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Last Updated: July 13, 2020

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COMETRIQ Drug Profile


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Which patents cover Cometriq, and when can generic versions of Cometriq launch?

Cometriq is a drug marketed by Exelixis and is included in one NDA. There are three patents protecting this drug.

This drug has one hundred and fifty-four patent family members in twenty-nine countries.

The generic ingredient in COMETRIQ is cabozantinib s-malate. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cabozantinib s-malate profile page.

US ANDA Litigation and Generic Entry Outlook for Cometriq

Cometriq was eligible for patent challenges on November 29, 2016.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for COMETRIQ
Drug Prices for COMETRIQ

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Recent Clinical Trials for COMETRIQ

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SponsorPhase
ExelixisPhase 1/Phase 2
National Cancer Institute (NCI)Phase 1/Phase 2
University of WashingtonPhase 1/Phase 2

See all COMETRIQ clinical trials

Pharmacology for COMETRIQ
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors

US Patents and Regulatory Information for COMETRIQ

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Exelixis COMETRIQ cabozantinib s-malate CAPSULE;ORAL 203756-001 Nov 29, 2012 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Exelixis COMETRIQ cabozantinib s-malate CAPSULE;ORAL 203756-002 Nov 29, 2012 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Exelixis COMETRIQ cabozantinib s-malate CAPSULE;ORAL 203756-001 Nov 29, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Exelixis COMETRIQ cabozantinib s-malate CAPSULE;ORAL 203756-001 Nov 29, 2012 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Exelixis COMETRIQ cabozantinib s-malate CAPSULE;ORAL 203756-002 Nov 29, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Exelixis COMETRIQ cabozantinib s-malate CAPSULE;ORAL 203756-002 Nov 29, 2012 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for COMETRIQ

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2213661 CR 2014 00039 Denmark   Start Trial PRODUCT NAME: CABOZANTINIB, INKLUSIVE FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER CABOZANTINIB (S)-MALAT; REG. NO/DATE: EU/1/13/890/001-003 20140326
2213661 PA2014033 Lithuania   Start Trial PRODUCT NAME: CABOZANTINIBUM; REGISTRATION NO/DATE: EU/1/13/890/001 - EU/1/13/890/003 20140321
2213661 CA 2014 00039 Denmark   Start Trial PRODUCT NAME: CABOZANTINIB, INKLUSIVE FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER CABOZANTINIB (S)-MALAT; REG. NO/DATE: EU/1/13/890/001-003 20140321
2213661 122014000091 Germany   Start Trial PRODUCT NAME: CABOZANTINIB UND JEDES THERAPEUTISCHE AEQUIVALENT HIERVON WIE DURCH DAS GRUNDPATENT GESCHUETZT, EINSCHLIESSLICH PHARMAZEUTISCH ANNEHMBARER SALZE; REGISTRATION NO/DATE: EU/1/13/890/001-003 20140321
2213661 92508 Luxembourg   Start Trial PRODUCT NAME: CABOZANTINIB ET TOUTES LES FORMES THERAPEUTIQUEMENT EQUIVALENTES QUI EN DERIVENT TELLES QUE PROTEGEES PAR LE BREVET DE BASE, Y COMPRIS LES SELS PHARMACEUTIQUEMENT ACCEPTABLES. FIRST REGISTRATION: 20140326
2213661 220 50007-2014 Slovakia   Start Trial PRODUCT NAME: CABOZANTINIB; REGISTRATION NO/DATE: EU/1/13/890/001 - EU/1/13/890/003 20140326
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
McKinsey
Dow
McKesson
Baxter
Boehringer Ingelheim

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