONAL MUTATIONS IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT HAVE BEEN IDENTIFIED AS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND IDENTIFIED IN THE APPROVAL ON DECEMBER 21, 2020
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL Dec. 21, 2027 TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE A MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL Dec. 21, 2027 FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
13.4MG/PACKET KALYDECO VERTEX PHARMS INC N207925 May 3, 2023 RX GRANULE ORAL May 22, 2028 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
25MG/PACKET KALYDECO VERTEX PHARMS INC N207925 April 29, 2019 RX GRANULE ORAL May 22, 2028 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
5.8MG/PACKET KALYDECO VERTEX PHARMS INC N207925 May 3, 2023 RX GRANULE ORAL May 22, 2028 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
50MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL May 22, 2028 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
75MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL May 22, 2028 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL June 8, 2028 FOR THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 6 THROUGH 11 YEARS OLD WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL June 8, 2028 FOR THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 6 THROUGH 11 YEARS OLD WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA
125MG/PACKET;100MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Aug. 7, 2018 RX GRANULE ORAL June 13, 2028 PEDIATRIC EXCLUSIVITY
188MG/PACKET;150MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Aug. 7, 2018 RX GRANULE ORAL June 13, 2028 PEDIATRIC EXCLUSIVITY
94MG/PACKET;75MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Sept. 2, 2022 RX GRANULE ORAL June 13, 2028 PEDIATRIC EXCLUSIVITY
150MG KALYDECO VERTEX PHARMS N203188 Jan. 31, 2012 RX TABLET ORAL June 21, 2028 PEDIATRIC EXCLUSIVITY
25MG/PACKET KALYDECO VERTEX PHARMS INC N207925 April 29, 2019 RX GRANULE ORAL June 21, 2028 PEDIATRIC EXCLUSIVITY
50MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL June 21, 2028 PEDIATRIC EXCLUSIVITY
75MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL June 21, 2028 PEDIATRIC EXCLUSIVITY
13.4MG/PACKET KALYDECO VERTEX PHARMS INC N207925 May 3, 2023 RX GRANULE ORAL Nov. 22, 2028 PEDIATRIC EXCLUSIVITY
25MG/PACKET KALYDECO VERTEX PHARMS INC N207925 April 29, 2019 RX GRANULE ORAL Nov. 22, 2028 PEDIATRIC EXCLUSIVITY
5.8MG/PACKET KALYDECO VERTEX PHARMS INC N207925 May 3, 2023 RX GRANULE ORAL Nov. 22, 2028 PEDIATRIC EXCLUSIVITY
50MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL Nov. 22, 2028 PEDIATRIC EXCLUSIVITY
75MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL Nov. 22, 2028 PEDIATRIC EXCLUSIVITY
125MG/PACKET;100MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Aug. 7, 2018 RX GRANULE ORAL Sept. 2, 2029 TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 1 YEAR TO LESS THAN 2 YEARS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE
188MG/PACKET;150MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Aug. 7, 2018 RX GRANULE ORAL Sept. 2, 2029 TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 1 YEAR TO LESS THAN 2 YEARS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE
94MG/PACKET;75MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Sept. 2, 2022 RX GRANULE ORAL Sept. 2, 2029 TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 1 YEAR TO LESS THAN 2 YEARS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE
125MG/PACKET;100MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Aug. 7, 2018 RX GRANULE ORAL March 2, 2030 PEDIATRIC EXCLUSIVITY
188MG/PACKET;150MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Aug. 7, 2018 RX GRANULE ORAL March 2, 2030 PEDIATRIC EXCLUSIVITY
94MG/PACKET;75MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Sept. 2, 2022 RX GRANULE ORAL March 2, 2030 PEDIATRIC EXCLUSIVITY
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL April 26, 2030 TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 2 YEARS TO LESS THAN 6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL April 26, 2030 TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 2 YEARS TO LESS THAN 6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA
13.4MG/PACKET KALYDECO VERTEX PHARMS INC N207925 May 3, 2023 RX GRANULE ORAL May 3, 2030 THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS 1 MONTH TO LESS THAN 4 MONTHS OF AGE WHO HAVE AT LEAST ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR POTENTIATION BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA
5.8MG/PACKET KALYDECO VERTEX PHARMS INC N207925 May 3, 2023 RX GRANULE ORAL May 3, 2030 THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS 1 MONTH TO LESS THAN 4 MONTHS OF AGE WHO HAVE AT LEAST ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR POTENTIATION BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA
13.4MG/PACKET KALYDECO VERTEX PHARMS INC N207925 May 3, 2023 RX GRANULE ORAL Nov. 3, 2030 PEDIATRIC EXCLUSIVITY
5.8MG/PACKET KALYDECO VERTEX PHARMS INC N207925 May 3, 2023 RX GRANULE ORAL Nov. 3, 2030 PEDIATRIC EXCLUSIVITY
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL Dec. 20, 2031 TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 2 YEARS AND OLDER WHO HAVE ONE OF THE ADDITIONAL MUTATIONS IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT IS RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA AND IDENTIFIED IN THE APPROVAL ON DECEMBER 20,2024
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL Dec. 20, 2031 TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 2 YEARS AND OLDER WHO HAVE ONE OF THE ADDITIONAL MUTATIONS IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT IS RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA AND IDENTIFIED IN THE APPROVAL ON DECEMBER 20,2024
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL Dec. 20, 2031 TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 2 YEARS AND OLDER WHO HAVE ONE OF THE ADDITIONAL MUTATIONS IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT IS RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA AND IDENTIFIED IN THE APPROVAL ON DECEMBER 20,2024
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL Dec. 20, 2031 TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 2 YEARS AND OLDER WHO HAVE ONE OF THE ADDITIONAL MUTATIONS IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT IS RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA AND IDENTIFIED IN THE APPROVAL ON DECEMBER 20,2024
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL March 27, 2033 TREATMENT OF CYSTIC FIBROSIS (CF) IN ADULT AND PEDIATRIC PATIENTS AGED 2 YEARS AND OLDER WHO HAVE A CLINICAL DIAGNOSIS OF CF AND WHO HAVE AT LEAST ONE VARIANT IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN AND IDENTIFIED IN THE APPROVAL ON MARCH 27, 2026, EXCLUDING PATIENTS COVERED BY PREVIOUS APPROVALS FOR TRIKAFTA
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL March 27, 2033 TREATMENT OF CYSTIC FIBROSIS (CF) IN ADULT AND PEDIATRIC PATIENTS AGED 2 YEARS AND OLDER WHO HAVE A CLINICAL DIAGNOSIS OF CF AND WHO HAVE AT LEAST ONE VARIANT IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN AND IDENTIFIED IN THE APPROVAL ON MARCH 27, 2026, EXCLUDING PATIENTS COVERED BY PREVIOUS APPROVALS FOR TRIKAFTA
100MG, 75MG, 50MG;75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL March 27, 2033 TREATMENT OF CYSTIC FIBROSIS (CF) IN ADULT AND PEDIATRIC PATIENTS AGED 2 YEARS AND OLDER WHO HAVE A CLINICAL DIAGNOSIS OF CF AND WHO HAVE AT LEAST ONE VARIANT IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN AND IDENTIFIED IN THE APPROVAL ON MARCH 27, 2026, EXCLUDING PATIENTS COVERED BY PREVIOUS APPROVALS FOR TRIKAFTA
80MG, 60MG, 40MG;59.5MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N217660 April 26, 2023 RX GRANULE ORAL March 27, 2033 TREATMENT OF CYSTIC FIBROSIS (CF) IN ADULT AND PEDIATRIC PATIENTS AGED 2 YEARS AND OLDER WHO HAVE A CLINICAL DIAGNOSIS OF CF AND WHO HAVE AT LEAST ONE VARIANT IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN AND IDENTIFIED IN THE APPROVAL ON MARCH 27, 2026, EXCLUDING PATIENTS COVERED BY PREVIOUS APPROVALS FOR TRIKAFTA

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Cystic fibrosis transmembrane conductance regulator Ion channel POSITIVE MODULATOR EC50 8.52 CHEMBL CHEMBL

External reference:

IDSource
D09916 KEGG_DRUG
4031568 VANDF
CHEBI:66901 CHEBI
CHEMBL2010601 ChEMBL_ID
C545203 MESH_SUPPLEMENTAL_RECORD_UI
4342 IUPHAR_LIGAND_ID
DB08820 DRUGBANK_ID
1Y740ILL1Z UNII
1243041 RXNORM
187124 MMSL
28301 MMSL
d07826 MMSL
014156 NDDF
703823007 SNOMEDCT_US
703824001 SNOMEDCT_US
C3264621 UMLSCUI
VX7 PDB_CHEM_ID
9263 INN_ID
16220172 PUBCHEM_CID
1Y740ILL1Z INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
ORKAMBI HUMAN PRESCRIPTION DRUG LABEL 2 51167-122 GRANULE 94 mg ORAL NDA 33 sections
ORKAMBI HUMAN PRESCRIPTION DRUG LABEL 2 51167-122 GRANULE 94 mg ORAL NDA 33 sections
Kalydeco HUMAN PRESCRIPTION DRUG LABEL 1 51167-200 TABLET, FILM COATED 150 mg ORAL NDA 29 sections
Kalydeco HUMAN PRESCRIPTION DRUG LABEL 1 51167-200 TABLET, FILM COATED 150 mg ORAL NDA 29 sections
Kalydeco HUMAN PRESCRIPTION DRUG LABEL 1 51167-300 GRANULE 50 mg ORAL NDA 29 sections
Kalydeco HUMAN PRESCRIPTION DRUG LABEL 1 51167-300 GRANULE 50 mg ORAL NDA 29 sections
Kalydeco HUMAN PRESCRIPTION DRUG LABEL 1 51167-400 GRANULE 75 mg ORAL NDA 29 sections
Kalydeco HUMAN PRESCRIPTION DRUG LABEL 1 51167-400 GRANULE 75 mg ORAL NDA 29 sections
ORKAMBI HUMAN PRESCRIPTION DRUG LABEL 2 51167-500 GRANULE 188 mg ORAL NDA 33 sections
ORKAMBI HUMAN PRESCRIPTION DRUG LABEL 2 51167-500 GRANULE 188 mg ORAL NDA 33 sections
Kalydeco HUMAN PRESCRIPTION DRUG LABEL 1 51167-600 GRANULE 25 mg ORAL NDA 29 sections
Kalydeco HUMAN PRESCRIPTION DRUG LABEL 1 51167-600 GRANULE 25 mg ORAL NDA 29 sections
ORKAMBI HUMAN PRESCRIPTION DRUG LABEL 2 51167-700 TABLET, FILM COATED 125 mg ORAL NDA 33 sections
ORKAMBI HUMAN PRESCRIPTION DRUG LABEL 2 51167-700 TABLET, FILM COATED 125 mg ORAL NDA 33 sections
Kalydeco HUMAN PRESCRIPTION DRUG LABEL 1 51167-770 GRANULE 13.40 mg ORAL NDA 29 sections
Kalydeco HUMAN PRESCRIPTION DRUG LABEL 1 51167-770 GRANULE 13.40 mg ORAL NDA 29 sections
Kalydeco HUMAN PRESCRIPTION DRUG LABEL 1 51167-785 GRANULE 5.80 mg ORAL NDA 29 sections
Kalydeco HUMAN PRESCRIPTION DRUG LABEL 1 51167-785 GRANULE 5.80 mg ORAL NDA 29 sections
ORKAMBI HUMAN PRESCRIPTION DRUG LABEL 2 51167-809 TABLET, FILM COATED 125 mg ORAL NDA 33 sections
ORKAMBI HUMAN PRESCRIPTION DRUG LABEL 2 51167-809 TABLET, FILM COATED 125 mg ORAL NDA 33 sections
ORKAMBI HUMAN PRESCRIPTION DRUG LABEL 2 51167-900 GRANULE 125 mg ORAL NDA 33 sections
ORKAMBI HUMAN PRESCRIPTION DRUG LABEL 2 51167-900 GRANULE 125 mg ORAL NDA 33 sections