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Serving leading biopharmaceutical companies globally:

Accenture
Teva
Express Scripts
Harvard Business School
QuintilesIMS
Merck
Medtronic
Deloitte
UBS
Boehringer Ingelheim

Generated: January 20, 2018

DrugPatentWatch Database Preview

ORKAMBI Drug Profile

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When do Orkambi patents expire, and what generic alternatives are available?

Orkambi is a drug marketed by Vertex Pharms Inc and is included in one NDA. There are fifteen patents protecting this drug.

This drug has two hundred and thirty-two patent family members in thirty-two countries.

The generic ingredient in ORKAMBI is ivacaftor; lumacaftor. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ivacaftor; lumacaftor profile page.

US Patents and Regulatory Information for ORKAMBI

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 TABLET;ORAL 206038-001 Jul 2, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-001 Jul 2, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-001 Jul 2, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-001 Jul 2, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-002 Sep 28, 2016 RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-002 Sep 28, 2016 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-001 Jul 2, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-001 Jul 2, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-002 Sep 28, 2016 RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-001 Jul 2, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
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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Non-Orange Book US Patents for ORKAMBI

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,629,162 Modulators of ATP-binding cassette transporters ➤ Subscribe
7,741,321 Modulators of ATP-binding cassette transporters ➤ Subscribe
2,014,187,770 ➤ Subscribe
8,829,204 Modulators of ATP-binding cassette transporters ➤ Subscribe
8,318,733 Modulators of ATP-binding cassette transporters ➤ Subscribe
8,012,999 Modulators of CFTR ➤ Subscribe
7,754,739 Modulators of CFTR ➤ Subscribe
7,956,052 Modulators of ATP-binding cassette transporters ➤ Subscribe
9,840,499 Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-- methylpyridin-2-yl) benzoic acid ➤ Subscribe
8,324,207 Modulators of ATP-binding cassette transporters ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for ORKAMBI

Supplementary Protection Certificates for ORKAMBI

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2016 00019 Denmark ➤ Subscribe PRODUCT NAME: 3-(6-((1-(2,2-DIFLUOR-1,3-BENZODIOXOL-5-YL)CYCLOPROPANCATBONYL)AMINO)-3-METHYLPYRIDIN-2-YL)BENZOSYRE, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ELLER ET ESTERPRODRUG DERAF; REG. NO/DATE: EU/1/15/1059 20151124
/2015 Austria ➤ Subscribe PRODUCT NAME: N-(5-HYDROXY-2,4DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLIN-3-CARBOXAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/782/001, EU/1/12/782/002 (MITTEILUNG) 20120725
2016015 Lithuania ➤ Subscribe PRODUCT NAME: LUMAKAFTORAS/IVAKAFTORAS; REGISTRATION NO/DATE: EU/1/15/1059 20151119
2015028 Lithuania ➤ Subscribe PRODUCT NAME: IVACAFTORUM; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002 20120723
0748 Netherlands ➤ Subscribe 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
C0020 France ➤ Subscribe PRODUCT NAME: LUMACAFTOR, SES SELS PHARMACEUTIQUEMENT ACCEPTABLES OU SES PROMEDICAMENTS ESTERS; REGISTRATION NO/DATE: EU/1/15/1059 20151124
761 Luxembourg ➤ Subscribe PRODUCT NAME: N-(5-HYDROXY-2,4-DIERT-BUTYL-PHENYL)-4OXO-1H-QUINOLINE-3-CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; FIRST REGISTRATION: 20120725
0160015 00195 Estonia ➤ Subscribe PRODUCT NAME: LUMAKAFTOOR / IVAKAFTOOR;REG NO/DATE: EU/1/15/1059 24.11.2015
2016015,C2404919 Lithuania ➤ Subscribe PRODUCT NAME: 3-(6-((1-(2,2-DIFLUOR-1,3-BENZODIOKSOL-5-IL)CIKLOPROPANKARBONIL)AMINO)-3-METILPIRIDIN-2-IL)BENZOINE RUGSTIS ARBA JOS FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA ESTERIS; REGISTRATION NO/DATE: EU/1/15/1059 20151119
2015 00038 Denmark ➤ Subscribe 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Cipla
McKinsey
US Department of Justice
Chinese Patent Office
Baxter
Fuji
Chubb
Citi
Colorcon

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