AI ASSISTANT
Ask DrugCentral
Explore drug information in your own words.
Type a question in the search bar above to get started. Each question is answered independently.
Try a sample question
Select a question to fill the search bar, then submit it or edit it first.
AI can make mistakes. Verify answers against the original sources before relying on them.
deutivacaftor 🐶 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 | 5848 | 1413431-07-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
ALYFTREK is a combination of vanzacaftor, tezacaftor, and deutivacaftor that was approved for the treatment of cystic fibrosis. Vanzacaftor and tezacaftor bind to different sites on the CFTR protein and have an additive effect in facilitating the cellular processing and trafficking of select mutant forms of CFTR (including F508del-CFTR) to increase the amount of CFTR protein delivered to the cell surface compared to either molecule alone. Deutivacaftor potentiates the channel open probability (or gating) of the CFTR protein at the cell surface.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 20, 2024 | FDA | Vertex Pharmaceuticals | |
| June 30, 2025 | EMA | Vertex Pharmaceuticals (Ireland) Limited |
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 | R07AX33 | RESPIRATORY SYSTEM OTHER RESPIRATORY SYSTEM PRODUCTS OTHER RESPIRATORY SYSTEM PRODUCTS Other respiratory system products |
| MeSH PA | D049990 | Membrane Transport Modulators |
| MeSH PA | D065101 | Chloride Channel Agonists |
| FDA MoA | N0000184145 | Chloride Channel Activation Potentiators |
| FDA EPC | N0000184146 | Cystic Fibrosis Transmembrane Conductance Regulator Potentiator |
| FDA MoA | N0000185503 | P-Glycoprotein Inhibitors |
| FDA MoA | N0000185504 | Cytochrome P450 2C9 Inhibitors |
| FDA MoA | N0000190113 | Breast Cancer Resistance Protein Inhibitors |
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
None
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 8354427 | July 6, 2026 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AN R117H MUTATION IN THE CFTR GENE WITH VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR |
| 50MG;20MG;EQ 4MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 8354427 | July 6, 2026 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AN R117H MUTATION IN THE CFTR GENE WITH VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 9670163 | Dec. 28, 2026 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH A SOLID PHARMACEUTICAL COMPOSITION COMPRISING VNZ, TEZ, AMORPHOUS D-IVA, AND <30% CRYSTALLINE D-IVA |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 9670163 | Dec. 28, 2026 | TREATMENT OF CF WITH VNZ/TEZ AND A COMP. OF CLAIM 1 OF US9670163 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 |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 9931334 | Dec. 28, 2026 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH A SOLID PHARMACEUTICAL COMPOSITION COMPRISING VNZ, TEZ, AMORPHOUS D-IVA, AND <30% CRYSTALLINE D-IVA |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 9931334 | Dec. 28, 2026 | TREATMENT OF CF WITH VNZ/TEZ AND A COMP. RECITED IN CLAIM 1 OF US9931334 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;20MG;EQ 4MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 9670163 | Dec. 28, 2026 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH A SOLID PHARMACEUTICAL COMPOSITION COMPRISING VNZ, TEZ, AMORPHOUS D-IVA, AND <30% CRYSTALLINE D-IVA |
| 50MG;20MG;EQ 4MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 9670163 | Dec. 28, 2026 | TREATMENT OF CF WITH VNZ/TEZ AND A COMP. OF CLAIM 1 OF US9670163 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;20MG;EQ 4MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 9931334 | Dec. 28, 2026 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH A SOLID PHARMACEUTICAL COMPOSITION COMPRISING VNZ, TEZ, AMORPHOUS D-IVA, AND <30% CRYSTALLINE D-IVA |
| 50MG;20MG;EQ 4MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 9931334 | Dec. 28, 2026 | TREATMENT OF CF WITH VNZ/TEZ AND A COMP. RECITED IN CLAIM 1 OF US9931334 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 |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | 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 VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 10239867 | April 9, 2027 | TREATMENT OF CF WITH VNZ, TEZ, D-IVA 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 |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | 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 OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 11639347 | April 9, 2027 | TREATMENT OF CF WITH VNZ, TEZ, D-IVA 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 |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 11639347 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 9974781 | April 9, 2027 | TREATMENT OF CF WITH VNZ, TEZ, AND D-IVA 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 |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | 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 OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR |
| 50MG;20MG;EQ 4MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | 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 VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR |
| 50MG;20MG;EQ 4MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 10239867 | April 9, 2027 | TREATMENT OF CF WITH VNZ, TEZ, D-IVA 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;20MG;EQ 4MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | 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 OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR |
| 50MG;20MG;EQ 4MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 11639347 | April 9, 2027 | TREATMENT OF CF WITH VNZ, TEZ, D-IVA 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;20MG;EQ 4MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 11639347 | April 9, 2027 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR |
| 50MG;20MG;EQ 4MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 9974781 | April 9, 2027 | TREATMENT OF CF WITH VNZ, TEZ, AND D-IVA 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;20MG;EQ 4MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | 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 OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 8598181 | May 1, 2027 | TREATMENT OF CF WITH VNZ, TEZ, AND D-IVA 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 |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | 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 OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR |
| 50MG;20MG;EQ 4MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 8598181 | May 1, 2027 | TREATMENT OF CF WITH VNZ, TEZ, AND D-IVA 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;20MG;EQ 4MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | 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 OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 8324242 | Aug. 5, 2027 | TREATMENT OF CF WITH VNZ, TEZ, D-IVA 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 |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | 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 OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR |
| 50MG;20MG;EQ 4MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 8324242 | Aug. 5, 2027 | TREATMENT OF CF WITH VNZ, TEZ, D-IVA 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;20MG;EQ 4MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | 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 OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 8415387 | Nov. 12, 2027 | TREATMENT OF CF WITH VNZ, TEZ, AND D-IVA 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 |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | 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 OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR |
| 50MG;20MG;EQ 4MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 8415387 | Nov. 12, 2027 | TREATMENT OF CF WITH VNZ, TEZ, AND D-IVA 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;20MG;EQ 4MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | 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 OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 11564916 | Aug. 13, 2029 | TREATMENT OF CF WITH VNZ/TEZ AND A COMP. RECITED IN CLAIM 1 OF US11564916 IN CF PATIENTS AGED ≥6 Y 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 |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 11564916 | Aug. 13, 2029 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US11564916, VNZ, AND TEZ |
| 50MG;20MG;EQ 4MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 11564916 | Aug. 13, 2029 | TREATMENT OF CF WITH VNZ/TEZ AND A COMP. RECITED IN CLAIM 1 OF US11564916 IN CF PATIENTS AGED ≥6 Y 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;20MG;EQ 4MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 11564916 | Aug. 13, 2029 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US11564916, VNZ, AND TEZ |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 10081621 | March 25, 2031 | TREATMENT OF CF WITH VNZ, D-IVA, AND A COMP. RECITED IN CLAIM 8 OF 10081621 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 |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | 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 OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VNZ, D-IVA, AND A COMPOSITION ACCORDING TO CLAIM 1 OF US10081621 |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 11578062 | March 25, 2031 | TREATMENT OF CF WITH VNZ, D-IVA, AND A COMP. RECITED IN CLAIM 13 OF 11578062 IN CF PATIENTS AGED ≥6 Y 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 |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 11578062 | March 25, 2031 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VANZACAFTOR, DEUTIVACAFTOR, AND A SOLID DISPERSION ACCORDING TO CLAIM 1 OF US 11,578,062 |
| 50MG;20MG;EQ 4MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 10081621 | March 25, 2031 | TREATMENT OF CF WITH VNZ, D-IVA, AND A COMP. RECITED IN CLAIM 8 OF 10081621 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;20MG;EQ 4MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | 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 OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VNZ, D-IVA, AND A COMPOSITION ACCORDING TO CLAIM 1 OF US10081621 |
| 50MG;20MG;EQ 4MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 11578062 | March 25, 2031 | TREATMENT OF CF WITH VNZ, D-IVA, AND A COMP. RECITED IN CLAIM 13 OF 11578062 IN CF PATIENTS AGED ≥6 Y 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;20MG;EQ 4MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 11578062 | March 25, 2031 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VANZACAFTOR, DEUTIVACAFTOR, AND A SOLID DISPERSION ACCORDING TO CLAIM 1 OF US 11,578,062 |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 9181192 | May 17, 2032 | TREATING CF WITH VNZ/TEZ AND A D-IVA COMP. WITH 90%+ ISOTOPIC ENRICHMENT FOR EACH D ATOM 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 PRODUCES CFTR PROTEIN |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 9181192 | May 17, 2032 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH A COMPOSITION COMPRISING VNZ, TEZ, AND D-IVA WITH AT LEAST 90% ISOTOPIC ENRICHMENT FOR EACH DEUTERIUM ATOM |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 9512079 | May 17, 2032 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF VNZ, TEZ, AND A COMPOSITION ACCORDING TO CLAIM 3 OF US 9,512,079 |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 9512079 | May 17, 2032 | TREATMENT OF CF WITH VNZ/TEZ AND A COMP. OF CLAIM 3 OF US9512079 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;20MG;EQ 4MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 9181192 | May 17, 2032 | TREATING CF WITH VNZ/TEZ AND A D-IVA COMP. WITH 90%+ ISOTOPIC ENRICHMENT FOR EACH D ATOM 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 PRODUCES CFTR PROTEIN |
| 50MG;20MG;EQ 4MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 9181192 | May 17, 2032 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH A COMPOSITION COMPRISING VNZ, TEZ, AND D-IVA WITH AT LEAST 90% ISOTOPIC ENRICHMENT FOR EACH DEUTERIUM ATOM |
| 50MG;20MG;EQ 4MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 9512079 | May 17, 2032 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF VNZ, TEZ, AND A COMPOSITION ACCORDING TO CLAIM 3 OF US 9,512,079 |
| 50MG;20MG;EQ 4MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 9512079 | May 17, 2032 | TREATMENT OF CF WITH VNZ/TEZ AND A COMP. OF CLAIM 3 OF US9512079 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 |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 10058546 | July 15, 2033 | TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WITH AT LEAST ONE F508DEL OR G551D AND AN R117H, A455E, 2789+5G->A, OR 3849+10KBC->T CFTR MUTATION, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF US10058546 CLAIM 1 FURTHER COMPRISING VNZ |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | 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, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF US 9,012,496 FURTHER COMPRISING VNZ |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 10206877 | April 14, 2035 | TREATMENT OF CF WITH VNZ AND A COMP. OF CLAIM 1 OF US10206877 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 |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 10206877 | April 14, 2035 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VNZ AND A COMPOSITION ACCORDING TO CLAIM 1 OF US10206877 |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 11951212 | April 14, 2035 | TREATMENT OF CF WITH VNZ AND A COMP. OF CLAIM 1 OF US11951212 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 |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 11951212 | April 14, 2035 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VNZ AND A COMPOSITION ACCORDING TO CLAIM 1 OF US11951212 |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 11866450 | Feb. 14, 2039 | TREATMENT OF CF WITH VNZ, TEZ, AND D-IVA 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 |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 11866450 | Feb. 14, 2039 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR |
| 50MG;20MG;EQ 4MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 11866450 | Feb. 14, 2039 | TREATMENT OF CF WITH VNZ, TEZ, AND D-IVA 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;20MG;EQ 4MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 11866450 | Feb. 14, 2039 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 11873300 | Aug. 13, 2040 | TREATMENT OF CF WITH VNZ CA SALT HYDRATE FORM D, TEZ, AND D-IVA 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 |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 11873300 | Aug. 13, 2040 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VANZACAFTOR CALCIUM SALT HYDRATE FORM D, TEZACAFTOR, AND DEUTIVACAFTOR |
| 50MG;20MG;EQ 4MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 11873300 | Aug. 13, 2040 | TREATMENT OF CF WITH VNZ CA SALT HYDRATE FORM D, TEZ, AND D-IVA 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;20MG;EQ 4MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 11873300 | Aug. 13, 2040 | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VANZACAFTOR CALCIUM SALT HYDRATE FORM D, TEZACAFTOR, AND DEUTIVACAFTOR |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 12186306 | Jan. 10, 2043 | TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH 21.4 MG OF VNZ CALCIUM SALT HYDRATE FORM D, 100 MG OF TEZ, AND 250 MG OF D-IVA DAILY |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | 12186306 | Jan. 10, 2043 | TREATMENT OF CF WITH VNZ CA SALT HYDRATE FORM D/TEZ/D-IVA (21.24/100/250 MG) IN CF PATIENTS AGED ≥6 Y 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 |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | Dec. 20, 2029 | NEW CHEMICAL ENTITY |
| 50MG;20MG;EQ 4MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | Dec. 20, 2029 | NEW CHEMICAL ENTITY |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | Dec. 20, 2031 | TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS 6 YEARS OF AGE AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE |
| 50MG;20MG;EQ 4MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | Dec. 20, 2031 | TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS 6 YEARS OF AGE AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE |
| 125MG;50MG;EQ 10MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | March 27, 2033 | TREATMENT OF CYSTIC FIBROSIS (CF) IN ADULT AND PEDIATRIC PATIENTS 6 YEARS OF AGE 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 IS IDENTIFIED IN THE APPROVAL ON MARCH 27, 2026, EXCLUDING PATIENTS COVERED BY THE PREVIOUS APPROVAL FOR ALYFTREK ON DECEMBER 20, 2024 |
| 50MG;20MG;EQ 4MG BASE | ALYFTREK | VERTEX PHARMS INC | N218730 | Dec. 20, 2024 | RX | TABLET | ORAL | March 27, 2033 | TREATMENT OF CYSTIC FIBROSIS (CF) IN ADULT AND PEDIATRIC PATIENTS 6 YEARS OF AGE 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 IS IDENTIFIED IN THE APPROVAL ON MARCH 27, 2026, EXCLUDING PATIENTS COVERED BY THE PREVIOUS APPROVAL FOR ALYFTREK ON DECEMBER 20, 2024 |
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 | ACTIVATOR | EC50 | 6.59 | IUPHAR | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| CHEMBL4297603 | ChEMBL_ID |
| C545203 | MESH_SUPPLEMENTAL_RECORD_UI |
| DB15141 | DRUGBANK_ID |
| 4043969 | VANDF |
| C5139842 | UMLSCUI |
| CHEBI:757077 | CHEBI |
| 10704 | INN_ID |
| 71470491 | PUBCHEM_CID |
| 13695 | IUPHAR_LIGAND_ID |
| SHA6U5FJZL | UNII |
| 2701430 | RXNORM |
| 45314611000001103 | SNOMEDCT_US |
| D11423 | KEGG_DRUG |
| 43615 | MMSL |
| d10241 | MMSL |
| 019955 | NDDF |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| ALYFTREK | HUMAN PRESCRIPTION DRUG LABEL | 3 | 51167-121 | TABLET, FILM COATED | 125 mg | ORAL | NDA | 33 sections |
| ALYFTREK | HUMAN PRESCRIPTION DRUG LABEL | 3 | 51167-135 | TABLET, FILM COATED | 50 mg | ORAL | NDA | 33 sections |