ivacaftor 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| cystic fibrosis transmembrane regulator (CFTR) protein modulators, correctors, and amplifiers | 4228 | 873054-44-5 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
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.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.30 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| 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 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 21, 2020 | EMA | Vertex Pharmaceuticals (Ireland) Limited | |
| Jan. 31, 2012 | FDA | VERTEX PHARMS |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Infective pulmonary exacerbation of cystic fibrosis | 1051.16 | 38.29 | 193 | 2112 | 8624 | 63478093 |
| Hospitalisation | 171.68 | 38.29 | 76 | 2229 | 85005 | 63401712 |
| Pulmonary function test decreased | 99.17 | 38.29 | 24 | 2281 | 3923 | 63482794 |
| Cystic fibrosis respiratory infection suppression | 72.06 | 38.29 | 12 | 2293 | 289 | 63486428 |
| Haemoptysis | 65.33 | 38.29 | 28 | 2277 | 28698 | 63458019 |
| Infection | 57.67 | 38.29 | 55 | 2250 | 229118 | 63257599 |
| Butterfly rash | 45.64 | 38.29 | 11 | 2294 | 1762 | 63484955 |
| Exposure during pregnancy | 40.32 | 38.29 | 38 | 2267 | 155509 | 63331208 |
| Pancreatitis | 40.31 | 38.29 | 24 | 2281 | 49031 | 63437686 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Infective pulmonary exacerbation of cystic fibrosis | 548.54 | 43.43 | 110 | 1369 | 6691 | 34948761 |
| Hospitalisation | 143.04 | 43.43 | 62 | 1417 | 56840 | 34898612 |
| Forced expiratory volume decreased | 70.25 | 43.43 | 18 | 1461 | 3185 | 34952267 |
| Cystic fibrosis respiratory infection suppression | 58.76 | 43.43 | 10 | 1469 | 235 | 34955217 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Infective pulmonary exacerbation of cystic fibrosis | 1103.13 | 36.44 | 214 | 2719 | 12637 | 79728818 |
| Hospitalisation | 163.04 | 36.44 | 76 | 2857 | 94160 | 79647295 |
| Cystic fibrosis respiratory infection suppression | 94.26 | 36.44 | 16 | 2917 | 428 | 79741027 |
| Haemoptysis | 86.97 | 36.44 | 42 | 2891 | 55957 | 79685498 |
| Pulmonary function test decreased | 69.96 | 36.44 | 21 | 2912 | 7616 | 79733839 |
| Product dose omission issue | 66.53 | 36.44 | 62 | 2871 | 247475 | 79493980 |
| Forced expiratory volume decreased | 56.81 | 36.44 | 18 | 2915 | 7796 | 79733659 |
| Distal intestinal obstruction syndrome | 54.39 | 36.44 | 11 | 2922 | 776 | 79740679 |
| Alanine aminotransferase increased | 52.07 | 36.44 | 45 | 2888 | 162525 | 79578930 |
| Blood alkaline phosphatase increased | 51.56 | 36.44 | 31 | 2902 | 63633 | 79677822 |
| Sputum increased | 47.98 | 36.44 | 14 | 2919 | 4599 | 79736856 |
| Gamma-glutamyltransferase increased | 47.87 | 36.44 | 28 | 2905 | 54652 | 79686803 |
| Butterfly rash | 40.85 | 36.44 | 10 | 2923 | 1686 | 79739769 |
| Cough | 38.96 | 36.44 | 57 | 2876 | 366732 | 79374723 |
| Pneumonia | 37.80 | 36.44 | 78 | 2855 | 660168 | 79081287 |
| Pancreatitis | 37.27 | 36.44 | 26 | 2907 | 68549 | 79672906 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| 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 | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Cystic fibrosis of the lung | indication | 86555001 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 8.08 | acidic |
| pKa2 | 9.12 | acidic |
| pKa3 | 11.19 | acidic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent 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 |
| 13.4MG/PACKET | KALYDECO | VERTEX PHARMS INC | N207925 | May 3, 2023 | RX | GRANULE | ORAL | 8629162 | June 24, 2025 | TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF USING IVACAFTOR 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 |
| 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 |
| 5.8MG/PACKET | KALYDECO | VERTEX PHARMS INC | N207925 | May 3, 2023 | RX | GRANULE | ORAL | 8629162 | June 24, 2025 | TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF USING IVACAFTOR 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 |
| 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 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 | 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 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 | 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 |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 8629162 | June 24, 2025 | TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF 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 ELX, TEZ, AND IVA |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 8629162 | June 24, 2025 | TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF 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 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 |
| 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 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 |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | 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 | GRANULES | 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 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 |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | 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 | GRANULES | 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 | GRANULES | 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 | GRANULES | 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 |
| 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 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 | 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 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 | 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 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 | GRANULES | 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 | GRANULES | 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 | GRANULES | 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 | GRANULES | 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 | GRANULES | 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 | GRANULES | 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 | GRANULES | 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 | GRANULES | 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 |
| 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 |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | 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 | GRANULES | 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 |
| 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 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 |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | 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 | GRANULES | 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 |
| 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 |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | 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 | GRANULES | 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 |
| 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 |
| 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 | 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 |
| 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;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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | 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 | GRANULES | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 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 |
| 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 |
| 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 | 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;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | 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 | GRANULES | 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 | GRANULES | 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 | GRANULES | 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | 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 | GRANULES | 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 | GRANULES | 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 | GRANULES | 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 |
| 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 |
| 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 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 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 | GRANULES | 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 | GRANULES | 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 | GRANULES | 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 | GRANULES | 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 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 |
| 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 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 |
| 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 | GRANULES | 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 | GRANULES | 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 | GRANULES | 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 | GRANULES | 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 | GRANULES | 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 | GRANULES | 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 |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 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 |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | Oct. 21, 2024 | NEW CHEMICAL ENTITY |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | 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 |
| 125MG/PACKET;100MG/PACKET | ORKAMBI | VERTEX PHARMS INC | N211358 | Aug. 7, 2018 | RX | GRANULE | ORAL | Sept. 2, 2025 | NEW PATIENT POPULATION |
| 188MG/PACKET;150MG/PACKET | ORKAMBI | VERTEX PHARMS INC | N211358 | Aug. 7, 2018 | RX | GRANULE | ORAL | Sept. 2, 2025 | NEW PATIENT POPULATION |
| 94MG/PACKET;75MG/PACKET | ORKAMBI | VERTEX PHARMS INC | N211358 | Sept. 2, 2022 | RX | GRANULE | ORAL | Sept. 2, 2025 | NEW STRENGTH |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | April 26, 2026 | NEW PRODUCT |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | 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 |
| 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 |
| 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 |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | 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 | GRANULES | 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 |
| 25MG/PACKET | KALYDECO | VERTEX PHARMS INC | N207925 | April 29, 2019 | 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 |
| 50MG/PACKET | KALYDECO | VERTEX PHARMS INC | N207925 | March 17, 2015 | 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 |
| 75MG/PACKET | KALYDECO | VERTEX PHARMS INC | N207925 | March 17, 2015 | 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 |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Cystic fibrosis transmembrane conductance regulator | Ion channel | POSITIVE MODULATOR | EC50 | 8.52 | CHEMBL | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 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 |
| 1243041 | RXNORM |
| 187124 | MMSL |
| 28301 | MMSL |
| d07826 | MMSL |
| 014156 | NDDF |
| 703823007 | SNOMEDCT_US |
| 703824001 | SNOMEDCT_US |
| C3264621 | UMLSCUI |
| 16220172 | PUBCHEM_CID |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| ORKAMBI | HUMAN PRESCRIPTION DRUG LABEL | 2 | 51167-122 | GRANULE | 94 mg | ORAL | NDA | 34 sections |
| ORKAMBI | HUMAN PRESCRIPTION DRUG LABEL | 2 | 51167-122 | GRANULE | 94 mg | ORAL | NDA | 34 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 | 51167-200 | 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 | 51167-300 | 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 |
| 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 | 34 sections |
| ORKAMBI | HUMAN PRESCRIPTION DRUG LABEL | 2 | 51167-500 | GRANULE | 188 mg | ORAL | NDA | 34 sections |
| ORKAMBI | HUMAN PRESCRIPTION DRUG LABEL | 2 | 51167-500 | GRANULE | 188 mg | ORAL | NDA | 34 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 |
| 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 | 34 sections |
| ORKAMBI | HUMAN PRESCRIPTION DRUG LABEL | 2 | 51167-700 | TABLET, FILM COATED | 125 mg | ORAL | NDA | 34 sections |
| ORKAMBI | HUMAN PRESCRIPTION DRUG LABEL | 2 | 51167-700 | TABLET, FILM COATED | 125 mg | ORAL | NDA | 34 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 |
| ORKAMBI | HUMAN PRESCRIPTION DRUG LABEL | 2 | 51167-809 | TABLET, FILM COATED | 125 mg | ORAL | NDA | 34 sections |
| ORKAMBI | HUMAN PRESCRIPTION DRUG LABEL | 2 | 51167-809 | TABLET, FILM COATED | 125 mg | ORAL | NDA | 34 sections |
| ORKAMBI | HUMAN PRESCRIPTION DRUG LABEL | 2 | 51167-809 | TABLET, FILM COATED | 125 mg | ORAL | NDA | 34 sections |
| ORKAMBI | HUMAN PRESCRIPTION DRUG LABEL | 2 | 51167-900 | GRANULE | 125 mg | ORAL | NDA | 34 sections |
| ORKAMBI | HUMAN PRESCRIPTION DRUG LABEL | 2 | 51167-900 | GRANULE | 125 mg | ORAL | NDA | 34 sections |
| ORKAMBI | HUMAN PRESCRIPTION DRUG LABEL | 2 | 51167-900 | GRANULE | 125 mg | ORAL | NDA | 34 sections |