Details for New Drug Application (NDA): 218730
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The generic ingredient in ALYFTREK is deutivacaftor; tezacaftor; vanzacaftor calcium. One supplier is listed for this compound. Additional details are available on the deutivacaftor; tezacaftor; vanzacaftor calcium profile page.
Summary for 218730
| Tradename: | ALYFTREK |
| Applicant: | Vertex Pharms Inc |
| Ingredient: | deutivacaftor; tezacaftor; vanzacaftor calcium |
| Patents: | 33 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 218730
Generic Entry Date for 218730*:
Constraining patent/regulatory exclusivity:
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 Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 218730
Suppliers and Packaging for NDA: 218730
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALYFTREK | deutivacaftor; tezacaftor; vanzacaftor calcium | TABLET;ORAL | 218730 | NDA | Vertex Pharmaceuticals Incorporated | 51167-121 | 51167-121-01 | 4 BLISTER PACK in 1 CARTON (51167-121-01) / 14 TABLET, FILM COATED in 1 BLISTER PACK |
| ALYFTREK | deutivacaftor; tezacaftor; vanzacaftor calcium | TABLET;ORAL | 218730 | NDA | Vertex Pharmaceuticals Incorporated | 51167-135 | 51167-135-01 | 4 BLISTER PACK in 1 CARTON (51167-135-01) / 21 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG;20MG;EQ 4MG BASE | ||||
| Approval Date: | Dec 20, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 20, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Mar 27, 2033 | ||||||||
| Regulatory Exclusivity Use: | 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 | ||||||||
| Regulatory Exclusivity Expiration: | Dec 20, 2031 | ||||||||
| Regulatory Exclusivity Use: | 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 | ||||||||
Expired US Patents for NDA 218730
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Vertex Pharms Inc | ALYFTREK | deutivacaftor; tezacaftor; vanzacaftor calcium | TABLET;ORAL | 218730-002 | Dec 20, 2024 | 8,354,427 | ⤷ Start Trial |
| Vertex Pharms Inc | ALYFTREK | deutivacaftor; tezacaftor; vanzacaftor calcium | TABLET;ORAL | 218730-001 | Dec 20, 2024 | 8,354,427 | ⤷ Start Trial |
| Vertex Pharms Inc | ALYFTREK | deutivacaftor; tezacaftor; vanzacaftor calcium | TABLET;ORAL | 218730-002 | Dec 20, 2024 | 8,629,162 | ⤷ Start Trial |
| Vertex Pharms Inc | ALYFTREK | deutivacaftor; tezacaftor; vanzacaftor calcium | TABLET;ORAL | 218730-001 | Dec 20, 2024 | 8,629,162 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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