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Last Updated: December 13, 2019

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Ivacaftor; lumacaftor - Generic Drug Details

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What are the generic drug sources for ivacaftor; lumacaftor and what is the scope of patent protection?

Ivacaftor; lumacaftor is the generic ingredient in one branded drug marketed by Vertex Pharms Inc and is included in two NDAs. There are seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ivacaftor; lumacaftor has three hundred and thirty-five patent family members in thirty-five countries.

There are three drug master file entries for ivacaftor; lumacaftor. One supplier is listed for this compound.

Summary for ivacaftor; lumacaftor
International Patents:335
US Patents:17
Tradenames:1
Applicants:1
NDAs:2
Drug Master File Entries: 3
Suppliers / Packagers: 1
Clinical Trials: 32
DailyMed Link:ivacaftor; lumacaftor at DailyMed
Recent Clinical Trials for ivacaftor; lumacaftor

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Assistance Publique - Hôpitaux de ParisN/A
University of MiamiEarly Phase 1
University of North CarolinaEarly Phase 1

See all ivacaftor; lumacaftor clinical trials

US Patents and Regulatory Information for ivacaftor; lumacaftor

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-001 Aug 7, 2018 RX Yes No   Start Trial   Start Trial   Start Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-002 Sep 28, 2016 RX Yes No   Start Trial   Start Trial   Start Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-001 Jul 2, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-002 Sep 28, 2016 RX Yes No   Start Trial   Start Trial Y   Start Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-002 Sep 28, 2016 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ivacaftor; lumacaftor

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2404919 122016000035 Germany   Start Trial PRODUCT NAME: 3-(6-((1-(2,2-DIFLUOR-1,3-BENZODIOXOL-5-YL)CYCLOPROPANCARBONYL)AMINO)-3-METHYLPYRIDIN-2-YL)BENZOESAEURE, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, ODER EIN ESTER-PRODRUG DAVON.; REGISTRATION NO/DATE: EU/1/15/1059 20151119
2404919 17/2016 Austria   Start Trial PRODUCT NAME: LUMACAFTOR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON ODER EIN ESTER PRODRUG DAVON; REGISTRATION NO/DATE: EU/1/15/1059 (MITTEILUNG) 20151124
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
2225230 2017009 Norway   Start Trial PRODUCT NAME: 3-6-(1-(2,2-DIFLUOR-1,3-; REG. NO/DATE: EU/1/15/1059 20151210
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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