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Last Updated: July 18, 2024

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COMETRIQ Drug Patent Profile


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Which patents cover Cometriq, and what generic alternatives are available?

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

This drug has one hundred and eighty-four patent family members in thirty-one 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.

DrugPatentWatch® Generic Entry Outlook for Cometriq

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

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 10, 2032. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases 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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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for COMETRIQ
Generic Entry Date for COMETRIQ*:
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 COMETRIQ

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

SponsorPhase
National Cancer Institute (NCI)Phase 2/Phase 3
Children's Oncology GroupPhase 2/Phase 3
Oregon Health and Science UniversityPhase 2

See all COMETRIQ clinical trials

Pharmacology for COMETRIQ
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors

US Patents and Regulatory Information for COMETRIQ

COMETRIQ is protected by seven US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of COMETRIQ is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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 COMETRIQ

Malate salt of N-(4-{[6,7-bis(methyloxy) quinolin-4-yl]oxy}phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxami- de, and crystalline forms therof for the treatment of cancer
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Malate salt of N-(4-{[6,7-bis(methyloxy) quinolin-4-yl]oxy}phenyl)- N'-(4-fluorophenyl)cyclopropane-1,1 -dicarboxamide, and crystalline forms thereof for the treatment of cancer
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Malate salt of N-(4-{[6,7-bis(methyloxy) quinolin-4-yl]oxy}phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxami- de, and crystalline forms thereof for the treatment of cancer
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING MEDULLARY THYROID CANCER

Processes for preparing quinoline compounds and pharmaceutical compositions containing such compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

c-Met modulators and methods of use
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

(L)-malate salt of N-(4-{[6,7-bis(methyloxy) quinolin-4-yl]oxy}phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxami- de
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING MEDULLARY THYROID CANCER

Processes for preparing quinoline compounds and pharmaceutical compositions containing such compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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 No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Exelixis COMETRIQ cabozantinib s-malate CAPSULE;ORAL 203756-001 Nov 29, 2012 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Exelixis COMETRIQ cabozantinib s-malate CAPSULE;ORAL 203756-001 Nov 29, 2012 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Exelixis COMETRIQ cabozantinib s-malate CAPSULE;ORAL 203756-002 Nov 29, 2012 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Exelixis COMETRIQ cabozantinib s-malate CAPSULE;ORAL 203756-002 Nov 29, 2012 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Exelixis COMETRIQ cabozantinib s-malate CAPSULE;ORAL 203756-002 Nov 29, 2012 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Exelixis COMETRIQ cabozantinib s-malate CAPSULE;ORAL 203756-001 Nov 29, 2012 RX Yes No ⤷  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

International Patents for COMETRIQ

When does loss-of-exclusivity occur for COMETRIQ?

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

Argentina

Patent: 5155
Patent: PROCESOS PARA PREPARAR COMPUESTOS DE QUINOLINA Y COMPOSICIONES FARMACEUTICAS QUE CONTIENEN DICHOS COMPUESTOS
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 12214322
Patent: Processes for preparing quinoline compounds and pharmaceutical compositions containing such compounds
Estimated Expiration: ⤷  Sign Up

Patent: 17204877
Patent: PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS
Estimated Expiration: ⤷  Sign Up

Patent: 19203745
Patent: PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS
Estimated Expiration: ⤷  Sign Up

Patent: 20273307
Patent: PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS
Estimated Expiration: ⤷  Sign Up

Patent: 22246429
Patent: PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2013020362
Patent: processos para a preparação de compostos de quinolina, compostos e combinações farmacêuticas que os contem
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 26751
Patent: PROCEDES DE SYNTHESE DE QUINOLEINES ET COMPOSITIONS PHARMACEUTIQUES LES INCLUANT (PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

China

Patent: 3459373
Patent: Processes for preparing quinoline compounds and pharmaceutical compositions containing such compounds
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 73262
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 3513
Patent: СПОСОБЫ ПОЛУЧЕНИЯ ХИНОЛИНОВЫХ СОЕДИНЕНИЙ И ФАРМАЦЕВТИЧЕСКИХ КОМПОЗИЦИЙ, СОДЕРЖАЩИХ ТАКИЕ СОЕДИНЕНИЯ (PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Patent: 1391145
Patent: СПОСОБЫ ПОЛУЧЕНИЯ ХИНОЛИНОВЫХ СОЕДИНЕНИЙ И ФАРМАЦЕВТИЧЕСКИХ КОМПОЗИЦИЙ, СОДЕРЖАЩИХ ТАКИЕ СОЕДИНЕНИЯ
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 73262
Patent: PROCÉDÉS DE SYNTHÈSE DE QUINOLÉINES ET COMPOSITIONS PHARMACEUTIQUES LES INCLUANT (PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Patent: 19498
Patent: PROCÉDÉS DE PRÉPARATION DE COMPOSÉS DE QUINOLÉINE ET COMPOSITIONS PHARMACEUTIQUES CONTENANT CES COMPOSÉS (PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Georgia, Republic of

Patent: 0217235
Patent: PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 57574
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 7848
Patent: תהליכים להכנת תרכובות קווינולין ותכשירי רוקחות המכילים תרכובות כאלה (Processes for preparting quinoline compounds and pharmaceutical compositions containing such compounds)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 13598
Estimated Expiration: ⤷  Sign Up

Patent: 14505109
Estimated Expiration: ⤷  Sign Up

Patent: 16188216
Patent: キノリン化合物およびそのような化合物を含有する医薬組成物の調製方法 (PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 13009116
Patent: PROCESOS PARA PREPARAR COMPUESTOS DE QUINOLINA Y COMPOSICIONES FARMACEUTICAS QUE CONTIENEN TALES COMPUESTOS. (PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS.)
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 4130
Patent: Processes for preparing quinoline compounds and pharmaceutical compositions containing such compounds
Estimated Expiration: ⤷  Sign Up

Patent: 2808
Patent: Processes for preparing quinoline compounds and pharmaceutical compositions containing such compounds
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 73262
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 73262
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1306072
Patent: PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 2030447
Estimated Expiration: ⤷  Sign Up

Patent: 140044782
Patent: PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS
Estimated Expiration: ⤷  Sign Up

Patent: 190049907
Patent: 퀴놀린 화합물들의 제조 방법들 및 상기 화합물들을 함유하는 약학 조성물들 (PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Patent: 200031711
Patent: 퀴놀린 화합물들의 제조 방법들 및 상기 화합물들을 함유하는 약학 조성물들 (PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Patent: 210010671
Patent: 퀴놀린 화합물들의 제조 방법들 및 상기 화합물들을 함유하는 약학 조성물들 (PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Patent: 210147117
Patent: 퀴놀린 화합물들의 제조 방법들 및 상기 화합물들을 함유하는 약학 조성물들 (PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Patent: 230158644
Patent: 퀴놀린 화합물들의 제조 방법들 및 상기 화합물들을 함유하는 약학 조성물들 (PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 05571
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 40509
Estimated Expiration: ⤷  Sign Up

Patent: 1309650
Patent: Processes for preparing quinoline compounds and pharmaceutical compositions containing such compounds
Estimated Expiration: ⤷  Sign Up

Patent: 1706249
Patent: Processes for preparing quinoline compounds and pharmaceutical compositions containing such compounds
Estimated Expiration: ⤷  Sign Up

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 COMETRIQ around the world.

Country Patent Number Title Estimated Expiration
New Zealand 594594 MALATE SALT OF N-(4-{ [6,7-BIS(METHYLOXY)QUINOLIN-4-YL]OXY} PHENYL)-N'-(4-FLUOROPHENYL)CYCLOPROPANE-1,1-DICARBOXAMIDE, AND CRYSTALLINE FORMS THEREOF FOR THE TREATMENT OF CANCER ⤷  Sign Up
Spain 2436888 ⤷  Sign Up
Taiwan 201437199 Method for preparing N-(4-{[6,7-bis(methyloxy)quinolin-4-yl]oxy}phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide ⤷  Sign Up
Georgia, Republic of P20217235 PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS ⤷  Sign Up
China 106083714 N‑(4‑{[6,7‑双(甲基氧基)喹啉‑4‑基]氧基}苯基)‑N′‑(4‑氟苯基)环丙烷‑1,1‑二甲酰胺苹果酸盐及其结晶型 ((L)-Malate salt of N-(4-phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide) ⤷  Sign Up
Taiwan 201706249 Processes for preparing quinoline compounds and pharmaceutical compositions containing such compounds ⤷  Sign Up
European Patent Office 2673262 PROCÉDÉS DE SYNTHÈSE DE QUINOLÉINES ET COMPOSITIONS PHARMACEUTIQUES LES INCLUANT (PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for COMETRIQ

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2213661 132014902289810 Italy ⤷  Sign Up PRODUCT NAME: CABOZANTINIB(COMETRIQ); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/890/001,002,003, 20140326
2213661 CR 2014 00039 Denmark ⤷  Sign Up PRODUCT NAME: CABOZANTINIB, INKLUSIVE FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER CABOZANTINIB (S)-MALAT; REG. NO/DATE: EU/1/13/890/001-003 20140326
2213661 C20140029 00117 Estonia ⤷  Sign Up PRODUCT NAME: KABOSANTINIIB;REG NO/DATE: K(2014)2043 (LOPLIK) 26.03.2014
2213661 300678 Netherlands ⤷  Sign Up PRODUCT NAME: CABOZANTINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/890/001-003 20140326
2213661 43/2014 Austria ⤷  Sign Up PRODUCT NAME: CABOZANTINIB ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/890/001-003 (MITTEILUNG) 20140326
2213661 122014000091 Germany ⤷  Sign Up 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 CA 2014 00039 Denmark ⤷  Sign Up PRODUCT NAME: CABOZANTINIB, INKLUSIVE FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER CABOZANTINIB (S)-MALAT; REG. NO/DATE: EU/1/13/890/001-003 20140321
>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.