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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 patent protection?

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

Ivacaftor; ivacaftor, tezacaftor has three hundred and forty-three patent family members in thirty-seven 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:	343
US Patents:	20
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	3
Suppliers / Packagers:	1
Clinical Trials:	29
DailyMed Link:	ivacaftor; ivacaftor, tezacaftor at DailyMed

Recent Clinical Trials for ivacaftor; ivacaftor, tezacaftor

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

Sponsor	Phase
Children's Hospital Medical Center, Cincinnati	N/A
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	210491-002	Jun 21, 2019		RX	Yes	No			Y	Y
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	210491-002	Jun 21, 2019		RX	Yes	No			Y	Y
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET, TABLET;ORAL	210491-002	Jun 21, 2019		RX	Yes	No			Y
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET, TABLET;ORAL	210491-002	Jun 21, 2019		RX	Yes	No			Y
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET, TABLET;ORAL	210491-002	Jun 21, 2019		RX	Yes	No
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
Hungary	E039062
Lithuania	1993360
European Patent Office	2563778
Denmark	2464337
Israel	180224
European Patent Office	2502911
Japan	2015172087

Supplementary Protection Certificates for ivacaftor; ivacaftor, tezacaftor

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1773816	92761	Luxembourg		PRODUCT NAME: N-(5-HYDROXY-2,4-DIERT-BUTYL-PHENYL)-4OXO-1H-QUINOLINE-3-CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; FIRST REGISTRATION: 20120725
1773816	1590036-8	Sweden		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
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	PA2015028	Lithuania		PRODUCT NAME: IVACAFTORUM; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002 20120723
1773816	CA 2015 00038	Denmark		PRODUCT NAME: IVACAFTOR, N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLIN-3-CARBOXAMID ELLER ET FARMACEUTISK ACCEPTABLET SALT DERAF; REG. NO/DATE: EU/1/12/782/001-002 20120723
1773816	C20150028 00162	Estonia		PRODUCT NAME: IVAKAFTOOR;REG NO/DATE: EU/1/12/782/001-002 25.07.2012
1773816	132016000022519	Italy		PRODUCT NAME: IVACAFTOR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(KALYDECO); AUTHORISATION NUMBER(S) AND DATE(S): EU/12/782/001-002, 20120725