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Generated: May 22, 2019

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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 two NDAs. There are seventeen patents protecting this drug.

This drug has three hundred and twenty-three patent family members in thirty-four 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.

Summary for ORKAMBI
Drug patent expirations by year for ORKAMBI
Generic Entry Opportunity Date for ORKAMBI
Generic Entry Dates for ORKAMBI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL
Generic Entry Dates for ORKAMBI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
GRANULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Synonyms for ORKAMBI
1815566-23-4
Ivacaftor mixture with lumacaftor
Lumacaftor / Ivacaftor
Lumacaftor and ivacaftor tablet
Lumacaftor, ivacaftor drug combination
S900006790
SCHEMBL19410545
VX 700-VX 809 combination
VX 809-VX 770 combination

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 ➤ 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 ➤ Sign Up
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-002 Aug 7, 2018 RX Yes Yes ➤ 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 ORKAMBI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1773816 300748 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
2404919 93073 Luxembourg ➤ Sign Up PRODUCT NAME: ACIDE BENZOIQUE 3-{6-{-1-(2,2-DIFLUORO-1,3-BENZODIOXOL-5-YL)CYCLOPROPANECARBONYL AMINO}-3-METHYLPYRIDIN-2-YL}, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, OU UN PRO-MEDICAMENT DE TYPE ESTER DE CELUI-CI; FIRST REGISTRATION DATE: 20151124
1773816 1590036-8 Sweden ➤ Sign Up 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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