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Last Updated: September 28, 2021

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Ivacaftor; lumacaftor - Generic Drug Details

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What are the generic 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 twenty patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ivacaftor; lumacaftor has four hundred and forty-two 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:442
US Patents:20
Tradenames:1
Applicants:1
NDAs:2
Drug Master File Entries: 3
Finished Product Suppliers / Packagers: 1
Clinical Trials: 35
DailyMed Link:ivacaftor; lumacaftor at DailyMed
Recent Clinical Trials for ivacaftor; lumacaftor

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

SponsorPhase
Istituto Auxologico ItalianoPhase 2
Assistance Publique - Hôpitaux de ParisN/A
University of MiamiEarly 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 211358-002 Aug 7, 2018 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-002 Aug 7, 2018 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-001 Jul 2, 2015 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-002 Sep 28, 2016 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 17/2016 Austria ⤷  Free Forever Trial PRODUCT NAME: LUMACAFTOR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON ODER EIN ESTER PRODRUG DAVON; REGISTRATION NO/DATE: EU/1/15/1059 (MITTEILUNG) 20151124
2404919 132016000049236 Italy ⤷  Free Forever Trial PRODUCT NAME: LUMACAFTOR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, O UN SUO ESTERE PROFARMACO(ORKAMBI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1059/001, 20151124
2395002 300812 Netherlands ⤷  Free Forever Trial PRODUCT NAME: 3-(6-((1-(2,2-DIFLUOR-1,3-BENZODIOXOL-5-YL)CYCLOPROPAANCARBONYL)AMINO)-3-METHYLPYRIDIN-2-YL)BENZOEZUUR, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/15/1059 20151124
3170818 301060 Netherlands ⤷  Free Forever Trial PRODUCT NAME: EEN COMBINATIE VAN (A) 3-(6-(1-(2,2-DIFLUORBENZO(D)(1,3)DIOXOL-5-YL)CYCLOPROPAANCARBOXAMIDO)-3-METHYLPYRIDIN-2-YL)BENZOEZUUR EN (B) N-(5-HYDROXY-2,4-DITERT-BUTYL-FENYL)-4-OXO-1H-CHINOLINE-3-CARBOXAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/15/1059 20151124
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Merck
AstraZeneca
Medtronic
Harvard Business School
Baxter

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