ivacaftor 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
cystic fibrosis transmembrane regulator (CFTR) protein modulators 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

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 1024.84 37.60 186 1682 7723 50595533
Hospitalisation 176.94 37.60 73 1795 67864 50535392
Pulmonary function test decreased 97.20 37.60 23 1845 3365 50599891
Cystic fibrosis respiratory infection suppression 72.73 37.60 12 1856 268 50602988
Infection 68.30 37.60 54 1814 172900 50430356
Haemoptysis 64.67 37.60 27 1841 25546 50577710
Pancreatitis 40.39 37.60 23 1845 42591 50560665

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 539.61 46.70 106 1088 6130 29567203
Hospitalisation 158.92 46.70 62 1132 45926 29527407
Forced expiratory volume decreased 53.60 46.70 14 1180 2799 29570534
Cystic fibrosis respiratory infection suppression 53.33 46.70 9 1185 211 29573122
Product dose omission issue 48.42 46.70 36 1158 96347 29476986

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 1108.95 39.71 211 2114 11585 64484822
Hospitalisation 181.22 39.71 76 2249 75131 64421276
Haemoptysis 89.99 39.71 41 2284 49007 64447400
Cystic fibrosis respiratory infection suppression 88.87 39.71 15 2310 396 64496011
Product dose omission issue 74.20 39.71 59 2266 194688 64301719
Pulmonary function test decreased 73.86 39.71 21 2304 6440 64489967
Sputum increased 46.93 39.71 13 2312 3622 64492785
Alanine aminotransferase increased 46.28 39.71 39 2286 138992 64357415
Cough 45.38 39.71 55 2270 302093 64194314
Pneumonia 44.32 39.71 75 2250 559501 63936906
Gamma-glutamyltransferase increased 40.72 39.71 24 2301 48486 64447921

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 D065101 Chloride Channel Agonists
MeSH PA D049990 Membrane Transport Modulators
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 cystic fibrosis transmembrane conductance regulator potentiators
CHEBI has role CHEBI:71031 orphan drugs

Drug Use (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 8629162 June 24, 2025 USE OF IVACAFTOR FOR TREATING CYSTIC FIBROSIS IN A PATIENT WITH A MILD TO MODERATE CF PHENOTYPE WITH 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 8629162 June 24, 2025 TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF USING IVACAFTOR 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
25MG/PACKET KALYDECO VERTEX PHARMS INC N207925 April 29, 2019 RX GRANULE ORAL 8629162 June 24, 2025 USE OF IVACAFTOR FOR TREATING CYSTIC FIBROSIS IN A PATIENT WITH A MILD TO MODERATE CF PHENOTYPE WITH 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 8629162 June 24, 2025 TREATMENT OF A MODERATE MILD CLINICAL PHENOTYPE OF CF USING IVACAFTOR IN A PATIENT AGE 6 MONTHS TO <6 YEARS WHO HAS ONE CFTR MUTATION REPSONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA
50MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL 8629162 June 24, 2025 USE OF IVACAFTOR FOR TREATING CYSTIC FIBROSIS IN A PATIENT WITH A MILD TO MODERATE CF PHENOTYPE WITH AT LEAST 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 8629162 June 24, 2025 TREATMENT OF A MODERATE MILD CLINICAL PHENOTYPE OF CF USING IVACAFTOR IN A PATIENT AGE 6 MONTHS TO <6 YEARS WHO HAS ONE CFTR MUTATION REPSONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA
75MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL 8629162 June 24, 2025 USE OF IVACAFTOR FOR TREATING CYSTIC FIBROSIS IN A PATIENT WITH A MILD TO MODERATE CF PHENOTYPE WITH AT LEAST 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 8629162 June 24, 2025 TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF PATIENTS WITH A MILD TO MODERATE CLINICAL PHENOTYPE OF CYSTIC FIBROSIS 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 8629162 June 24, 2025 TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF PATIENTS WITH A MILD TO MODERATE CLINICAL PHENOTYPE OF CYSTIC FIBROSIS 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 8629162 June 24, 2025 TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF 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 ELX, TEZ, AND IVA
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL 8629162 June 24, 2025 TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL 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 8629162 June 24, 2025 TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF 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 ELX, TEZ, AND IVA
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL 8629162 June 24, 2025 TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF 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 ELX, TEZ, AND IVA
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
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
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 12 YEARS AND OLDER WHO HAVE ONE F508DEL MUTATION AND ONE 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
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
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
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
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
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 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE USING A SOLID COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AMORPHOUS IVACAFTOR, AND LESS THAN ABOUT 30% CRYSTALLINE IVACAFTOR
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 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE USING A SOLID COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AMORPHOUS IVACAFTOR, AND LESS THAN ABOUT 30% CRYSTALLINE IVACAFTOR
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 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
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 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 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 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 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF 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 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 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 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL 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 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 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 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
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 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 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL 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 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 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
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
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
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
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 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL 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 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 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
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 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 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL 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 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 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
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 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 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 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 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
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
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
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
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 10081621 March 25, 2031 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGES 12 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR ONE F508DEL MUTATION AND A CFTR MUTATION PREDICTED TO BE 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 AGES 6 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR ONE F508DEL MUTATION AND A CFTR MUTATION PREDICTED TO BE 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 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 10081621 March 25, 2031 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGES 12 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR ONE F508DEL MUTATION AND A CFTR MUTATION PREDICTED TO BE 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 AGES 6 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR ONE F508DEL MUTATION AND A CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,081,621
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 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE 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
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
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
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
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
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 10058546 July 15, 2033 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS 12 YEARS AND OLDER, WITH A F508DEL OR G551D CFTR GENE MUTATION AND A A455E, 2789+5G->A, OR 3849+10KBC->T MUTATION, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF U.S PATENT 10058546
150MG;150MG, 100MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 Feb. 12, 2018 RX TABLET ORAL 10058546 July 15, 2033 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS 6 YEARS AND OLDER, WITH A F508DEL OR G551D CFTR GENE MUTATION AND A A455E, 2789+5G->, OR 3849+10KBC->T MUTATION, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF U.S. PATENT 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 10058546 July 15, 2033 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS 12 YEARS AND OLDER, WITH A F508DEL OR G551D CFTR GENE MUTATION AND A A455E, 2789+5G->A, OR 3849+10KBC->T MUTATION, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF U.S PATENT 10058546
75MG;75MG, 50MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 June 21, 2019 RX TABLET ORAL 10058546 July 15, 2033 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS 6 YEARS AND OLDER, WITH A F508DEL OR G551D CFTR GENE MUTATION AND A A455E, 2789+5G->, OR 3849+10KBC->T MUTATION, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF U.S. PATENT 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 10206877 April 14, 2035 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGES 12 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR ONE F508DEL MUTATION AND A CFTR MUTATION PREDICTED TO BE 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 AGES 6 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR ONE F508DEL MUTATION AND A CFTR MUTATION PREDICTED TO BE 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 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
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 AGES 12 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR ONE F508DEL MUTATION AND A CFTR MUTATION PREDICTED TO BE 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 AGES 6 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR ONE F508DEL MUTATION AND A CFTR MUTATION PREDICTED TO BE 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 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 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL 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 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 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 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 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL 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 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 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 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 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

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
25MG/PACKET KALYDECO VERTEX PHARMS INC N207925 April 29, 2019 RX GRANULE ORAL March 17, 2022 TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGES 2 TO LESS THAN 6 YEARS WHO HAVE ONE OF THE FOLLOWING MUTATIONS IN THE CFTR GENE: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, AND R117H
50MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL March 17, 2022 TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGES 2 TO LESS THAN 6 YEARS WHO HAVE ONE OF THE FOLLOWING MUTATIONS IN THE CFTR GENE: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, AND R117H
75MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL March 17, 2022 TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGES 2 TO LESS THAN 6 YEARS WHO HAVE ONE OF THE FOLLOWING MUTATIONS IN THE CFTR GENE: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, AND R117H
25MG/PACKET KALYDECO VERTEX PHARMS INC N207925 April 29, 2019 RX GRANULE ORAL April 29, 2022 NEW PATIENT POPULATION
50MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL April 29, 2022 NEW PATIENT POPULATION
75MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL April 29, 2022 NEW PATIENT POPULATION
150MG;150MG, 100MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 Feb. 12, 2018 RX TABLET ORAL June 21, 2022 NEW PATIENT POPULATION
75MG;75MG, 50MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 June 21, 2019 RX TABLET ORAL June 21, 2022 NEW PATIENT POPULATION
125MG;100MG ORKAMBI VERTEX PHARMS INC N206038 Sept. 28, 2016 RX TABLET ORAL July 2, 2022 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 12 YEARS AND OLDER WHO ARE HOMOZYGOUS FOR F508DEL MUTATION IN THE CFTR GENE
125MG;200MG ORKAMBI VERTEX PHARMS INC N206038 July 2, 2015 RX TABLET ORAL July 2, 2022 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 12 YEARS AND OLDER WHO ARE HOMOZYGOUS FOR F508DEL MUTATION IN THE CFTR GENE
150MG;150MG, 100MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 Feb. 12, 2018 RX TABLET ORAL Feb. 12, 2023 NEW CHEMICAL ENTITY
75MG;75MG, 50MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 June 21, 2019 RX TABLET ORAL Feb. 12, 2023 NEW CHEMICAL ENTITY
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL Feb. 12, 2023 NEW CHEMICAL ENTITY
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL Feb. 12, 2023 NEW CHEMICAL ENTITY
125MG;100MG ORKAMBI VERTEX PHARMS INC N206038 Sept. 28, 2016 RX TABLET ORAL Sept. 28, 2023 TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 6-11 YEAR OLD WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE
125MG;200MG ORKAMBI VERTEX PHARMS INC N206038 July 2, 2015 RX TABLET ORAL Sept. 28, 2023 TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 6-11 YEAR OLD WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE
150MG KALYDECO VERTEX PHARMS N203188 Jan. 31, 2012 RX TABLET ORAL May 17, 2024 TX OF CF IN PTS 2 YRS AND OLDER WHO HAVE ONE OF THE FOLLOWING MUTATIONS IN THE CFTR GENE: E56K, P67L, R74W, D110E, D110H, R117C, E193K, L206W, R347H, R352Q, A455E, D579G, S945L, S977F, F1052V, K1060T, A1067T, G1069R, R1070Q, R1070W, F1074L, D1152H, D1270N
25MG/PACKET KALYDECO VERTEX PHARMS INC N207925 April 29, 2019 RX GRANULE ORAL May 17, 2024 TX OF CF IN PTS 2 YRS AND OLDER WHO HAVE ONE OF THE FOLLOWING MUTATIONS IN THE CFTR GENE: E56K, P67L, R74W, D110E, D110H, R117C, E193K, L206W, R347H, R352Q, A455E, D579G, S945L, S977F, F1052V, K1060T, A1067T, G1069R, R1070Q, R1070W, F1074L, D1152H, D1270N
50MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL May 17, 2024 TX OF CF IN PTS 2 YRS AND OLDER WHO HAVE ONE OF THE FOLLOWING MUTATIONS IN THE CFTR GENE: E56K, P67L, R74W, D110E, D110H, R117C, E193K, L206W, R347H, R352Q, A455E, D579G, S945L, S977F, F1052V, K1060T, A1067T, G1069R, R1070Q, R1070W, F1074L, D1152H, D1270N
75MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL May 17, 2024 TX OF CF IN PTS 2 YRS AND OLDER WHO HAVE ONE OF THE FOLLOWING MUTATIONS IN THE CFTR GENE: E56K, P67L, R74W, D110E, D110H, R117C, E193K, L206W, R347H, R352Q, A455E, D579G, S945L, S977F, F1052V, K1060T, A1067T, G1069R, R1070Q, R1070W, F1074L, D1152H, D1270N
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL June 8, 2024 NEW PATIENT POPULATION
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL June 8, 2024 NEW PATIENT POPULATION
150MG KALYDECO VERTEX PHARMS N203188 Jan. 31, 2012 RX TABLET ORAL July 31, 2024 TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 2 YEARS AND OLDER WHO HAVE ONE OF THE FOLLOWING MUTATIONS IN THE CFTR GENE: 711+3A-G, E831X, 2789+5G-A, 3272-26A-G, AND 3849+10KBC-T
25MG/PACKET KALYDECO VERTEX PHARMS INC N207925 April 29, 2019 RX GRANULE ORAL July 31, 2024 TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 2 YEARS AND OLDER WHO HAVE ONE OF THE FOLLOWING MUTATIONS IN THE CFTR GENE: 711+3A-G, E831X, 2789+5G-A, 3272-26A-G, AND 3849+10KBC-T
50MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL July 31, 2024 TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 2 YEARS AND OLDER WHO HAVE ONE OF THE FOLLOWING MUTATIONS IN THE CFTR GENE: 711+3A-G, E831X, 2789+5G-A, 3272-26A-G, AND 3849+10KBC-T
75MG/PACKET KALYDECO VERTEX PHARMS INC N207925 March 17, 2015 RX GRANULE ORAL July 31, 2024 TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 2 YEARS AND OLDER WHO HAVE ONE OF THE FOLLOWING MUTATIONS IN THE CFTR GENE: 711+3A-G, E831X, 2789+5G-A, 3272-26A-G, AND 3849+10KBC-T
100MG,75MG,50MG; 150MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 Oct. 21, 2019 RX TABLET ORAL Oct. 21, 2024 NEW CHEMICAL ENTITY
50MG,37.5MG,25MG; 75MG TRIKAFTA (COPACKAGED) VERTEX PHARMS INC N212273 June 8, 2021 RX TABLET ORAL Oct. 21, 2024 NEW CHEMICAL ENTITY
150MG;150MG, 100MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 Feb. 12, 2018 RX TABLET ORAL Feb. 12, 2025 TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AGED 12 YEARS AND OLDER WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR WHO HAVE AT LEAST ONE MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR GENE RESPONSIVE TO TEZACAFTOR/IVACAFTOR
75MG;75MG, 50MG SYMDEKO (COPACKAGED) VERTEX PHARMS INC N210491 June 21, 2019 RX TABLET ORAL Feb. 12, 2025 TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AGED 12 YEARS AND OLDER WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR WHO HAVE AT LEAST ONE MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR GENE RESPONSIVE TO TEZACAFTOR/IVACAFTOR
125MG/PACKET;100MG/PACKET ORKAMBI VERTEX PHARMS INC N211358 Aug. 7, 2018 RX GRANULE ORAL Aug. 7, 2025 FOR THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 2 THROUGH 5 YEARS OLD 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 Aug. 7, 2025 FOR THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 2 THROUGH 5 YEARS OLD WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE
150MG KALYDECO VERTEX PHARMS N203188 Jan. 31, 2012 RX TABLET ORAL Aug. 15, 2025 THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 12 MONTHS AND OLDER WHO HAVE ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR POTENTIATION BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA
25MG/PACKET KALYDECO VERTEX PHARMS INC N207925 April 29, 2019 RX GRANULE ORAL Aug. 15, 2025 THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 12 MONTHS AND OLDER 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 Aug. 15, 2025 THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 12 MONTHS AND OLDER 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 Aug. 15, 2025 THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 12 MONTHS AND OLDER WHO HAVE ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR POTENTIATION BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA
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
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
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
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

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
VX7 PDB_CHEM_ID
CHEMBL2010601 ChEMBL_ID
C545203 MESH_SUPPLEMENTAL_RECORD_UI
4342 IUPHAR_LIGAND_ID
9263 INN_ID
DB08820 DRUGBANK_ID
1Y740ILL1Z UNII
16220172 PUBCHEM_CID
1243041 RXNORM
187124 MMSL
28301 MMSL
d07826 MMSL
014156 NDDF
703823007 SNOMEDCT_US
703824001 SNOMEDCT_US
C3264621 UMLSCUI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Kalydeco HUMAN PRESCRIPTION DRUG LABEL 1 51167-200 TABLET, FILM COATED 150 mg ORAL NDA 28 sections
Kalydeco HUMAN PRESCRIPTION DRUG LABEL 1 51167-300 GRANULE 50 mg ORAL NDA 28 sections
Kalydeco HUMAN PRESCRIPTION DRUG LABEL 1 51167-400 GRANULE 75 mg ORAL NDA 28 sections
ORKAMBI HUMAN PRESCRIPTION DRUG LABEL 2 51167-500 GRANULE 188 mg ORAL NDA 30 sections
Kalydeco HUMAN PRESCRIPTION DRUG LABEL 1 51167-600 GRANULE 25 mg ORAL NDA 28 sections
ORKAMBI HUMAN PRESCRIPTION DRUG LABEL 2 51167-700 TABLET, FILM COATED 125 mg ORAL NDA 30 sections
ORKAMBI HUMAN PRESCRIPTION DRUG LABEL 2 51167-809 TABLET, FILM COATED 125 mg ORAL NDA 30 sections
ORKAMBI HUMAN PRESCRIPTION DRUG LABEL 2 51167-900 GRANULE 125 mg ORAL NDA 30 sections