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Last Updated: March 28, 2020

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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 seventeen patents protecting this drug.

This drug has three hundred and thirty-six 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.

US ANDA Litigation and 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
Drug patent expirations by year for ORKAMBI
Drug Prices for ORKAMBI

See drug prices for ORKAMBI

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
Assistance Publique - Hôpitaux de ParisN/A
University of North CarolinaEarly Phase 1
University of MiamiEarly Phase 1

See all ORKAMBI clinical trials

Synonyms for ORKAMBI
1815566-23-4
Ivacaftor mixture with lumacaftor
Lumacaftor / Ivacaftor
Lumacaftor and 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   Start Trial   Start Trial Y   Start Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-002 Sep 28, 2016 RX Yes No   Start Trial   Start Trial Y   Start Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-002 Aug 7, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-002 Sep 28, 2016 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-001 Jul 2, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-002 Sep 28, 2016 RX Yes No   Start Trial   Start Trial Y   Start Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-002 Sep 28, 2016 RX Yes No   Start Trial   Start Trial Y   Start 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 ORKAMBI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2404919 C02404919/01 Switzerland   Start Trial PRODUCT NAME: 3-(6-((1-(2,2-DIFLUOR-1,3-BENZODIOXOL-5-YL)CYCLOPROPANCARBONYL)AMINO)-3-METHYLPYRIDIN-2-YL)BENZOESAEURE (LUMACAFTOR); REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65981 02.09.2016
1773816 CR 2015 00038 Denmark   Start Trial PRODUCT NAME: N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLIN-3-CARBOXAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/12/782/001-002 20120725
2404919 17/2016 Austria   Start Trial PRODUCT NAME: LUMACAFTOR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON ODER EIN ESTER PRODRUG DAVON; REGISTRATION NO/DATE: EU/1/15/1059 (MITTEILUNG) 20151124
1773816 PA2015028,C1773816 Lithuania   Start Trial PRODUCT NAME: IVAKAFTORAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002, 0120723
2404919 PA2016015,C2404919 Lithuania   Start Trial 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
1773816 15C0045 France   Start Trial PRODUCT NAME: IVACAFTOR, OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725
1773816 35/2015 Austria   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
McKinsey
Medtronic
AstraZeneca
Baxter
Moodys

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