Ivacaftor; ivacaftor, tezacaftor - Generic Drug Details
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What are the generic sources for ivacaftor; ivacaftor, tezacaftor and what is the scope of patent protection?
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 |
|---|---|
| University of North Carolina, Chapel Hill | Phase 4 |
| Chiesi USA, Inc. | Phase 4 |
| Emory University | Phase 4 |
US Patents and Regulatory Information for ivacaftor; ivacaftor, tezacaftor
International Patents for ivacaftor; ivacaftor, tezacaftor
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Denmark | 3219705 | ⤷ Try a Trial | |
| Australia | 2009282419 | Pharmaceutical composition and administrations thereof | ⤷ Try a Trial |
| Portugal | 2464337 | ⤷ Try a Trial | |
| Turkey | 201809684 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 2006002421 | ⤷ Try a Trial | |
| Poland | 3091011 | ⤷ Try a Trial | |
| European Patent Office | 2502911 | Modulateurs de transporteurs de cassette de liaison à l ́ATP (Modulators of ATP-binding cassette 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 |
|---|---|---|---|---|
| 2826776 | C202130026 | Spain | ⤷ Try a Trial | PRODUCT NAME: UNA COMBINACION DE (A) (R)-1-(2,2-DIFLUOROBENZO(D)(1,3)DIOXOL-5-IL)-N-(1-(2,3-DIHIDROXIPROPIL)-6-FLUORO-2-(1-HIDROXI-2-METILPROPAN-2-IL)-1H-INDOL-5-IL)CICLOPROPANOCARBOXAMIDA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO Y(B) N-(5-HIDROXI-2,4-DITERT-BUTIL-FENIL)-4-OXO-1HQUINOLIN-3-CARBOXAMIDA O UNA SALFARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1306; DATE OF AUTHORISATION: 20181031; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1306; DATE OF FIRST AUTHORISATION IN EEA: 20181031 |
| 1773816 | C300748 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725 |
| 1773816 | PA2015028,C1773816 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: IVAKAFTORAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002, 0120723 |
| 2826776 | LUC00207 | Luxembourg | ⤷ Try a 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 |
| 1773816 | C01773816/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: IVACAFTOR; REGISTRATION NO/DATE: SWISSMEDIC 62686 13.01.2014 |
| 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 | C20210011 00330 | Estonia | ⤷ Try a Trial | PRODUCT NAME: TESAKAFTOOR/IVAKAFTOOR;REG NO/DATE: EU/1/18/1306 06.11.2018 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
