CRIZOTINIB - Generic Drug Details

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 two NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for CRIZOTINIB

International Patents:	152
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	99
Clinical Trials:	150
Patent Applications:	339
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in CRIZOTINIB?	CRIZOTINIB excipients list
DailyMed Link:	CRIZOTINIB at DailyMed

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

Dosage:

CAPSULE;ORAL

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 CRIZOTINIB

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

Sponsor	Phase
Xuanzhu Biopharmaceutical Co., Ltd.	Phase 2
Nuvalent Inc.	Phase 1/Phase 2
CStone Pharmaceuticals	Phase 2

See all CRIZOTINIB clinical trials

Pharmacology for CRIZOTINIB

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 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	202570-001	Aug 26, 2011		RX	Yes	No				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, PELLETS;ORAL	217581-003	Sep 7, 2023		RX	Yes	Yes				Y
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-001	Aug 26, 2011		RX	Yes	No			Y	Y

EU/EMA Drug Approvals for CRIZOTINIB

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 CRIZOTINIB

Country	Patent Number	Title	Estimated Expiration
Taiwan	200727899	Method of treating abnormal cell growth
Iceland	2910
Cyprus	1113843
Eurasian Patent Organization	200700352	ЭНАНТИОМЕРНО ЧИСТЫЕ АМИНОГЕТЕРОАРИЛЬНЫЕ СОЕДИНЕНИЯ В КАЧЕСТВЕ ИНГИБИТОРОВ ПРОТЕИНКИНАЗЫ
Uruguay	29081	COMPUESTOS DE AMINOHETEROARILO ENANTIOMÉRICAMENTE PUROS COMO INHIBIDORES DE PROTEÍNA QUINASA

Supplementary Protection Certificates for CRIZOTINIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1786785	92155	Luxembourg		PRODUCT NAME: CRIZOTINIB, EVENTUELLEMENT SOUS LA FORME D UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE
1786785	PA2013005,C1786785	Lithuania		PRODUCT NAME: CRIZOTINIBUM; REGISTRATION NO/DATE: EU/1/12/793/001 - EU/1/12/793/004, 2 00121023
1786785	449	Finland
1786785	C01786785/01	Switzerland		FORMER OWNER: PFIZER INC., US
1786785	CA 2013 00009	Denmark