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CRIZOTINIB - Generic Drug Details

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What are the generic sources for crizotinib and what is the scope of freedom to operate?

Crizotinib is the generic ingredient in one branded drug marketed by Pf Prism Cv and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Crizotinib has one hundred and forty-eight patent family members in forty-seven countries.

One supplier is listed for this compound.

Summary for CRIZOTINIB

International Patents:	148
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	84
Clinical Trials:	135
Patent Applications:	3,188
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in CRIZOTINIB?	CRIZOTINIB excipients list
DailyMed Link:	CRIZOTINIB at DailyMed

Recent Clinical Trials for CRIZOTINIB

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

Sponsor	Phase
Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Phase 2
AnHeart Therapeutics Inc.	Phase 2
Ulrik Lassen	Phase 2

See all CRIZOTINIB clinical trials

Pharmacology for CRIZOTINIB

Drug Class	Kinase Inhibitor
Mechanism of Action	Cytochrome P450 3A Inhibitors Receptor Tyrosine Kinase Inhibitors Cytochrome P450 2B6 Inhibitors P-Glycoprotein Inhibitors Organic Cation Transporter 1 Inhibitors Organic Cation Transporter 2 Inhibitors

US Patents and Regulatory Information for CRIZOTINIB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-002	Aug 26, 2011		RX	Yes	Yes
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-001	Aug 26, 2011		RX	Yes	No			Y	Y
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-001	Aug 26, 2011		RX	Yes	No
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-002	Aug 26, 2011		RX	Yes	Yes
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-001	Aug 26, 2011		RX	Yes	No				Y
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-002	Aug 26, 2011		RX	Yes	Yes				Y
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-002	Aug 26, 2011		RX	Yes	Yes				Y

International Patents for CRIZOTINIB

Country	Patent Number	Estimated Expiration
Australia	2006323027
South Africa	200804374
Israel	191471
Spain	2402419
Poland	378759
Norway	332188
South Korea	101106905

Supplementary Protection Certificates for CRIZOTINIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1786785	C 2013 011	Romania		PRODUCT NAME: CRIZOTINIB, OPTIONAL IN FORMA DE SARE ACCEPTABILAFARMACEUTIC, HIDRAT SAU SOLVAT AL ACESTUIA; NATIONAL AUTHORISATION NUMBER: RO EU/1/12/793/001, RO EU/1/12/793/002, RO EU/1/12/793/003, RO EU/1/12/793/004; DATE OF NATIONAL AUTHORISATION: 20121023; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/12/793/001, EMEA EU/1/12/793/002, EMEA EU/1/12/793/003, EMEA EU/1/12/793/004; DATE OF FIRST AUTHORISATION IN EEA: 20121023
1786785	449	Finland
1786785	92155	Luxembourg		PRODUCT NAME: CRIZOTINIB, EVENTUELLEMENT SOUS LA FORME D UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE
1786785	PA2013005	Lithuania		PRODUCT NAME: CRIZOTINIBUM; REGISTRATION NO/DATE: EU/1/12/793/001 - EU/1/12/793/004 20121023
1786785	13C0015	France		PRODUCT NAME: CRIZOTINIB ET SES SELS, HYDRATES ET SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/793/001 20121023
1786785	C20130007 00075	Estonia		PRODUCT NAME: KRISOTINIIB;REG NO/DATE: K(2012)7617 LOPLIK 23.10.2012
1786785	PA2013005,C1786785	Lithuania		PRODUCT NAME: CRIZOTINIBUM; REGISTRATION NO/DATE: EU/1/12/793/001 - EU/1/12/793/004, 0121023