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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 patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ivacaftor; ivacaftor, tezacaftor has three hundred and forty-three patent family members in thirty-seven countries.
There are three drug master file entries for ivacaftor; ivacaftor, tezacaftor. One supplier is listed for this compound.
Summary for ivacaftor; ivacaftor, tezacaftor
International Patents: | 343 |
US Patents: | 20 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 3 |
Suppliers / Packagers: | 1 |
Clinical Trials: | 29 |
DailyMed Link: | ivacaftor; ivacaftor, tezacaftor at DailyMed |
Recent Clinical Trials for ivacaftor; ivacaftor, tezacaftor
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Children's Hospital Medical Center, Cincinnati | N/A |
University of Nottingham | Phase 2 |
Cystic Fibrosis Trust | Phase 2 |
US Patents and Regulatory Information for ivacaftor; ivacaftor, tezacaftor
International Patents for ivacaftor; ivacaftor, tezacaftor
Country | Patent Number | Estimated Expiration |
---|---|---|
Hungary | E039062 | Start Trial |
Lithuania | 1993360 | Start Trial |
European Patent Office | 2563778 | Start Trial |
Denmark | 2464337 | Start Trial |
Israel | 180224 | Start Trial |
European Patent Office | 2502911 | Start Trial |
Japan | 2015172087 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ivacaftor; ivacaftor, tezacaftor
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1773816 | 92761 | Luxembourg | Start Trial | PRODUCT NAME: N-(5-HYDROXY-2,4-DIERT-BUTYL-PHENYL)-4OXO-1H-QUINOLINE-3-CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; FIRST REGISTRATION: 20120725 |
1773816 | 1590036-8 | Sweden | Start 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 | 15C0045 | France | Start Trial | PRODUCT NAME: IVACAFTOR, OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725 |
1773816 | PA2015028 | Lithuania | Start Trial | PRODUCT NAME: IVACAFTORUM; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002 20120723 |
1773816 | CA 2015 00038 | Denmark | Start Trial | PRODUCT NAME: IVACAFTOR, N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLIN-3-CARBOXAMID ELLER ET FARMACEUTISK ACCEPTABLET SALT DERAF; REG. NO/DATE: EU/1/12/782/001-002 20120723 |
1773816 | C20150028 00162 | Estonia | Start Trial | PRODUCT NAME: IVAKAFTOOR;REG NO/DATE: EU/1/12/782/001-002 25.07.2012 |
1773816 | 132016000022519 | Italy | Start Trial | PRODUCT NAME: IVACAFTOR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(KALYDECO); AUTHORISATION NUMBER(S) AND DATE(S): EU/12/782/001-002, 20120725 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |