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Last Updated: November 22, 2024

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CABOMETYX Drug Patent Profile


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

Cabometyx is a drug marketed by Exelixis Inc and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and thirty-one patent family members in thirty-two countries.

The generic ingredient in CABOMETYX 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 Cabometyx

Cabometyx 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 six 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 CABOMETYX
Drug Prices for CABOMETYX

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for CABOMETYX
Generic Entry Date for CABOMETYX*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;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 CABOMETYX

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

SponsorPhase
Jun Zhang, MD, PhDPhase 2
Mirati Therapeutics Inc.Phase 1
Kura Oncology, Inc.Phase 1

See all CABOMETYX clinical trials

Pharmacology for CABOMETYX
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Paragraph IV (Patent) Challenges for CABOMETYX
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
CABOMETYX Tablets cabozantinib s-malate 20 mg, 40 mg and 60 mg 208692 1 2019-08-16

US Patents and Regulatory Information for CABOMETYX

CABOMETYX is protected by fifteen US patents and four FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of CABOMETYX 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 CABOMETYX

C-met modulator pharmaceutical compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF PATIENTS WITH HEPATOCELLULAR CARCINOMA (HCC) WHO HAVE BEEN PREVIOUSLY TREATED WITH SORAFENIB

C-Met modulator pharmaceutical compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADVANCED RENAL CELL CARCINOMA

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: TREATMENT OF PATIENTS WITH HEPATOCELLULAR CARCINOMA (HCC) WHO HAVE BEEN PREVIOUSLY TREATED WITH SORAFENIB

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: TREATMENT OF RENAL CELL CARCINOMA

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: TREATMENT OF ADVANCED RENAL CELL CARCINOMA

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: TREATMENT OF DIFFERENTIATED THYROID CANCER THAT HAS PROGRESSED FOLLOWING PRIOR VEGFR-TARGETED THERAPY

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

C-met modulators and method of use
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF RENAL CELL CARCINOMA

C-met modulators and method of use
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF PATIENTS WITH HEPATOCELLULAR CARCINOMA (HCC) WHO HAVE BEEN PREVIOUSLY TREATED WITH SORAFENIB

C-met modulators and method of use
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADVANCED RENAL CELL CARCINOMA

(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: TREATMENT OF DIFFERENTIATED THYROID CANCER THAT HAS PROGRESSED FOLLOWING PRIOR VEGFR-TARGETED THERAPY

C-met modulator pharmaceutical compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting CABOMETYX

INDICATED FOR TREATMENT OF PATIENTS WITH HEPATOCELLULAR CARCINOMA (HCC) WHO HAVE BEEN PREVIOUSLY TREATED WITH SORAFENIB
Exclusivity Expiration: ⤷  Sign Up

FOR THE TREATMENT OF PATIENTS WITH ADVANCED RENAL CELL CARCINOMA, AS A FIRST-LINE TREATMENT IN COMBINATION WITH NIVOLUMAB
Exclusivity Expiration: ⤷  Sign Up

THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC DIFFERENTIATED THYROID CANCER (DTC) THAT HAS PROGRESSED FOLLOWING PRIOR VEGFR-TARGETED THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY OR INELIGIBLE
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC DIFFERENTIATED THYROID CANCER (DTC) THAT HAS PROGRESSED FOLLOWING PRIOR VEGFR-TARGETED THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY OR INELIGIBLE
Exclusivity 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 Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-002 Apr 25, 2016 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-003 Apr 25, 2016 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-003 Apr 25, 2016 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-003 Apr 25, 2016 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-002 Apr 25, 2016 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for CABOMETYX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-003 Apr 25, 2016 ⤷  Sign Up ⤷  Sign Up
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-001 Apr 25, 2016 ⤷  Sign Up ⤷  Sign Up
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-002 Apr 25, 2016 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for CABOMETYX

When does loss-of-exclusivity occur for CABOMETYX?

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 CABOMETYX around the world.

Country Patent Number Title Estimated Expiration
New Zealand 712808 Processes for preparing quinoline compounds and pharmaceutical compositions containing such compounds ⤷  Sign Up
Israel 227848 תהליכים להכנת תרכובות קווינולין ותכשירי רוקחות המכילים תרכובות כאלה (Processes for preparting quinoline compounds and pharmaceutical compositions containing such compounds) ⤷  Sign Up
European Patent Office 1673085 MODULATEURS DE C-MET ET PROCEDES D'UTILISATION (C-MET MODULATORS AND METHODS OF USE) ⤷  Sign Up
Japan 6931372 ⤷  Sign Up
Canada 2995880 SEL DE MALATE DE N-(4-{[6,7-BIS(METHYLOXY)QUINOLIN-4-YL]OXY}PHENYL-N'-( 4-FLUOROPHENYL)CYCLOPROPANE-1,1-DICARBOXAMIDE ET FORMES CRISTALLINES DE CELUI-CI POUR LE TRAITEMENT DU CANCER (MALATE SALT OF N-(4-{[6,7-BIS(METHYLOXY)QUIN0LIN-4-YL]OXY}PHENYL-N'-(4-FLUOROPHENYL)CYCLOPROPANE-1,1-DICARBOXAMIDE, AND CRYSTALLINE FORMS THEROF FOR THE TREATMENT OF CANCER) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CABOMETYX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 132014902289810 Italy ⤷  Sign Up PRODUCT NAME: CABOZANTINIB(COMETRIQ); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/890/001,002,003, 20140326
2213661 SPC/GB14/052 United Kingdom ⤷  Sign Up PRODUCT NAME: CABOZANTINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/13/890/001-006 20140326
2213661 C20140029 00117 Estonia ⤷  Sign Up PRODUCT NAME: KABOSANTINIIB;REG NO/DATE: K(2014)2043 (LOPLIK) 26.03.2014
2213661 C02213661/01 Switzerland ⤷  Sign Up PRODUCT NAME: CABOZANTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66471 15.12.2017
>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.