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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Express Scripts
Boehringer Ingelheim
Cipla
Cantor Fitzgerald
Deloitte
US Department of Justice
Teva
Federal Trade Commission

Generated: December 14, 2018

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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 ivacaftor; lumacaftor 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 two hundred and eighty-nine patent family members in thirty-four countries.

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

Summary for ivacaftor; lumacaftor
International Patents:289
US Patents:17
Tradenames:1
Applicants:1
NDAs:2
Drug Master File Entries: 3
Suppliers / Packagers: 1
Clinical Trials: 30
DailyMed Link:ivacaftor; lumacaftor at DailyMed

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

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Supplementary Protection Certificates for ivacaftor; lumacaftor

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0748 Netherlands ➤ Sign Up PRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-FENYL)-4-OXO-1H-CHINOLINE-3-CARBOXAMIDE (INN: IVACAFTOR) OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725
15/036 Ireland ➤ Sign Up PRODUCT NAME: N-(5-HYDROXYL-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3- CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120723
2015000050 Germany ➤ Sign Up PRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-PHENYL)-4-OXO-1H-CHINOLIN-3-CARBONSAEUREAMID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120723
0812 Netherlands ➤ Sign Up 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
2015028,C1773816 Lithuania ➤ Sign Up PRODUCT NAME: IVAKAFTORAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002, 0120723
2015028 Lithuania ➤ Sign Up PRODUCT NAME: IVACAFTORUM; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002 20120723
0150028 00162 Estonia ➤ Sign Up PRODUCT NAME: IVAKAFTOOR;REG NO/DATE: EU/1/12/782/001-002 25.07.2012
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Express Scripts
Boehringer Ingelheim
Cipla
Cantor Fitzgerald
Deloitte
US Department of Justice
Teva
Federal Trade Commission

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