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Ivacaftor; ivacaftor, tezacaftor - Generic Drug Details

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What are the generic sources for ivacaftor; ivacaftor, tezacaftor and what is the scope of freedom to operate?

Ivacaftor; ivacaftor, tezacaftor is the generic ingredient in one branded drug marketed by Vertex Pharms Inc and is included in one NDA. There are nineteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ivacaftor; ivacaftor, tezacaftor has two hundred and forty-eight patent family members in thirty-four countries.

There are three drug master file entries for ivacaftor; ivacaftor, tezacaftor. One supplier is listed for this compound.

Summary for ivacaftor; ivacaftor, tezacaftor

International Patents:	248
US Patents:	19
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	3
Suppliers / Packagers:	1
Clinical Trials:	22
DailyMed Link:	ivacaftor; ivacaftor, tezacaftor at DailyMed

Recent Clinical Trials for ivacaftor; ivacaftor, tezacaftor

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

Sponsor	Phase
Cystic Fibrosis Foundation	Phase 2
University of Nottingham	Phase 2
Cystic Fibrosis Trust	Phase 2

See all ivacaftor; ivacaftor, tezacaftor clinical trials

US Patents and Regulatory Information for ivacaftor; ivacaftor, tezacaftor

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	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET, TABLET;ORAL	210491-001	Feb 12, 2018		RX	Yes	Yes
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET, TABLET;ORAL	210491-001	Feb 12, 2018		RX	Yes	Yes
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET, TABLET;ORAL	210491-001	Feb 12, 2018		RX	Yes	Yes
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET, TABLET;ORAL	210491-001	Feb 12, 2018		RX	Yes	Yes			Y	Y
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET, TABLET;ORAL	210491-001	Feb 12, 2018		RX	Yes	Yes			Y

International Patents for ivacaftor; ivacaftor, tezacaftor

Country	Patent Number	Estimated Expiration
European Patent Office	3181561
Canada	2783314
Netherlands	300748
South Africa	200700601
Australia	2010249302

Supplementary Protection Certificates for ivacaftor; ivacaftor, tezacaftor

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1773816	122015000050	Germany		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
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
1773816	2015/036	Ireland		PRODUCT NAME: N-(5-HYDROXYL-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3- CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120723
1773816	300748	Netherlands		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
1773816	C300748	Netherlands		PRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725