ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR - Generic Drug Details
✉ Email this page to a colleague
What are the generic sources for elexacaftor, ivacaftor, tezacaftor; ivacaftor and what is the scope of patent protection?
Elexacaftor, ivacaftor, tezacaftor; ivacaftor
is the generic ingredient in one branded drug marketed by Vertex Pharms Inc and is included in two NDAs. There are thirty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Elexacaftor, ivacaftor, tezacaftor; ivacaftor has four hundred and ninety-four patent family members in forty-four countries.
One supplier is listed for this compound.
Summary for ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
International Patents: | 494 |
US Patents: | 32 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 21 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR |
DailyMed Link: | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Generic Entry Dates for ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, TABLET;ORAL |
Generic Entry Dates for ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR*:
Constraining patent/regulatory exclusivity:
Dosage:
GRANULES;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 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
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 |
See all ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR clinical trials
US Patents and Regulatory Information for ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
International Patents for ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Israel | 213155 | מאפפנני הובלת קסטות מקושרות atp ותהליכים לייצורם (Modulators of atp-binding cassette transporters and processes for the preparation of the same) | ⤷ Try a Trial |
European Patent Office | 2502902 | Modulateurs de transporteurs de cassette de liaison a l ́ATP (Modulators of ATP-binding cassette transporters) | ⤷ Try a Trial |
Luxembourg | 92761 | ⤷ Try a Trial | |
Lithuania | 3345625 | ⤷ Try a Trial | |
Australia | 2016208341 | Solid forms of (R)-1(2,2-difluorobenzo[d][1,3]dioxol-5-yl)-N-(1-(2,3- dihyderoxypropyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl) cyclopropanecarboxamide | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2013130669 | ⤷ Try a Trial | |
Mexico | 366161 | COMPOSICION FARMACEUTICA Y SU ADMINISTRACION. (PHARMACEUTICAL COMPOSITION AND ADMINISTRATIONS THEREOF.) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 |
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 |