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XALKORI Drug Patent Profile

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

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

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

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

DrugPatentWatch^® 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:	152
US Patents:	5
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	99
Clinical Trials:	51
Patent Applications:	2,843
Drug Prices:	Drug price information for XALKORI
What excipients (inactive ingredients) are in XALKORI?	XALKORI excipients list
DailyMed Link:	XALKORI at DailyMed

See drug prices for XALKORI

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for XALKORI

NDA:

202570

Dosage:

CAPSULE;ORAL

NDA:

217581

Dosage:

CAPSULE, PELLETS;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
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair	Phase 2/Phase 3
Bristol-Myers Squibb	Phase 3
Zai Lab (Shanghai) Co., Ltd.	Phase 3

See all XALKORI clinical trials

Pharmacology for XALKORI

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

US Patents and Regulatory Information for XALKORI

XALKORI is protected by seven US patents and four FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting XALKORI

FDA Regulatory Exclusivity protecting 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			Y	Y
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-002	Aug 26, 2011		RX	Yes	Yes
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-002	Aug 26, 2011		RX	Yes	Yes			Y	Y
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-001	Aug 26, 2011		RX	Yes	No
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-001	Aug 26, 2011		RX	Yes	No				Y

EU/EMA Drug Approvals for XALKORI

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Europe MA EEIG	Xalkori	crizotinib	EMEA/H/C/002489 XALKORI as monotherapy is indicated for:The first‑line treatment of adults with anaplastic lymphoma kinase (ALK)‑positive advanced non‑small cell lung cancer (NSCLC)The treatment of adults with previously treated anaplastic lymphoma kinase (ALK)‑positive advanced non‑small cell lung cancer (NSCLC)The treatment of adults with ROS1‑positive advanced non‑small cell lung cancer (NSCLC)The treatment of paediatric patients (age ≥6 to	Authorised	no	no	no	2012-10-23

International Patents for XALKORI

When does loss-of-exclusivity occur for XALKORI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Cyprus

Denmark

European Patent Office

Hong Kong

Israel

Japan

New Zealand

Poland

Portugal

Russian Federation

Slovenia

South Africa

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering XALKORI around the world.

Country	Patent Number	Title	Estimated Expiration
New Zealand	568654	Method of treating abnormal cell growth
Russian Federation	2384331	СПОСОБ ЛЕЧЕНИЯ АНОМАЛЬНОГО РОСТА КЛЕТОК (METHOD OF TREATING ABNORMAL CELL EXPANSION)
Spain	2353821
China	101023064	Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors
Uruguay	29081	COMPUESTOS DE AMINOHETEROARILO ENANTIOMÉRICAMENTE PUROS COMO INHIBIDORES DE PROTEÍNA QUINASA

Supplementary Protection Certificates for XALKORI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1786785	C01786785/01	Switzerland		FORMER OWNER: PFIZER INC., US
1786785	C 2013 011	Romania		PRODUCT NAME: CRIZOTINIB, OPTIONAL IN FORMA DE SARE ACCEPTABILAFARMACEUTIC, HIDRAT SAU SOLVAT AL ACE 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 STUIA; NATIONAL AUTHORISATION NUMBER: RO EU/1/12/793/001, RO EU/1/12/793/002, RO EU/1/12/793/003, RO
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	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
1786785	122013000027	Germany		PRODUCT NAME: CRIZOTINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, HYDRATS ODER SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/12/793/001-004 20121023