IVACAFTOR; IVACAFTOR, TEZACAFTOR - Generic Drug Details
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What are the generic drug sources for ivacaftor; ivacaftor, tezacaftor and what is the scope of freedom to operate?
Ivacaftor; ivacaftor, tezacaftor
is the generic ingredient in one branded drug marketed by Vertex Pharms Inc and is included in one NDA. There are twenty-four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ivacaftor; ivacaftor, tezacaftor has four hundred and sixteen patent family members in thirty-nine countries.
One supplier is listed for this compound.
Summary for IVACAFTOR; IVACAFTOR, TEZACAFTOR
International Patents: | 416 |
US Patents: | 24 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 44 |
DailyMed Link: | IVACAFTOR; IVACAFTOR, TEZACAFTOR at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for IVACAFTOR; IVACAFTOR, TEZACAFTOR
Generic Entry Date for IVACAFTOR; IVACAFTOR, TEZACAFTOR*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, 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.
Recent Clinical Trials for IVACAFTOR; IVACAFTOR, TEZACAFTOR
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Chiesi USA, Inc. | Phase 4 |
University of North Carolina, Chapel Hill | Phase 4 |
The Marcus Foundation, Inc. | Phase 4 |
US Patents and Regulatory Information for IVACAFTOR; IVACAFTOR, TEZACAFTOR
International Patents for IVACAFTOR; IVACAFTOR, TEZACAFTOR
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 2502911 | Modulateurs de transporteurs de cassette de liaison à l ́ATP (Modulators of ATP-binding cassette transporters) | ⤷ Try a Trial |
European Patent Office | 3705477 | MODULATEURS DE TRANSPORTEURS DE CASSETTE À LIAISON ATP (MODULATORS OF ATP-BINDING CASSETTE TRANSPORTERS) | ⤷ Try a Trial |
Brazil | PI0710965 | moduladores de transportadores de cassete de ligação de atp | ⤷ Try a Trial |
South Africa | 200700601 | Modulators of atp-binding cassete transporters | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for IVACAFTOR; IVACAFTOR, TEZACAFTOR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1773816 | PA2015028 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: IVACAFTORUM; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002 20120723 |
1773816 | 1590036-8 | Sweden | ⤷ Try a Trial | PRODUCT NAME: N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3- CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/12/782/001 20120725 |
1773816 | CR 2015 00038 | Denmark | ⤷ Try a 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 |
2826776 | 132021000000062 | Italy | ⤷ Try a 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 |