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XALKORI Drug Profile

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When do Xalkori patents expire, and what generic alternatives are available?

Xalkori is a drug marketed by Pf Prism Cv and is included in one NDA. There are five patents protecting this drug.

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

The generic ingredient in XALKORI is crizotinib. One supplier is listed for this compound. Additional details are available on the crizotinib profile page.

US ANDA Litigation and Generic Entry Outlook for Xalkori

Xalkori was eligible for patent challenges on August 26, 2015.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 6, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for XALKORI

International Patents:	148
US Patents:	5
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	84
Clinical Trials:	40
Patent Applications:	3,159
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for XALKORI
DailyMed Link:	XALKORI at DailyMed

See drug prices for XALKORI

Generic Entry Opportunity Date for XALKORI

NDA:

202570

Dosage:

CAPSULE;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 XALKORI

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Phase 2
Ulrik Lassen	Phase 2

See all XALKORI clinical trials

Pharmacology for XALKORI

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 XALKORI

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	202570-001	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	Y
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-002	Aug 26, 2011		RX	Yes	Yes

International Patents for XALKORI

Country	Patent Number	Estimated Expiration
Montenegro	P52808
World Intellectual Property Organization (WIPO)	2007066187
South Korea	101026676
Japan	2008510790

Supplementary Protection Certificates for XALKORI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1786785	C300587	Netherlands		PRODUCT NAME: CRIZOTINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, HYDRAAT OF SOLVAAT; REGISTRATION NO/DATE: EU/1/12/793/001-004 20121023
1786785	449	Finland
1786785	C01786785/01	Switzerland		PRODUCT NAME: CRIZOTINIB; REGISTRATION NO/DATE: SWISSMEDIC 62131 05.03.2012
1786785	SPC/GB13/018	United Kingdom		PRODUCT NAME: CRIZOTINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF.; REGISTERED: UK EU/1/12/793/001 20121026; UK EU/1/12/793/002 20121026; UK EU/1/12/793/003 20121026; UK EU/1/12/793/004 20121026