DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM - Generic Drug Details
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What are the generic sources for deutivacaftor; tezacaftor; vanzacaftor calcium and what is the scope of patent protection?
Deutivacaftor; tezacaftor; vanzacaftor calcium
is the generic ingredient in one branded drug marketed by Vertex Pharms Inc and is included in one NDA. There are thirty-three patents protecting this compound. Additional information is available in the individual branded drug profile pages.One supplier is listed for this compound.
Summary for DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
| International Patents: | 560 |
| US Patents: | 33 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM |
| DailyMed Link: | DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
Generic Entry Date for DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM*:
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 DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Vertex Pharms Inc | ALYFTREK | deutivacaftor; tezacaftor; vanzacaftor calcium | TABLET;ORAL | 218730-002 | Dec 20, 2024 | RX | Yes | Yes | 8,623,905 | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Vertex Pharms Inc | ALYFTREK | deutivacaftor; tezacaftor; vanzacaftor calcium | TABLET;ORAL | 218730-001 | Dec 20, 2024 | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Vertex Pharms Inc | ALYFTREK | deutivacaftor; tezacaftor; vanzacaftor calcium | TABLET;ORAL | 218730-001 | Dec 20, 2024 | RX | Yes | No | 7,495,103 | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Vertex Pharms Inc | ALYFTREK | deutivacaftor; tezacaftor; vanzacaftor calcium | TABLET;ORAL | 218730-001 | Dec 20, 2024 | RX | Yes | No | 11,578,062 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
| 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 | 8,629,162 | ⤷ Start Trial |
| 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 | 218730-001 | Dec 20, 2024 | 8,629,162 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2007235260 | ⤷ Start Trial | |
| Brazil | PI0710965 | ⤷ Start Trial | |
| Canada | 2648719 | ⤷ Start Trial | |
| Canada | 2869945 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3752510 | 2025C/547 | Belgium | ⤷ Start Trial | PRODUCT NAME: VANZACAFTOR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, BIJ VOORKEUR EEN CALCIUMZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/25/1943 20250701 |
| 1773816 | 2015C/040 | Belgium | ⤷ Start Trial | PRODUCT NAME: N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/12/782/001-002 20120725 |
| 1773816 | CR 2015 00038 | Denmark | ⤷ Start Trial | PRODUCT NAME: N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLIN-3-CARBOXAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/12/782/001-002 20120725 |
| 1773816 | 35/2015 | Austria | ⤷ Start Trial | PRODUCT NAME: N-(5-HYDROXY-2,4DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLIN-3-CARBOXAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/782/001, EU/1/12/782/002 (MITTEILUNG) 20120725 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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