You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 22, 2024

Crizotinib - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic 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;ORAL 202570-002 Aug 26, 2011 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pf Prism Cv XALKORI crizotinib CAPSULE;ORAL 202570-001 Aug 26, 2011 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  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;ORAL 202570-001 Aug 26, 2011 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pf Prism Cv XALKORI crizotinib CAPSULE, PELLETS;ORAL 217581-003 Sep 7, 2023 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
New Zealand 568654 Method of treating abnormal cell growth ⤷  Sign Up
Russian Federation 2384331 СПОСОБ ЛЕЧЕНИЯ АНОМАЛЬНОГО РОСТА КЛЕТОК (METHOD OF TREATING ABNORMAL CELL EXPANSION) ⤷  Sign Up
Spain 2353821 ⤷  Sign Up
China 101023064 Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors ⤷  Sign Up
Uruguay 29081 COMPUESTOS DE AMINOHETEROARILO ENANTIOMÉRICAMENTE PUROS COMO INHIBIDORES DE PROTEÍNA 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 C01786785/01 Switzerland ⤷  Sign Up FORMER OWNER: PFIZER INC., US
1786785 C 2013 011 Romania ⤷  Sign Up 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 ⤷  Sign Up 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 ⤷  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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.