Details for New Drug Application (NDA): 218730
✉ Email this page to a colleague
NDA 218730 describes ALYFTREK, which is a drug marketed by Vertex Pharms Inc and is included in one NDA. It is available from one supplier. There are thirty-four patents protecting this drug. Additional details are available on the ALYFTREK profile page.
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.
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: | 34 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 218730
Generic Entry Date for 218730*:
Constraining patent/regulatory exclusivity:
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 | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Apr 9, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | 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 | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | May 17, 2032 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
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 | 218730-001 | Dec 20, 2024 | ⤷ Get Started Free | ⤷ Get Started Free |
| Vertex Pharms Inc | ALYFTREK | deutivacaftor; tezacaftor; vanzacaftor calcium | TABLET;ORAL | 218730-002 | Dec 20, 2024 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription
