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Last Updated: December 11, 2024

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*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL
Generic Entry Dates for crizotinib*:
Constraining patent/regulatory exclusivity:
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

SponsorPhase
Hunan Province Tumor HospitalPhase 1/Phase 2
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB ChairPhase 2/Phase 3
Bristol-Myers SquibbPhase 3

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, PELLETS;ORAL 217581-001 Sep 7, 2023 RX Yes No ⤷  Sign Up ⤷  Sign Up Y 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;ORAL 202570-002 Aug 26, 2011 RX Yes Yes ⤷  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

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

Country Patent Number Title Estimated Expiration
Netherlands 1029799 Enantiomeer zuivere aminoheteroarylverbindingen als proteïnekinaseremmers. ⤷  Sign Up
Portugal 2476667 ⤷  Sign Up
Argentina 050788 COMPUESTOS DE AMINOHETEROARILO ENANTIOMERICAMENTE PUROS COMO INHIBIDORES DE PROTEINA QUINASA ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for crizotinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1786785 2013/009 Ireland ⤷  Sign Up PRODUCT NAME: PRODUCT (I.E. ACTIVE INGREDIENT OR COMBINATION OF ACTIVE INGREDIENTS) FOR WHICH A CERTIFICATE IS REQUESTED: CRIZOTINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/12/793/001 EU/1/12/793/004 20121023
1786785 CA 2013 00009 Denmark ⤷  Sign Up
1786785 PA2013005,C1786785 Lithuania ⤷  Sign Up PRODUCT NAME: CRIZOTINIBUM; REGISTRATION NO/DATE: EU/1/12/793/001 - EU/1/12/793/004, 2 00121023
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.