deutivacaftor; tezacaftor; vanzacaftor calcium - Profile
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What are the generic drug 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.Deutivacaftor; tezacaftor; vanzacaftor calcium has five hundred and fifty-seven patent family members in fifty-two countries.
Summary for deutivacaftor; tezacaftor; vanzacaftor calcium
| International Patents: | 557 |
| US Patents: | 33 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for deutivacaftor; tezacaftor; vanzacaftor calcium |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for deutivacaftor; tezacaftor; vanzacaftor calcium
Generic Entry Date for deutivacaftor; tezacaftor; vanzacaftor calcium*:
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.
US Patents and Regulatory Information for deutivacaftor; tezacaftor; vanzacaftor calcium
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 | 218730-001 | Dec 20, 2024 | 8,629,162 | ⤷ Start Trial |
| Vertex Pharms Inc | ALYFTREK | deutivacaftor; tezacaftor; vanzacaftor calcium | TABLET;ORAL | 218730-002 | 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 | |
| China | 101460489 | ⤷ Start Trial | |
| China | 103254177 | ⤷ Start Trial | |
| Cyprus | 1116979 | ⤷ 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 |
|---|---|---|---|---|
| 2826776 | 13/2021 | Austria | ⤷ Start Trial | PRODUCT NAME: KOMBINATION VON (A) (R)-1-(2,2-DIFLUORBENZO(D)(1,3)DIOXOL-5-YL)-N-(1-(2,3-DIHYDROXYPROPYL)-6-FLUOR-2-(1-HYDROXY-2-METHYLPROPAN-2-YL)-1H-INDOL-5-YL) CYCLOPROPANCARBOXAMID UND (B) N-(5-HYDROXY-2,4-DI-TERT-BUTYLPHENYL)-4-OXO-1H-CHINOLIN-3-CARBOXAMID; REGISTRATION NO/DATE: EU/1/18/1306 (MITTEILUNG) 20181106 |
| 1773816 | C 2015 027 | Romania | ⤷ Start Trial | PRODUCT NAME: IVACAFTOR SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIAN-(5-HIDROXI-2,4-DITERT-BUTIL-FENIL)-4-OXO-1H-CHINOLIN-3-CARBOXAMIDA SAU O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/12/782/001, EU/1/12/782/002; DATE OF NATIONAL AUTHORISATION: 20120723; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/782/001, EU/1/12/782/002; DATE OF FIRST AUTHORISATION IN EEA: 20120723 |
| 2826776 | LUC00207 | Luxembourg | ⤷ Start Trial | PRODUCT NAME: A COMBINATION OF (A) (R)-1-(2,2-DIFLUOROBENZO(D)(1,3)DIOXOL-5-YL)-N-(1-(2,3-DIHYDROXYPROPYL)-6-FLUORO-2-(1-HYDROXY-2-METHYLPROPAN-2-YL)-1H-INDOL-5-YL)CYCLOPROPANECARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND (B) N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/18/1306 20181106 |
| 3752510 | C20253011 | Finland | ⤷ Start Trial | |
| 2826776 | CR 2021 00013 | Denmark | ⤷ Start Trial | PRODUCT NAME: EN KOMBINATION AF (A) (R)-1-(2,2-DIFLUOROBENZO(D)(1,3)DIOXOL-5-YL)-N-(1-(2,3-DIHYDROXYPROPYL)-6-FLUORO-2-(1-HYDROXY-2-METHYLPROPAN-2-YL)-1H-INDOL-5-YL)CYCLOPROPANECARBOXAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG (B) ....; REG. NO/DATE: EU/1/18/1306 20181106 |
| 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 |
| 2826776 | 132021000000062 | Italy | ⤷ Start Trial | PRODUCT NAME: UNA COMBINAZIONE DI (A) TEZACAFTOR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E (B) IVACAFTOR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(SYMKEVI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1306, 20181106 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
