You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 24, 2024

~ Buy the XALKORI (crizotinib) Drug Profile, 2024 PDF Report in the Report Store ~

XALKORI Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Xalkori patents expire, and what generic alternatives are available?

Xalkori is a drug marketed by Pf Prism Cv and is included in two NDAs. There are five patents protecting this drug.

This drug has one hundred and fifty-one patent family members in forty-eight countries.

The generic ingredient in XALKORI is crizotinib. One supplier is listed for this compound. Additional details are available on the crizotinib profile page.

DrugPatentWatch® Generic Entry Outlook for Xalkori

Xalkori was eligible for patent challenges on August 26, 2015.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 6, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

< Available with Subscription >

  Try a Trial

Summary for XALKORI
Drug patent expirations by year for XALKORI
Drug Prices for XALKORI

See drug prices for XALKORI

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for XALKORI
Generic Entry Dates for XALKORI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL
Generic Entry Dates for XALKORI*:
Constraining patent/regulatory exclusivity:
NDA:
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 XALKORI

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

SponsorPhase
Ulrik LassenPhase 2
GlaxoSmithKlinePhase 2
Cancer Institute and Hospital, Chinese Academy of Medical SciencesPhase 2

See all XALKORI clinical trials

US Patents and Regulatory Information for XALKORI

XALKORI is protected by seven US patents and four FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of XALKORI is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting XALKORI

Aminoheteroaryl compounds as protein kinase inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Method of treating abnormal cell growth
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) THAT IS ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE

Method of treating abnormal cell growth
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF REVERSING OR INHIBITING THE PROGRESS OF UNRESECTABLE, RECURRENT, OR REFRACTORY INFLAMMATORY MYOFIBROBLASTIC TUMOR (IMT) THAT IS ALK-POSITIVE IN ADULT AND PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER

Method of treating abnormal cell growth
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER AND YOUNG ADULTS WITH RELAPSED OR REFRACTORY, SYSTEMIC ANAPLASTIC LARGE CELL LYMPHOMA (ALCL) THAT IS ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE

Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Polymorphs of a c-MET/HGFR inhibitor
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting XALKORI

TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER AND YOUNG ADULTS WITH RELAPSED OR REFRACTORY, SYSTEMIC ANAPLASTIC LARGE CELL LYMPHOMA (ALCL) THAT IS ALK-POSITIVE
Exclusivity Expiration: ⤷  Try a Trial

TREATMENT OF ADULT AND PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH UNRESECTABLE, RECURRENT OR REFRACTORY INFLAMMATORY MYOFIBROBLASTIC TUMOR (IMT) THAT IS ANAPLASTIC LYMPHOMA KINASE (ALK) POSITIVE
Exclusivity Expiration: ⤷  Try a Trial

TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER AND YOUNG ADULTS WITH RELAPSED OR REFRACTORY, SYSTEMIC ANAPLASTIC LARGE CELL LYMPHOMA (ALCL) THAT IS ALK-POSITIVE
Exclusivity Expiration: ⤷  Try a Trial

TREATMENT OF ADULT AND PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH UNRESECTABLE, RECURRENT, OR REFRACTORY INFLAMMATORY MYOFIBROBLASTIC TUMOR (IMT) THAT IS ALK-POSITIVE
Exclusivity Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Pf Prism Cv XALKORI crizotinib CAPSULE;ORAL 202570-002 Aug 26, 2011 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv XALKORI crizotinib CAPSULE;ORAL 202570-002 Aug 26, 2011 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
>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 XALKORI

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 XALKORI

When does loss-of-exclusivity occur for XALKORI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 7964
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 06323025
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0619420
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 32283
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1326175
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 13843
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 63302
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 63302
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 26477
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 1971
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 63619
Estimated Expiration: ⤷  Try a Trial

Patent: 07153893
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 8289
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 63302
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 63302
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 87650
Estimated Expiration: ⤷  Try a Trial

Patent: 08120338
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 63302
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0804374
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1146852
Estimated Expiration: ⤷  Try a Trial

Patent: 080074950
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 02419
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 89902
Estimated Expiration: ⤷  Try a Trial

Patent: 0730522
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering XALKORI around the world.

Country Patent Number Title Estimated Expiration
Portugal 2476667 ⤷  Try a Trial
Serbia 51362 ENANTIOMERNO ČISTA AMINOHETEROARIL JEDINJENJA KAO INHIBITORI PROTEIN KINAZA (ENANTIOMERICALLY PURE AMINOHETEROARYL COMPUNDS AS PROTEIN KINASE INHIBITORS) ⤷  Try a Trial
New Zealand 568654 Method of treating abnormal cell growth ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for XALKORI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1786785 122013000027 Germany ⤷  Try a Trial 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 13C0015 France ⤷  Try a Trial PRODUCT NAME: CRIZOTINIB ET SES SELS, HYDRATES ET SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/793/001 20121026
1786785 12/2013 Austria ⤷  Try a Trial PRODUCT NAME: CRIZOTINIB, BEVORZUGT IN FORM EINES PHARMAZEUTISCH AKZEPTABLEN SALZES, HYDRATS ODER SOLVATS; REGISTRATION NO/DATE: EU/1/12/793/001 - EU/1/12/793/004 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.