elexacaftor 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| cystic fibrosis transmembrane regulator (CFTR) protein modulators, correctors, and amplifiers | 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 |
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)
None
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 | D065101 | Chloride Channel Agonists |
| MeSH PA | D049990 | Membrane Transport Modulators |
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 | 8629162 | June 24, 2025 | TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELX, TEZ, AND IVA |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 8629162 | June 24, 2025 | TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 8629162 | June 24, 2025 | TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELX, TEZ, AND IVA |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 8629162 | June 24, 2025 | TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELX, TEZ, AND IVA |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 8629162 | June 24, 2025 | TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELX, TEZ, AND IVA |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 8629162 | June 24, 2025 | TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELX, TEZ, AND IVA |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 8354427 | July 6, 2026 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE A R117H MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 8354427 | July 6, 2026 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE ONE F508DEL MUTATION AND ONE R117H MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 8354427 | July 6, 2026 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A R117H MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 8354427 | July 6, 2026 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A R117H MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 8354427 | July 6, 2026 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A R117H MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 8354427 | July 6, 2026 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE A R117H MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 9670163 | Dec. 28, 2026 | TREATMENT OF CF IN PATIENTS 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 9670163 | Dec. 28, 2026 | TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 9670163 | Dec. 28, 2026 | TREATMENT OF CF IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE USING A SOLID COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AMORPHOUS IVACAFTOR, AND LESS THAN ABOUT 30% CRYSTALLINE IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 9931334 | Dec. 28, 2026 | TREATMENT OF CF IN PATIENTS 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 9931334 | Dec. 28, 2026 | TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 9931334 | Dec. 28, 2026 | TREATMENT OF CF IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE USING A SOLID COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AMORPHOUS IVACAFTOR, AND LESS THAN ABOUT 30% CRYSTALLINE IVACAFTOR |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 9670163 | Dec. 28, 2026 | TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 9931334 | Dec. 28, 2026 | TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 9670163 | Dec. 28, 2026 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 9931334 | Dec. 28, 2026 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 9670163 | Dec. 28, 2026 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 9931334 | Dec. 28, 2026 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 10022352 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF A PHARMACEUTICAL COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 10022352 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF A PHARMACEUTICAL COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 10239867 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 10239867 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 10239867 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 11639347 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 9974781 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 9974781 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 9974781 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 10022352 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF A PHARMACEUTICAL COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 10239867 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 11639347 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 9974781 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 10022352 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF A PHARMACEUTICAL COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 10239867 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 11639347 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 9974781 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 10022352 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF A PHARMACEUTICAL COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 10239867 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 11639347 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 9974781 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 8598181 | May 1, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 8598181 | May 1, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 8598181 | May 1, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 8598181 | May 1, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 8598181 | May 1, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 8598181 | May 1, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 8324242 | Aug. 5, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 8324242 | Aug. 5, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 8324242 | Aug. 5, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 8324242 | Aug. 5, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 8324242 | Aug. 5, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 8324242 | Aug. 5, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 8415387 | Nov. 12, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 8415387 | Nov. 12, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 8415387 | Nov. 12, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 8415387 | Nov. 12, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 8415387 | Nov. 12, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 8415387 | Nov. 12, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 11564916 | Aug. 13, 2029 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA BY ADMINISTERING THE COMPOSITION RECITED IN US 11564916 CLAIM 1 |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 11564916 | Aug. 13, 2029 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA BY ADMINISTERING THE COMPOSITION RECITED IN US 11564916 CLAIM 1 |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 11564916 | Aug. 13, 2029 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA COMPRISING ADMINISTERING THE COMPOSITION RECITED IN US 11564916 CLAIM 1 |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 11564916 | Aug. 13, 2029 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA COMPRISING ADMINISTERING THE COMPOSITION RECITED IN US 11564916 CLAIM 1 |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 10081621 | March 25, 2031 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 10081621 |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 10081621 | March 25, 2031 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 10081621 |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 10081621 | March 25, 2031 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 10081621 |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 11578062 | March 25, 2031 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON IN VITRO DATA BY ADMINISTERING ELEXACAFTOR, IVACAFTOR, AND A SOLID DISPERSION OF TEZACAFTOR AND A POLYMER |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 10081621 | March 25, 2031 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 10081621 |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 11578062 | March 25, 2031 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON IN VITRO DATA BY ADMINISTERING ELEXACAFTOR, IVACAFTOR, AND A SOLID DISPERSION OF TEZACAFTOR AND A POLYMER |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 10081621 | March 25, 2031 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 10081621 |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 11578062 | March 25, 2031 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON IN VITRO DATA BY ADMINISTERING ELEXACAFTOR, IVACAFTOR, AND A SOLID DISPERSION OF TEZACAFTOR AND A POLYMER |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 10081621 | March 25, 2031 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 10081621 |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 11578062 | March 25, 2031 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON IN VITRO DATA BY ADMINISTERING ELEXACAFTOR, IVACAFTOR, AND A SOLID DISPERSION OF TEZACAFTOR AND A POLYMER |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 10272046 | Feb. 27, 2033 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA COMPRISING ADMINISTERING A COMPOSITION ACCORDING TO CLAIM 1 OF US 10272046 |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 11147770 | Feb. 27, 2033 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA COMPRISING ADMINISTERING A COMPOSITION ACCORDING TO CLAIM 1 OF US 11147770 |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 10272046 | Feb. 27, 2033 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA COMPRISING ADMINISTERING A COMPOSITION ACCORDING TO CLAIM 1 OF US 10272046 |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 11147770 | Feb. 27, 2033 | TREATMENT OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA COMPRISING ADMINISTERING A COMPOSITION ACCORDING TO CLAIM 1 OF US 11147770 |
| 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 CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 10758534 | Oct. 6, 2035 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 10758534 | Oct. 6, 2035 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 11426407 | Oct. 6, 2035 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOUND OF CLAIM 1 OR COMPOSITION OF CLAIM 29 OF US11426407 |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 10758534 | Oct. 6, 2035 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 11426407 | Oct. 6, 2035 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOUND OF CLAIM 1 OR COMPOSITION OF CLAIM 29 OF US11426407 |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 10758534 | Oct. 6, 2035 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 11426407 | Oct. 6, 2035 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOUND OF CLAIM 1 OR COMPOSITION OF CLAIM 29 OF US 11426407 |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 10758534 | Oct. 6, 2035 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 11426407 | Oct. 6, 2035 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOUND OF CLAIM 1 OR COMPOSITION OF CLAIM 29 OF US 11426407 |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 10793547 | Dec. 8, 2037 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 10793547 | Dec. 8, 2037 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 10793547 | Dec. 8, 2037 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 11179367 | Dec. 8, 2037 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOSITION ACCORDING TO AT LEAST ONE OF CLAIMS 1-9 OF US11179367 |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | 11517564 | Dec. 8, 2037 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA BY ADMINISTERING DAILY ELX (200 MG OR 100 MG); TEZ; AND IVA |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 10793547 | Dec. 8, 2037 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 11179367 | Dec. 8, 2037 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOSITION ACCORDING TO AT LEAST ONE OF CLAIMS 1-9 OF US11179367 |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | 11517564 | Dec. 8, 2037 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA BY ADMINISTERING DAILY ELX (200 MG OR 100 MG); TEZ; AND IVA |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 10793547 | Dec. 8, 2037 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 11179367 | Dec. 8, 2037 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOSITION ACCORDING TO ANY ONE OF CLAIMS 1-3 AND 7-9 OF US11179367 |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 11517564 | Dec. 8, 2037 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA BY ADMINISTERING DAILY ELX (100 MG OR 80 MG); TEZ; AND IVA |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 10793547 | Dec. 8, 2037 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 11179367 | Dec. 8, 2037 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOSITION ACCORDING TO ANY ONE OF CLAIMS 1-3 AND 7-9 OF US11179367 |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | 11517564 | Dec. 8, 2037 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO <6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA BY ADMINISTERING DAILY ELX (100 MG OR 80 MG); TEZ; AND IVA |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | Feb. 12, 2023 | NEW CHEMICAL ENTITY |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | Feb. 12, 2023 | NEW CHEMICAL ENTITY |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | June 8, 2024 | NEW PATIENT POPULATION |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | June 8, 2024 | NEW PATIENT POPULATION |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | Oct. 21, 2024 | NEW CHEMICAL ENTITY |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | Oct. 21, 2024 | NEW CHEMICAL ENTITY |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | Oct. 21, 2024 | NEW CHEMICAL ENTITY |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | Oct. 21, 2024 | NEW CHEMICAL ENTITY |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | April 26, 2026 | NEW PRODUCT |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | April 26, 2026 | NEW PRODUCT |
| 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 |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | Dec. 21, 2027 | TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE A MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA |
| 100MG,75MG,50MG; 150MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | Oct. 21, 2019 | RX | TABLET | ORAL | June 8, 2028 | FOR THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 6 THROUGH 11 YEARS OLD WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA |
| 50MG,37.5MG,25MG; 75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N212273 | June 8, 2021 | RX | TABLET | ORAL | June 8, 2028 | FOR THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 6 THROUGH 11 YEARS OLD WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA |
| 100MG, 75MG, 50MG;75MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | April 26, 2030 | TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 2 YEARS TO LESS THAN 6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA |
| 80MG, 60MG, 40MG;59.5MG | TRIKAFTA (COPACKAGED) | VERTEX PHARMS INC | N217660 | April 26, 2023 | RX | GRANULES | ORAL | April 26, 2030 | TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 2 YEARS TO LESS THAN 6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA |
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 |
|---|---|
| WJX | PDB_CHEM_ID |
| CHEMBL4298128 | ChEMBL_ID |
| D11700 | KEGG_DRUG |
| C000629074 | MESH_SUPPLEMENTAL_RECORD_UI |
| 10552 | IUPHAR_LIGAND_ID |
| DB15444 | DRUGBANK_ID |
| 018170 | NDDF |
| 827070004 | SNOMEDCT_US |
| 4038884 | VANDF |
| C5139717 | UMLSCUI |
| 11180 | INN_ID |
| 134587348 | PUBCHEM_CID |
| 2256951 | RXNORM |
| 37631 | MMSL |
| d09420 | MMSL |
| RRN67GMB0V | UNII |
Pharmaceutical products:
None