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 |
Anatomical Therapeutic Chemical (ATC) Classes for ivacaftor; ivacaftor, tezacaftor
US Patents and Regulatory Information for ivacaftor; ivacaftor, tezacaftor
International Patents for ivacaftor; ivacaftor, tezacaftor
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Slovenia | 3345625 | ⤷ Try a Trial | |
Israel | 288388 | צורות מוצקות של (r)-1(2,2-דיפלואורובנזו[d][3,1]דיאוקסול-5-יל)-n-(1-(3,2-דיהידרוקסיפרופיל)-6-פלואורו-2-(1-הידרוקסי-2-מתילפרופאנ-2-יל)-1h-אינדול-5-יל)ציקלופרופאנקרבוקסאמיד (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 |
Canada | 2794559 | FORMES SOLIDES DE (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 (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 |
Spain | 2882684 | ⤷ Try a Trial | |
Australia | 2010251787 | Modulators of ATP-Binding Cassette Transporters | ⤷ Try a Trial |
Japan | 2013523655 | ⤷ 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 | 21C1018 | France | ⤷ Try a Trial | PRODUCT NAME: TEZACAFTOR ET IVACAFTOR, SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/18/1306 20181106 |
3170818 | C202030042 | Spain | ⤷ Try a Trial | PRODUCT NAME: UNA COMBINACION DE A) LUMACAFTOR Y B) IVACAFTOR; NATIONAL AUTHORISATION NUMBER: EU/1/15/1059; DATE OF AUTHORISATION: 20151119; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1059; DATE OF FIRST AUTHORISATION IN EEA: 20151119 |
1773816 | PA2015028 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: IVACAFTORUM; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002 20120723 |
1773816 | C01773816/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: IVACAFTOR; REGISTRATION NO/DATE: SWISSMEDIC 62686 13.01.2014 |
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 | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |