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Last Updated: September 25, 2022

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 eleven patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and thirty patent family members in thirty-four 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 three 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

See drug prices for CABOMETYX

DrugPatentWatch® Estimated Generic Entry Opportunity 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
Advanced Accelerator Applications SAPhase 1
Providence Health & ServicesPhase 1
Oregon Health and Science UniversityPhase 2

See all CABOMETYX clinical trials

Pharmacology for CABOMETYX
Drug ClassKinase Inhibitor
Mechanism of Action Protein 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 sixteen US patents and five FDA Regulatory Exclusivities.

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

C-met modulator pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PATIENTS WITH HEPATOCELLULAR CARCINOMA (HCC) WHO HAVE BEEN PREVIOUSLY TREATED WITH SORAFENIB

C-Met modulator pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DIFFERENTIATED THYROID CANCER THAT HAS PROGRESSED FOLLOWING PRIOR VEGFR-TARGETED THERAPY

Method of treating renal cell carcinoma using N-(4-(6,7-dimethoxyquinolin-4-yloxy)phenyl)-N'-(4-fluorophenyl)cyclopropa- ne-1,1-dicarboxamide, (2S)-hydroxybutanedioate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADVANCED RENAL CELL CARCINOMA (RCC) IN PATIENTS WHO HAVE RECEIVED PRIOR ANTI-ANGIOGENIC THERAPY

Processes for preparing quinoline compounds and pharmaceutical compositions containing such compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

c-Met modulators and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

C-met modulators and method of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF RENAL CELL CARCINOMA

C-met modulators and method of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DIFFERENTIATED THYROID CANCER THAT HAS PROGRESSED FOLLOWING PRIOR VEGFR-TARGETED THERAPY

C-met modulator pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting CABOMETYX

INDICATED FOR TREATMENT OF PATIENTS WITH HEPATOCELLULAR CARCINOMA (HCC) WHO HAVE BEEN PREVIOUSLY TREATED WITH SORAFENIB
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF PATIENTS WITH HEPATOCELLULAR CARCINOMA WHO HAVE BEEN PREVIOUSLY TREATED WITH SORAFENIB
Exclusivity Expiration: See Plans and Pricing

FOR THE TREATMENT OF PATIENTS WITH ADVANCED RENAL CELL CARCINOMA, AS A FIRST-LINE TREATMENT IN COMBINATION WITH NIVOLUMAB
Exclusivity Expiration: See Plans and Pricing

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: See Plans and Pricing

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: 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
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-002 Apr 25, 2016 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-002 Apr 25, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-003 Apr 25, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-003 Apr 25, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-003 Apr 25, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y 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 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
Estimated Expiration: See Plans and Pricing

Australia

Patent: 12214322
Estimated Expiration: See Plans and Pricing

Patent: 17204877
Estimated Expiration: See Plans and Pricing

Patent: 19203745
Estimated Expiration: See Plans and Pricing

Patent: 20273307
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2013020362
Estimated Expiration: See Plans and Pricing

Canada

Patent: 26751
Estimated Expiration: See Plans and Pricing

China

Patent: 3459373
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 73262
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 3513
Estimated Expiration: See Plans and Pricing

Patent: 1391145
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 73262
Estimated Expiration: See Plans and Pricing

Patent: 19498
Estimated Expiration: See Plans and Pricing

Georgia, Republic of

Patent: 0217235
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 57574
Estimated Expiration: See Plans and Pricing

Israel

Patent: 7848
Estimated Expiration: See Plans and Pricing

Japan

Patent: 13598
Estimated Expiration: See Plans and Pricing

Patent: 14505109
Estimated Expiration: See Plans and Pricing

Patent: 16188216
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 13009116
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 4130
Estimated Expiration: See Plans and Pricing

Patent: 2808
Estimated Expiration: See Plans and Pricing

Poland

Patent: 73262
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 73262
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1306072
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 2030447
Estimated Expiration: See Plans and Pricing

Patent: 140044782
Estimated Expiration: See Plans and Pricing

Patent: 190049907
Estimated Expiration: See Plans and Pricing

Patent: 200031711
Estimated Expiration: See Plans and Pricing

Patent: 210010671
Estimated Expiration: See Plans and Pricing

Patent: 210147117
Estimated Expiration: See Plans and Pricing

Spain

Patent: 05571
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 40509
Estimated Expiration: See Plans and Pricing

Patent: 1309650
Estimated Expiration: See Plans and Pricing

Patent: 1706249
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 CABOMETYX around the world.

Country Patent Number Title Estimated Expiration
China 103459373 Processes for preparing quinoline compounds and pharmaceutical compositions containing such compounds See Plans and Pricing
China 110818633 一种苹果酸盐及其晶型 (MALATE SALT AND CRYSTAL FORM THEREOF) See Plans and Pricing
Taiwan I641593 See Plans and Pricing
South Korea 102088588 See Plans and Pricing
Japan 4638436 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CABOMETYX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2213661 CR 2014 00039 Denmark See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: KABOSANTINIIB;REG NO/DATE: K(2014)2043 (LOPLIK) 26.03.2014
2213661 122014000091 Germany See Plans and Pricing 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 See Plans and Pricing 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 C 2014 036 Romania See Plans and Pricing PRODUCT NAME: CABOZANTINIB SI ORICE FORMA ECHIVALENTA TERAPEUTIC AACESTUIA, INCLUSIV SARURILE ACCEPT DATE OF NATIONAL AUTHORISATION: 20140321; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/890/001, EU/1/13/890/002, EU/1/13/890/003; DATE OF FIRST AUTHORISATION IN EEA: 20140321 ABILE FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: EU/1/13/890/001, EU/1/13/890/002, EU/1/13/890/003;
>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.