Crizotinib - Generic Drug Details

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What are the generic drug sources for crizotinib and what is the scope of patent protection?

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:	155
Patent Applications:	339
What excipients (inactive ingredients) are in crizotinib?	crizotinib excipients list
DailyMed Link:	crizotinib at DailyMed

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

Generic Entry Dates for crizotinib^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: CAPSULE;ORAL
Generic Entry Dates for crizotinib^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
Hunan Province Tumor Hospital	Phase 1/Phase 2
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair	Phase 2/Phase 3
Zai Lab (Shanghai) Co., Ltd.	Phase 3

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

Anatomical Therapeutic Chemical (ATC) Classes for crizotinib

L01ED	Anaplastic lymphoma kinase (ALK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for crizotinib

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Glossary

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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	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Pf Prism Cv	XALKORI	crizotinib	CAPSULE, PELLETS;ORAL	217581-002	Sep 7, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Pf Prism Cv	XALKORI	crizotinib	CAPSULE, PELLETS;ORAL	217581-003	Sep 7, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Pf Prism Cv	XALKORI	crizotinib	CAPSULE, PELLETS;ORAL	217581-002	Sep 7, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-002	Aug 26, 2011		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pf Prism Cv	XALKORI	crizotinib	CAPSULE, PELLETS;ORAL	217581-002	Sep 7, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Pf Prism Cv	XALKORI	crizotinib	CAPSULE, PELLETS;ORAL	217581-001	Sep 7, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

EU/EMA Drug Approvals for crizotinib

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for crizotinib

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Country	Patent Number	Title	Estimated Expiration
Japan	2007153893	POLYMORPH OF C-Met/HGFR INHIBITOR	⤷ Sign Up
Guatemala	200500225	COMPUESTOS DE AMINOHETEROARILO ENANTIOMERICAMENTE PUROS COMO INHIBIDORES DE PROTEINA QUINASA	⤷ Sign Up
New Zealand	568289	Polymorphs of (R)-3-[1-(2,6-dichloro-3-fluoro-phenyl)-ethoxy]-5-(1- piperidin-4-yl-1H-pyrazol-4-yl)-pyridin-2-ylamine	⤷ Sign Up
Eurasian Patent Organization	200700352	ЭНАНТИОМЕРНО ЧИСТЫЕ АМИНОГЕТЕРОАРИЛЬНЫЕ СОЕДИНЕНИЯ В КАЧЕСТВЕ ИНГИБИТОРОВ ПРОТЕИНКИНАЗЫ	⤷ Sign Up
Norway	20071290		⤷ Sign Up
Hong Kong	1105414	ENANTIOMERICALLY PURE AMINOHETEROARYL COMPOUNDS AS PROTEIN KINASE INHIBITORS	⤷ Sign Up
China	101321527	Method of treating abnormal cell growth	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for crizotinib

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1786785	122013000027	Germany	⤷ Sign Up	PRODUCT NAME: CRIZOTINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, HYDRATS ODER SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/12/793/001-004 20121023
1786785	449	Finland	⤷ Sign Up
1786785	2013C/021	Belgium	⤷ Sign Up	DETAILS ASSIGNMENT: CHANGE OF OWNER(S), OTHER
1786785	SPC/GB13/018	United Kingdom	⤷ Sign Up	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	PA2013005	Lithuania	⤷ Sign Up	PRODUCT NAME: CRIZOTINIBUM; REGISTRATION NO/DATE: EU/1/12/793/001 - EU/1/12/793/004 20121023
1786785	C01786785/01	Switzerland	⤷ Sign Up	FORMER OWNER: PFIZER INC., US
1786785	13C0015	France	⤷ Sign Up	PRODUCT NAME: CRIZOTINIB ET SES SELS, HYDRATES ET SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/793/001 20121026
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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