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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

Summary for ORKAMBI

International Patents:	336
US Patents:	17
Applicants:	1
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	1
Clinical Trials:	16
Patent Applications:	1
Drug Prices:	Drug price information for ORKAMBI
DailyMed Link:	ORKAMBI at DailyMed

See drug prices for ORKAMBI

Generic Entry Opportunity Date for ORKAMBI

NDA:

211358

Dosage:

GRANULE;ORAL

NDA:

206038

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

Sponsor	Phase
Assistance Publique - Hôpitaux de Paris	N/A
University of North Carolina	Early Phase 1
University of Miami	Early Phase 1

See all ORKAMBI clinical trials

Pharmacology for ORKAMBI

Drug Class	Cystic Fibrosis Transmembrane Conductance Regulator Potentiator
Mechanism of Action	Cytochrome P450 3A Inducers Cytochrome P450 2B6 Inducers Cytochrome P450 2C8 Inducers Cytochrome P450 2C9 Inducers Cytochrome P450 2C19 Inducers Cytochrome P450 2C8 Inhibitors Cytochrome P450 2C9 Inhibitors P-Glycoprotein Inducers P-Glycoprotein Inhibitors Chloride Channel Activation Potentiators Cytochrome P450 3A4 Inhibitors Cytochrome P450 3A Inhibitors

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			Y
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	TABLET;ORAL	206038-002	Sep 28, 2016		RX	Yes	No			Y
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	GRANULE;ORAL	211358-002	Aug 7, 2018		RX	Yes	Yes			Y
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	TABLET;ORAL	206038-002	Sep 28, 2016		RX	Yes	No			Y	Y
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	TABLET;ORAL	206038-001	Jul 2, 2015		RX	Yes	Yes
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	TABLET;ORAL	206038-002	Sep 28, 2016		RX	Yes	No			Y
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	TABLET;ORAL	206038-002	Sep 28, 2016		RX	Yes	No			Y

International Patents for ORKAMBI

Country	Patent Number	Estimated Expiration
Japan	2013513617
Lithuania	C2404919
Japan	2016128436
China	103641765
Japan	2017149778
South Korea	20140009566
Poland	2774925

Supplementary Protection Certificates for ORKAMBI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2404919	C02404919/01	Switzerland		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		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		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		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		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		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		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