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Last Updated: June 25, 2021

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ORKAMBI Drug Profile


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Which patents cover Orkambi, and when can generic versions of Orkambi launch?

Orkambi is a drug marketed by Vertex Pharms Inc and is included in two NDAs. There are nineteen patents protecting this drug.

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

DrugPatentWatch® Generic Entry Outlook for Orkambi

Orkambi was eligible for patent challenges on July 2, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 11, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for ORKAMBI
International Patents:433
US Patents:19
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 18
Patent Applications: 1
Drug Prices: Drug price information for ORKAMBI
What excipients (inactive ingredients) are in ORKAMBI?ORKAMBI excipients list
DailyMed Link:ORKAMBI at DailyMed
Drug patent expirations by year for ORKAMBI
Drug Prices for ORKAMBI

See drug prices for ORKAMBI

DrugPatentWatch® Estimated Generic Entry Opportunity Date for ORKAMBI
Generic Entry Dates for ORKAMBI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
GRANULE;ORAL
Generic Entry Dates for ORKAMBI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;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.

Recent Clinical Trials for ORKAMBI

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

SponsorPhase
Istituto Auxologico ItalianoPhase 2
Assistance Publique - Hôpitaux de ParisN/A
University of North CarolinaEarly Phase 1

See all ORKAMBI clinical trials

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   Get Started Free   Get Started Free Y   Get Started Free
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-002 Sep 28, 2016 RX Yes No   Get Started Free   Get Started Free   Get Started Free
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-002 Aug 7, 2018 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
>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 ORKAMBI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2404919 249 5006-2016 Slovakia   Get Started Free PRODUCT NAME: LUMAKAFTOR; REGISTRATION NO/DATE: EU/1/15/1059 20151124
1773816 122015000050 Germany   Get Started Free 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
2404919 PA2016015,C2404919 Lithuania   Get Started Free 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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