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Last Updated: November 29, 2022

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 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 fifty patent family members in forty-seven countries.

One supplier is listed for this compound.

Summary for crizotinib
International Patents:150
US Patents:5
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 95
Clinical Trials: 148
Patent Applications: 326
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

SponsorPhase
Xuanzhu Biopharmaceutical Co., Ltd.Phase 2
Nuvalent Inc.Phase 1/Phase 2
CStone PharmaceuticalsPhase 2

See all crizotinib clinical trials

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pf Prism Cv XALKORI crizotinib CAPSULE;ORAL 202570-002 Aug 26, 2011 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pf Prism Cv XALKORI crizotinib CAPSULE;ORAL 202570-001 Aug 26, 2011 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pf Prism Cv XALKORI crizotinib CAPSULE;ORAL 202570-002 Aug 26, 2011 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

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 is indicated for the first-line treatment of adults with anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC).Xalkori is indicated for the treatment of adults with previously treated anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC).
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

Country Patent Number Title Estimated Expiration
Costa Rica 8860 COMPUESTOS DE AMINOHETEROARILO ENANTIOMETRICAMENTE PUROS COMO INHIBIDORES DE PROTEINA QUINASA See Plans and Pricing
Ukraine 87153 ЭНАНТИОМЕРНО ЧИСТЫЕ АМИНОГЕТЕРОАРИЛЬНЫЕ СОЕДИНЕНИЯ КАК ИНГИБИТОРЫ ПРОТЕИНКИНАЗЫ;ЕНАНТІОМЕРНО ЧИСТІ АМІНОГЕТЕРОАРИЛЬНІ СПОЛУКИ ЯК ІНГІБІТОРИ ПРОТЕЇНКІНАЗИ (ENANTIOMERICALLY PURE AMINOHETEROARYL COMPOUNDS AS PROTEIN KINASE INHIBITORS) See Plans and Pricing
African Regional IP Organization (ARIPO) 2373 Enantiomerically pure aminoheteroaryl compounds asprotein kinase inhibitors. See Plans and Pricing
South Korea 101026676 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for crizotinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1786785 SPC/GB13/018 United Kingdom See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: CRIZOTINIBUM; REGISTRATION NO/DATE: EU/1/12/793/001 - EU/1/12/793/004 20121023
1786785 449 Finland See Plans and Pricing
1786785 PA2013005,C1786785 Lithuania See Plans and Pricing PRODUCT NAME: CRIZOTINIBUM; REGISTRATION NO/DATE: EU/1/12/793/001 - EU/1/12/793/004, 0121023
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Merck
Mallinckrodt
McKinsey
AstraZeneca
Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.