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Last Updated: May 26, 2022

XALKORI Drug Patent Profile


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

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

This drug has one hundred and fifty patent family members in forty-seven 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

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

See drug prices for XALKORI

DrugPatentWatch® Estimated Generic Entry Opportunity Date for XALKORI
Generic Entry Date for XALKORI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;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 six US patents and three FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of XALKORI is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method of treating abnormal cell growth
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

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

Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Polymorphs of a c-MET/HGFR inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting XALKORI

TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER WHOSE TUMORS ARE ROS-1 POSITIVE.
Exclusivity Expiration: See Plans and Pricing

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: See Plans and Pricing

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: 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
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
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 202570-001 Aug 26, 2011 RX Yes No 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 Y Y 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

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: See Plans and Pricing

Australia

Patent: 06323025
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0619420
Estimated Expiration: See Plans and Pricing

Canada

Patent: 32283
Estimated Expiration: See Plans and Pricing

China

Patent: 1326175
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 13843
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 63302
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 63302
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 26477
Estimated Expiration: See Plans and Pricing

Israel

Patent: 1971
Estimated Expiration: See Plans and Pricing

Japan

Patent: 63619
Estimated Expiration: See Plans and Pricing

Patent: 07153893
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 8289
Estimated Expiration: See Plans and Pricing

Poland

Patent: 63302
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 63302
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 87650
Estimated Expiration: See Plans and Pricing

Patent: 08120338
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 63302
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0804374
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1146852
Estimated Expiration: See Plans and Pricing

Patent: 080074950
Estimated Expiration: See Plans and Pricing

Spain

Patent: 02419
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 89902
Estimated Expiration: See Plans and Pricing

Patent: 0730522
Estimated Expiration: See Plans and Pricing

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 1963302 See Plans and Pricing
Eurasian Patent Organization 010727 АМИНОГЕТЕРОАРИЛЬНЫЕ СОЕДИНЕНИЯ В КАЧЕСТВЕ ИНГИБИТОРОВ ПРОТЕИНКИНАЗ (AMINOHETEROARYL COMPOUNDS AS PROTEIN KINASE INHIBITORS) See Plans and Pricing
Brazil PI0407827 compostos de aminoeteroarila como inibidores de proteìna cinase See Plans and Pricing
European Patent Office 1603570 COMPOSES D'AMINOHETEROARYLE UTILISES EN TANT QU'INHIBITEURS DE PROTEINE KINASE (AMINOHETEROARYL COMPOUNDS AS PROTEIN KINASE INHIBITORS) See Plans and Pricing
Serbia 51362 ENANTIOMERNO ČISTA AMINOHETEROARIL JEDINJENJA KAO INHIBITORI PROTEIN KINAZA (ENANTIOMERICALLY PURE AMINOHETEROARYL COMPUNDS AS PROTEIN KINASE INHIBITORS) See Plans and Pricing
China 101321527 Method of treating abnormal cell growth See Plans and Pricing
Netherlands 1029799 Enantiomeer zuivere aminoheteroarylverbindingen als proteïnekinaseremmers. See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for XALKORI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1786785 C300587 Netherlands See Plans and Pricing 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 C 2013 011 Romania See Plans and Pricing 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 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 C01786785/01 Switzerland See Plans and Pricing PRODUCT NAME: CRIZOTINIB; REGISTRATION NO/DATE: SWISSMEDIC 62131 05.03.2012
1786785 C20130007 00075 Estonia See Plans and Pricing PRODUCT NAME: KRISOTINIIB;REG NO/DATE: K(2012)7617 LOPLIK 23.10.2012
1786785 449 Finland See Plans and Pricing
1786785 167 5008-2013 Slovakia See Plans and Pricing PRODUCT NAME: KRIZOTINIB; 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

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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.