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elexacaftor 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| cystic fibrosis transmembrane regulator (CFTR) protein modulators, correctors, and amplifiers | 5372 | 2216712-66-0 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Elexacaftor and tezacaftor bind to different sites on the CFTR protein and have an additive effect in facilitating the cellular processing and trafficking of F508del-CFTR to increase the amount of CFTR protein delivered to the cell surface compared to either molecule alone. Ivacaftor potentiates the channel open probability (or gating) of the CFTR protein at the cell surface. The combined effect of elexacaftor, tezacaftor and ivacaftor is increased quantity and function of F508del-CFTR at the cell surface, resulting in increased CFTR activity as measured by CFTR mediated chloride transport.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Bocci G, Oprea TI, Benet LZ |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2B,AXL,CDK9,GRK2,PDK1,PDK2,PDK4,PIK3CA,PIK3CB,PIK3CD,PIK3CG,PRKDC | 12 | |||
| kinase-selectivity-class | PDK1 | 1 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 21, 2020 | EMA | Vertex Pharmaceuticals (Ireland) Limited | |
| Oct. 10, 2019 | FDA | VERTEX PHARMS INC |
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 |
|---|---|---|---|---|---|---|
| Pelvic kidney | 86.19 | 60.18 | 7 | 6 | 106 | 90628328 |
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | R07AX32 | RESPIRATORY SYSTEM OTHER RESPIRATORY SYSTEM PRODUCTS OTHER RESPIRATORY SYSTEM PRODUCTS Other respiratory system products |
| MeSH PA | D049990 | Membrane Transport Modulators |
| MeSH PA | D065101 | Chloride Channel Agonists |
Related Drugs by ATC class:
R07AX Other respiratory system products 6 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Cystic fibrosis | indication | 190905008 | DOID:1485 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 4.64 | acidic |
| pKa2 | 1.88 | Basic |
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 8354427 | July 6, 2026 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE A R117H MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 8354427 | July 6, 2026 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A R117H MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 8354427 | July 6, 2026 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A R117H MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 8354427 | July 6, 2026 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A R117H MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 8354427 | July 6, 2026 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A R117H MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 9670163 | Dec. 28, 2026 | TREATMENT OF CF IN PATIENTS 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 9670163 | Dec. 28, 2026 | TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 9670163 | Dec. 28, 2026 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER HAVING IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA USING A SOLID COMPOSITION OF ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 9670163 | Dec. 28, 2026 | TREATMENT OF CF WITH ELX/TEZ AND A COMP. OF CLAIM 1 OF 9670163 IN CF PATIENTS AGED 6 YEARS AND OLDER WITH AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 9931334 | Dec. 28, 2026 | TREATMENT OF CF IN PATIENTS 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 9931334 | Dec. 28, 2026 | TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 9931334 | Dec. 28, 2026 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER HAVING IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA USING A SOLID COMPOSITION OF ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 9931334 | Dec. 28, 2026 | TREATMENT OF CF WITH ELX/TEZ AND A COMP. RECITED IN CLAIM 1 OF 9931334 IN CF PATIENTS AGED ≥6 YEARS WITH AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 9670163 | Dec. 28, 2026 | TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 9670163 | Dec. 28, 2026 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER HAVING IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA USING A SOLID COMPOSITION OF ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 9670163 | Dec. 28, 2026 | TREATMENT OF CF WITH ELX/TEZ AND A COMP. OF CLAIM 1 OF 9670163 IN CF PATIENTS AGED 6 YEARS AND OLDER WITH AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 9931334 | Dec. 28, 2026 | TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 9931334 | Dec. 28, 2026 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER HAVING IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA USING A SOLID COMPOSITION OF ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 9931334 | Dec. 28, 2026 | TREATMENT OF CF WITH ELX/TEZ AND A COMP. RECITED IN CLAIM 1 OF 9931334 IN CF PATIENTS AGED ≥6 YEARS WITH AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 9670163 | Dec. 28, 2026 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS HAVING IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA USING A SOLID COMPOSITION OF ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 9670163 | Dec. 28, 2026 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 9670163 | Dec. 28, 2026 | TREATMENT OF CF WITH ELX/<~30% CRYSTALLINE IVA/TEZ IN CF PATIENTS AGED 2 TO <6 YEARS WITH AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 9931334 | Dec. 28, 2026 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS HAVING IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA USING A SOLID COMPOSITION OF ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 9931334 | Dec. 28, 2026 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 9931334 | Dec. 28, 2026 | TREATMENT OF CF WITH ELX/<~30% CRYSTALLINE IVA/TEZ IN CF PATIENTS AGED 2 TO <6 YEARS WITH AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 9670163 | Dec. 28, 2026 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS HAVING IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA USING A SOLID COMPOSITION OF ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 9670163 | Dec. 28, 2026 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 9670163 | Dec. 28, 2026 | TREATMENT OF CF WITH ELX/<~30% CRYSTALLINE IVA/TEZ IN CF PATIENTS AGED 2 TO <6 YEARS WITH AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 9931334 | Dec. 28, 2026 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS HAVING IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA USING A SOLID COMPOSITION OF ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 9931334 | Dec. 28, 2026 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 9931334 | Dec. 28, 2026 | TREATMENT OF CF WITH ELX/<~30% CRYSTALLINE IVA/TEZ IN CF PATIENTS AGED 2 TO <6 YEARS WITH AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 10022352 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF A PHARMACEUTICAL COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 10022352 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF A PHARMACEUTICAL COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 10239867 | April 9, 2027 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 10239867 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 10239867 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 10239867 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 11639347 | April 9, 2027 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 11639347 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 11639347 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 9974781 | April 9, 2027 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 9974781 | April 9, 2027 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 9974781 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 9974781 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 10022352 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF A PHARMACEUTICAL COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 10239867 | April 9, 2027 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 10239867 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 10239867 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 11639347 | April 9, 2027 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 11639347 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 11639347 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 9974781 | April 9, 2027 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 9974781 | April 9, 2027 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 9974781 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 10022352 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF A PHARMACEUTICAL COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 10239867 | April 9, 2027 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 10239867 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 10239867 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11639347 | April 9, 2027 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11639347 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11639347 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 9974781 | April 9, 2027 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 9974781 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 9974781 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 10022352 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF A PHARMACEUTICAL COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 10239867 | April 9, 2027 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 10239867 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 10239867 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11639347 | April 9, 2027 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11639347 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11639347 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 9974781 | April 9, 2027 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 9974781 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 9974781 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 8598181 | May 1, 2027 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 8598181 | May 1, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 8598181 | May 1, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 8598181 | May 1, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 8598181 | May 1, 2027 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 8598181 | May 1, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 8598181 | May 1, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 8598181 | May 1, 2027 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 8598181 | May 1, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 8598181 | May 1, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 8598181 | May 1, 2027 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 8598181 | May 1, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 8598181 | May 1, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 8324242 | Aug. 5, 2027 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 8324242 | Aug. 5, 2027 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 8324242 | Aug. 5, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 8324242 | Aug. 5, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 8324242 | Aug. 5, 2027 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 8324242 | Aug. 5, 2027 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 8324242 | Aug. 5, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 8324242 | Aug. 5, 2027 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 8324242 | Aug. 5, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 8324242 | Aug. 5, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 8324242 | Aug. 5, 2027 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 8324242 | Aug. 5, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 8324242 | Aug. 5, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 8415387 | Nov. 12, 2027 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 8415387 | Nov. 12, 2027 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 8415387 | Nov. 12, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 8415387 | Nov. 12, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 8415387 | Nov. 12, 2027 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 8415387 | Nov. 12, 2027 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 8415387 | Nov. 12, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 8415387 | Nov. 12, 2027 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 8415387 | Nov. 12, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 8415387 | Nov. 12, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 8415387 | Nov. 12, 2027 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 8415387 | Nov. 12, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 8415387 | Nov. 12, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 11564916 | Aug. 13, 2029 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA BY ADMINISTERING THE COMPOSITION RECITED IN US 11564916 CLAIM 1 |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 11564916 | Aug. 13, 2029 | TREATMENT OF CF WITH A COMP. RECITED IN CLAIM 1 OF US 11564916 IN CF PATIENTS AGED ≥6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 11564916 | Aug. 13, 2029 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA BY ADMINISTERING THE COMPOSITION RECITED IN US 11564916 CLAIM 1 |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 12458635 | Aug. 13, 2029 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA BY ADMINISTERING THE COMPOSITION RECITED IN US 12458635 CLAIM 1 |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 12458635 | Aug. 13, 2029 | TREATMENT OF CF WITH A COMP. OF CLAIM 1 OF US 12458635 IN CF PATIENTS AGED ≥6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 11564916 | Aug. 13, 2029 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA BY ADMINISTERING THE COMPOSITION RECITED IN US 11564916 CLAIM 1 |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 11564916 | Aug. 13, 2029 | TREATMENT OF CF WITH A COMP. RECITED IN CLAIM 1 OF US 11564916 IN CF PATIENTS AGED ≥6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 11564916 | Aug. 13, 2029 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA BY ADMINISTERING THE COMPOSITION RECITED IN US 11564916 CLAIM 1 |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 12458635 | Aug. 13, 2029 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA BY ADMINISTERING THE COMPOSITION RECITED IN US 12458635 CLAIM 1 |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 12458635 | Aug. 13, 2029 | TREATMENT OF CF WITH A COMP. OF CLAIM 1 OF US 12458635 IN CF PATIENTS AGED ≥6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11564916 | Aug. 13, 2029 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA COMPRISING ADMINISTERING THE COMPOSITION RECITED IN US 11564916 CLAIM 1 |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11564916 | Aug. 13, 2029 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA COMPRISING ADMINISTERING THE COMPOSITION RECITED IN US 11564916 CLAIM 1 |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11564916 | Aug. 13, 2029 | TREATMENT OF CF WITH A COMP. RECITED IN CLAIM 1 OF US 11564916 IN CF PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 12458635 | Aug. 13, 2029 | TREATMENT OF CF IN PATIENTS AGED 2 TO < 6 YEARS OLD WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA COMPRISING ADMINISTERING THE COMPOSITION RECITED IN US 12458635 CLAIM 1 |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 12458635 | Aug. 13, 2029 | TREATMENT OF CF WITH A COMP. OF CLAIM 1 OF US 12458635 IN CF PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11564916 | Aug. 13, 2029 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA COMPRISING ADMINISTERING THE COMPOSITION RECITED IN US 11564916 CLAIM 1 |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11564916 | Aug. 13, 2029 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA COMPRISING ADMINISTERING THE COMPOSITION RECITED IN US 11564916 CLAIM 1 |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11564916 | Aug. 13, 2029 | TREATMENT OF CF WITH A COMP. RECITED IN CLAIM 1 OF US 11564916 IN CF PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 12458635 | Aug. 13, 2029 | TREATMENT OF CF IN PATIENTS AGED 2 TO < 6 YEARS OLD WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA COMPRISING ADMINISTERING THE COMPOSITION RECITED IN US 12458635 CLAIM 1 |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 12458635 | Aug. 13, 2029 | TREATMENT OF CF WITH A COMP. OF CLAIM 1 OF US 12458635 IN CF PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 10081621 | March 25, 2031 | TREATMENT OF CF WITH ELX/IVA AND A COMP. RECITED IN CLAIM 8 OF 10081621 IN CF PATIENTS AGED ≥6 Y WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 10081621 | March 25, 2031 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 10081621 |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 10081621 | March 25, 2031 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 10081621 |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 10081621 | March 25, 2031 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 10081621 |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 11578062 | March 25, 2031 | TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA BY ADMINISTERING ELX, IVA, AND A SOLID DISPERSION ACCORDING TO US 11578062 CLAIM 1 |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 11578062 | March 25, 2031 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON IN VITRO DATA BY ADMINISTERING ELEXACAFTOR, IVACAFTOR, AND A SOLID DISPERSION OF TEZACAFTOR AND A POLYMER |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 11578062 | March 25, 2031 | TREATMENT OF CF WITH ELX/IVA AND A COMP. RECITED IN CLAIM 13 OF 11578062 IN CF PATIENTS ≥6 Y WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 10081621 | March 25, 2031 | TREATMENT OF CF WITH ELX/IVA AND A COMP. RECITED IN CLAIM 8 OF 10081621 IN CF PATIENTS AGED ≥6 Y WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 10081621 | March 25, 2031 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 10081621 |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 10081621 | March 25, 2031 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 10081621 |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 11578062 | March 25, 2031 | TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA BY ADMINISTERING ELX, IVA, AND A SOLID DISPERSION ACCORDING TO US 11578062 CLAIM 1 |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 11578062 | March 25, 2031 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON IN VITRO DATA BY ADMINISTERING ELEXACAFTOR, IVACAFTOR, AND A SOLID DISPERSION OF TEZACAFTOR AND A POLYMER |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 11578062 | March 25, 2031 | TREATMENT OF CF WITH ELX/IVA AND A COMP. RECITED IN CLAIM 13 OF 11578062 IN CF PATIENTS ≥6 Y WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 10081621 | March 25, 2031 | TREATMENT OF CF WITH ELX/IVA AND A COMP. RECITED IN CLAIM 8 OF 10081621 IN CF PATIENTS AGED 2 TO <6 Y AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 10081621 | March 25, 2031 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 10081621 |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 10081621 | March 25, 2031 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 10081621 |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11578062 | March 25, 2031 | TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA BY ADMINISTERING ELX, IVA, AND A SOLID DISPERSION ACCORDING TO US 11578062 CLAIM 1 |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11578062 | March 25, 2031 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON IN VITRO DATA BY ADMINISTERING ELEXACAFTOR, IVACAFTOR, AND A SOLID DISPERSION OF TEZACAFTOR AND A POLYMER |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11578062 | March 25, 2031 | TREATMENT OF CF WITH ELX/IVA AND A COMP. RECITED IN CLAIM 13 OF 11578062 IN CF PATIENTS 2 TO <6 Y WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 10081621 | March 25, 2031 | TREATMENT OF CF WITH ELX/IVA AND A COMP. RECITED IN CLAIM 8 OF 10081621 IN CF PATIENTS AGED 2 TO <6 Y AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 10081621 | March 25, 2031 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 10081621 |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 10081621 | March 25, 2031 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 10081621 |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11578062 | March 25, 2031 | TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA BY ADMINISTERING ELX, IVA, AND A SOLID DISPERSION ACCORDING TO US 11578062 CLAIM 1 |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11578062 | March 25, 2031 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON IN VITRO DATA BY ADMINISTERING ELEXACAFTOR, IVACAFTOR, AND A SOLID DISPERSION OF TEZACAFTOR AND A POLYMER |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11578062 | March 25, 2031 | TREATMENT OF CF WITH ELX/IVA AND A COMP. RECITED IN CLAIM 13 OF 11578062 IN CF PATIENTS 2 TO <6 Y WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 10272046 | Feb. 27, 2033 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA COMPRISING ADMINISTERING A COMPOSITION ACCORDING TO CLAIM 1 OF US 10272046 |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 10272046 | Feb. 27, 2033 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA COMPRISING ADMINISTERING A COMPOSITION ACCORDING TO CLAIM 1 OF US 10272046 |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 10272046 | Feb. 27, 2033 | TREATMENT OF CF WITH A COMP. OF CLAIM 1 OF US 10272046 IN CF PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11147770 | Feb. 27, 2033 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA COMPRISING ADMINISTERING A COMPOSITION ACCORDING TO CLAIM 1 OF US 11147770 |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11147770 | Feb. 27, 2033 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA COMPRISING ADMINISTERING A COMPOSITION ACCORDING TO CLAIM 1 OF US 11147770 |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11147770 | Feb. 27, 2033 | TREATMENT OF CF WITH A COMP. OF CLAIM 1 OF US 11147770 IN CF PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11752106 | Feb. 27, 2033 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA COMPRISING ADMINISTERING A COMPOSITION ACCORDING TO CLAIM 1 OF US 11752106 |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11752106 | Feb. 27, 2033 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA COMPRISING ADMINISTERING A COMPOSITION ACCORDING TO CLAIM 1 OF US 11752106 |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11752106 | Feb. 27, 2033 | TREATMENT OF CF WITH A COMP. OF CLAIM 1 OF US 11752106 IN CF PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 12214083 | Feb. 27, 2033 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA COMPRISING ADMINISTERING A COMPOSITION ACCORDING TO CLAIM 1 OF US 12,214,083 |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 12214083 | Feb. 27, 2033 | TREATMENT OF CF WITH A COMP. OF CLAIM 1 OF US 12214083 IN CF PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 10272046 | Feb. 27, 2033 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA COMPRISING ADMINISTERING A COMPOSITION ACCORDING TO CLAIM 1 OF US 10272046 |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 10272046 | Feb. 27, 2033 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA COMPRISING ADMINISTERING A COMPOSITION ACCORDING TO CLAIM 1 OF US 10272046 |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 10272046 | Feb. 27, 2033 | TREATMENT OF CF WITH A COMP. OF CLAIM 1 OF US 10272046 IN CF PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11147770 | Feb. 27, 2033 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA COMPRISING ADMINISTERING A COMPOSITION ACCORDING TO CLAIM 1 OF US 11147770 |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11147770 | Feb. 27, 2033 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA COMPRISING ADMINISTERING A COMPOSITION ACCORDING TO CLAIM 1 OF US 11147770 |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11147770 | Feb. 27, 2033 | TREATMENT OF CF WITH A COMP. OF CLAIM 1 OF US 11147770 IN CF PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11752106 | Feb. 27, 2033 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA COMPRISING ADMINISTERING A COMPOSITION ACCORDING TO CLAIM 1 OF US 11752106 |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11752106 | Feb. 27, 2033 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA COMPRISING ADMINISTERING A COMPOSITION ACCORDING TO CLAIM 1 OF US 11752106 |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11752106 | Feb. 27, 2033 | TREATMENT OF CF WITH A COMP. OF CLAIM 1 OF US 11752106 IN CF PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 12214083 | Feb. 27, 2033 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA COMPRISING ADMINISTERING A COMPOSITION ACCORDING TO CLAIM 1 OF US 12,214,083 |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 12214083 | Feb. 27, 2033 | TREATMENT OF CF WITH A COMP. OF CLAIM 1 OF US 12214083 IN CF PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 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 |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 10758534 | Oct. 6, 2035 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 10758534 | Oct. 6, 2035 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 10758534 | Oct. 6, 2035 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 10758534 | Oct. 6, 2035 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 11426407 | Oct. 6, 2035 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH A COMPOUND OF CLAIM 1 OR COMPOSITION OF CLAIM 29 OF US11426407 |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 11426407 | Oct. 6, 2035 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 11426407 | Oct. 6, 2035 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOUND OF CLAIM 1 OR COMPOSITION OF CLAIM 29 OF US11426407 |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 10758534 | Oct. 6, 2035 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 10758534 | Oct. 6, 2035 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 10758534 | Oct. 6, 2035 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 11426407 | Oct. 6, 2035 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH A COMPOUND OF CLAIM 1 OR COMPOSITION OF CLAIM 29 OF US11426407 |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 11426407 | Oct. 6, 2035 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 11426407 | Oct. 6, 2035 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOUND OF CLAIM 1 OR COMPOSITION OF CLAIM 29 OF US11426407 |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 10758534 | Oct. 6, 2035 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 10758534 | Oct. 6, 2035 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 10758534 | Oct. 6, 2035 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11426407 | Oct. 6, 2035 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH A COMPOUND OF CLAIM 1 OR COMPOSITION OF CLAIM 29 OF US 11426407 |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11426407 | Oct. 6, 2035 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11426407 | Oct. 6, 2035 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOUND OF CLAIM 1 OR COMPOSITION OF CLAIM 29 OF US 11426407 |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 10758534 | Oct. 6, 2035 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 10758534 | Oct. 6, 2035 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 10758534 | Oct. 6, 2035 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11426407 | Oct. 6, 2035 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH A COMPOUND OF CLAIM 1 OR COMPOSITION OF CLAIM 29 OF US 11426407 |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11426407 | Oct. 6, 2035 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11426407 | Oct. 6, 2035 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOUND OF CLAIM 1 OR COMPOSITION OF CLAIM 29 OF US 11426407 |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 10793547 | Dec. 8, 2037 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 10793547 | Dec. 8, 2037 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 10793547 | Dec. 8, 2037 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 10793547 | Dec. 8, 2037 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 11179367 | Dec. 8, 2037 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US11179367 |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 11179367 | Dec. 8, 2037 | TREATMENT OF CF WITH A COMP. OF CLAIM 1 OF US 11179367 IN CF PATIENTS AGED ≥6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 11179367 | Dec. 8, 2037 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOSITION ACCORDING TO AT LEAST ONE OF CLAIMS 1-9 OF US11179367 |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 11517564 | Dec. 8, 2037 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA BY ADMINISTERING DAILY ELX (200 MG); TEZ; AND IVA |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 11517564 | Dec. 8, 2037 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 11517564 | Dec. 8, 2037 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA BY ADMINISTERING DAILY ELX (200 MG OR 100 MG); TEZ; AND IVA |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 10793547 | Dec. 8, 2037 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 10793547 | Dec. 8, 2037 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 10793547 | Dec. 8, 2037 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 11179367 | Dec. 8, 2037 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US11179367 |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 11179367 | Dec. 8, 2037 | TREATMENT OF CF WITH A COMP. OF CLAIM 1 OF US 11179367 IN CF PATIENTS AGED ≥6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 11179367 | Dec. 8, 2037 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOSITION ACCORDING TO AT LEAST ONE OF CLAIMS 1-9 OF US11179367 |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 11517564 | Dec. 8, 2037 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA BY ADMINISTERING DAILY ELX (100 MG); TEZ; AND IVA |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 11517564 | Dec. 8, 2037 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 11517564 | Dec. 8, 2037 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA BY ADMINISTERING DAILY ELX (200 MG OR 100 MG); TEZ; AND IVA |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 10793547 | Dec. 8, 2037 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 10793547 | Dec. 8, 2037 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 10793547 | Dec. 8, 2037 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11179367 | Dec. 8, 2037 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US11179367 |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11179367 | Dec. 8, 2037 | TREATMENT OF CF WITH A COMP. OF CLAIM 1 OF US 11179367 IN CF PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11179367 | Dec. 8, 2037 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOSITION ACCORDING TO ANY ONE OF CLAIMS 1-3 AND 7-9 OF US11179367 |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11517564 | Dec. 8, 2037 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA BY ADMINISTERING DAILY ELX (100 MG OR 80 MG); TEZ; AND IVA |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11517564 | Dec. 8, 2037 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11517564 | Dec. 8, 2037 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA BY ADMINISTERING DAILY ELX (100 MG OR 80 MG); TEZ; AND IVA |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 10793547 | Dec. 8, 2037 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 10793547 | Dec. 8, 2037 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 10793547 | Dec. 8, 2037 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11179367 | Dec. 8, 2037 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US11179367 |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11179367 | Dec. 8, 2037 | TREATMENT OF CF WITH A COMP. OF CLAIM 1 OF US 11179367 IN CF PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11179367 | Dec. 8, 2037 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOSITION ACCORDING TO ANY ONE OF CLAIMS 1-3 AND 7-9 OF US11179367 |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11517564 | Dec. 8, 2037 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA BY ADMINISTERING DAILY ELX (100 MG OR 80 MG); TEZ; AND IVA |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11517564 | Dec. 8, 2037 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 11517564 | Dec. 8, 2037 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA BY ADMINISTERING DAILY ELX (100 MG OR 80 MG); TEZ; AND IVA |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 12350262 | July 17, 2038 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA BY ADMINISTERING DAILY ELX/TEZ/IVA (200 MG/100 MG/150 MG) + IVA (150 MG) |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 12350262 | July 17, 2038 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 12350262 | July 17, 2038 | TREATMENT OF CF IN PATIENTS AGED 6 TO <12 YEARS OLD WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA BY ADMINISTERING DAILY ELX/TEZ/IVA (100 MG/50 MG/75 MG) + IVA (75 MG) |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 12350262 | July 17, 2038 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 12350262 | July 17, 2038 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS OLD WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA BY ADMINISTERING DAILY ELX/TEZ/IVA (100 MG/50 MG/75 MG) + IVA (75 MG) |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | 12350262 | July 17, 2038 | TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A CF DIAGNOSIS AND AT LEAST ONE VARIANT IN THE CFTR GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | April 26, 2026 | NEW PRODUCT |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | April 26, 2026 | NEW PRODUCT |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | Oct. 21, 2026 | INDICATED FOR THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | Oct. 21, 2026 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | Dec. 20, 2027 | LABELING CHANGES BASED UPON RESULTS FROM STUDY 124 (TRIAL 5) |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | Dec. 20, 2027 | LABELING CHANGES BASED UPON RESULTS FROM STUDY 124 (TRIAL 5) |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | Dec. 20, 2027 | LABELING CHANGES BASED UPON RESULTS FROM STUDY 124 (TRIAL 5) |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | Dec. 21, 2027 | TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE A MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | Dec. 21, 2027 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
| 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 |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | April 26, 2030 | TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 2 YEARS TO LESS THAN 6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | April 26, 2030 | TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 2 YEARS TO LESS THAN 6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | Dec. 20, 2031 | TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 2 YEARS AND OLDER WHO HAVE ONE OF THE ADDITIONAL MUTATIONS IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT IS RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA AND IDENTIFIED IN THE APPROVAL ON DECEMBER 20,2024 |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | Dec. 20, 2031 | TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 2 YEARS AND OLDER WHO HAVE ONE OF THE ADDITIONAL MUTATIONS IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT IS RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA AND IDENTIFIED IN THE APPROVAL ON DECEMBER 20,2024 |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | Dec. 20, 2031 | TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 2 YEARS AND OLDER WHO HAVE ONE OF THE ADDITIONAL MUTATIONS IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT IS RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA AND IDENTIFIED IN THE APPROVAL ON DECEMBER 20,2024 |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | Dec. 20, 2031 | TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 2 YEARS AND OLDER WHO HAVE ONE OF THE ADDITIONAL MUTATIONS IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT IS RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA AND IDENTIFIED IN THE APPROVAL ON DECEMBER 20,2024 |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | March 27, 2033 | TREATMENT OF CYSTIC FIBROSIS (CF) IN ADULT AND PEDIATRIC PATIENTS AGED 2 YEARS AND OLDER WHO HAVE A CLINICAL DIAGNOSIS OF CF AND WHO HAVE AT LEAST ONE VARIANT IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN AND IDENTIFIED IN THE APPROVAL ON MARCH 27, 2026, EXCLUDING PATIENTS COVERED BY PREVIOUS APPROVALS FOR TRIKAFTA |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | March 27, 2033 | TREATMENT OF CYSTIC FIBROSIS (CF) IN ADULT AND PEDIATRIC PATIENTS AGED 2 YEARS AND OLDER WHO HAVE A CLINICAL DIAGNOSIS OF CF AND WHO HAVE AT LEAST ONE VARIANT IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN AND IDENTIFIED IN THE APPROVAL ON MARCH 27, 2026, EXCLUDING PATIENTS COVERED BY PREVIOUS APPROVALS FOR TRIKAFTA |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | March 27, 2033 | TREATMENT OF CYSTIC FIBROSIS (CF) IN ADULT AND PEDIATRIC PATIENTS AGED 2 YEARS AND OLDER WHO HAVE A CLINICAL DIAGNOSIS OF CF AND WHO HAVE AT LEAST ONE VARIANT IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN AND IDENTIFIED IN THE APPROVAL ON MARCH 27, 2026, EXCLUDING PATIENTS COVERED BY PREVIOUS APPROVALS FOR TRIKAFTA |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULE | ORAL | March 27, 2033 | TREATMENT OF CYSTIC FIBROSIS (CF) IN ADULT AND PEDIATRIC PATIENTS AGED 2 YEARS AND OLDER WHO HAVE A CLINICAL DIAGNOSIS OF CF AND WHO HAVE AT LEAST ONE VARIANT IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT IS EITHER RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA OR RESULTS IN PRODUCTION OF CFTR PROTEIN AND IDENTIFIED IN THE APPROVAL ON MARCH 27, 2026, EXCLUDING PATIENTS COVERED BY PREVIOUS APPROVALS FOR TRIKAFTA |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Cystic fibrosis transmembrane conductance regulator | Ion channel | EC50 | 7.15 | IUPHAR | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| 4038884 | VANDF |
| CHEBI:234518 | CHEBI |
| WJX | PDB_CHEM_ID |
| CHEMBL4298128 | ChEMBL_ID |
| D11700 | KEGG_DRUG |
| C000629074 | MESH_SUPPLEMENTAL_RECORD_UI |
| 10552 | IUPHAR_LIGAND_ID |
| DB15444 | DRUGBANK_ID |
| 827070004 | SNOMEDCT_US |
| C5139717 | UMLSCUI |
| 11180 | INN_ID |
| 37631 | MMSL |
| d09420 | MMSL |
| 134587348 | PUBCHEM_CID |
| 018170 | NDDF |
| RRN67GMB0V | UNII |
| 2256951 | RXNORM |
| RRN67GMB0V | INXIGHT DRUGS |
Pharmaceutical products:
None