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-four 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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Summary for CABOMETYX
International Patents: | 234 |
US Patents: | 10 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 76 |
Clinical Trials: | 84 |
Patent Applications: | 1,243 |
Drug Prices: | Drug price information for CABOMETYX |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CABOMETYX |
What excipients (inactive ingredients) are in CABOMETYX? | CABOMETYX excipients list |
DailyMed Link: | CABOMETYX at DailyMed |


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
Sponsor | Phase |
---|---|
Jun Zhang, MD, PhD | Phase 2 |
Kura Oncology, Inc. | Phase 1 |
Mirati Therapeutics Inc. | Phase 1 |
Pharmacology for CABOMETYX
Drug Class | Kinase 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 twenty US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of CABOMETYX is ⤷ Try for Free.
This potential generic entry date is based on patent ⤷ Try for Free.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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 | ⤷ Try for Free | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Exelixis Inc | CABOMETYX | cabozantinib s-malate | TABLET;ORAL | 208692-002 | Apr 25, 2016 | RX | Yes | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Exelixis Inc | CABOMETYX | cabozantinib s-malate | TABLET;ORAL | 208692-003 | Apr 25, 2016 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Exelixis Inc | CABOMETYX | cabozantinib s-malate | TABLET;ORAL | 208692-003 | Apr 25, 2016 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
>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 | 208692-002 | Apr 25, 2016 | ⤷ Try for Free | ⤷ Try for Free |
Exelixis Inc | CABOMETYX | cabozantinib s-malate | TABLET;ORAL | 208692-003 | Apr 25, 2016 | ⤷ Try for Free | ⤷ Try for Free |
Exelixis Inc | CABOMETYX | cabozantinib s-malate | TABLET;ORAL | 208692-001 | Apr 25, 2016 | ⤷ Try for Free | ⤷ Try for Free |
>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: ⤷ Try for Free
Australia
Patent: 12214322
Patent: Processes for preparing quinoline compounds and pharmaceutical compositions containing such compounds
Estimated Expiration: ⤷ Try for Free
Patent: 17204877
Patent: PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS
Estimated Expiration: ⤷ Try for Free
Patent: 19203745
Patent: PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS
Estimated Expiration: ⤷ Try for Free
Patent: 20273307
Patent: PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS
Estimated Expiration: ⤷ Try for Free
Patent: 22246429
Patent: PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS
Estimated Expiration: ⤷ Try for Free
Patent: 24205231
Patent: PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS
Estimated Expiration: ⤷ Try for Free
Brazil
Patent: 2013020362
Patent: processos para a preparação de compostos de quinolina, compostos e combinações farmacêuticas que os contem
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
China
Patent: 3459373
Patent: Processes for preparing quinoline compounds and pharmaceutical compositions containing such compounds
Estimated Expiration: ⤷ Try for Free
Denmark
Patent: 73262
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
Patent: 1391145
Patent: СПОСОБЫ ПОЛУЧЕНИЯ ХИНОЛИНОВЫХ СОЕДИНЕНИЙ И ФАРМАЦЕВТИЧЕСКИХ КОМПОЗИЦИЙ, СОДЕРЖАЩИХ ТАКИЕ СОЕДИНЕНИЯ
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
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: ⤷ Try for Free
Georgia, Republic of
Patent: 0217235
Patent: PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS
Estimated Expiration: ⤷ Try for Free
Patent: 0247677
Patent: PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS
Estimated Expiration: ⤷ Try for Free
Hungary
Patent: 57574
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
Japan
Patent: 13598
Estimated Expiration: ⤷ Try for Free
Patent: 14505109
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
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: ⤷ Try for Free
New Zealand
Patent: 4130
Patent: Processes for preparing quinoline compounds and pharmaceutical compositions containing such compounds
Estimated Expiration: ⤷ Try for Free
Patent: 2808
Patent: Processes for preparing quinoline compounds and pharmaceutical compositions containing such compounds
Estimated Expiration: ⤷ Try for Free
Poland
Patent: 73262
Estimated Expiration: ⤷ Try for Free
Portugal
Patent: 73262
Estimated Expiration: ⤷ Try for Free
South Africa
Patent: 1306072
Patent: PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS
Estimated Expiration: ⤷ Try for Free
South Korea
Patent: 2030447
Estimated Expiration: ⤷ Try for Free
Patent: 140044782
Patent: PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
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: ⤷ Try for Free
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: ⤷ Try for Free
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: ⤷ Try for Free
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: ⤷ Try for Free
Patent: 240170977
Patent: 퀴놀린 화합물들의 제조 방법들 및 상기 화합물들을 함유하는 약학 조성물들 (PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS)
Estimated Expiration: ⤷ Try for Free
Spain
Patent: 05571
Estimated Expiration: ⤷ Try for Free
Taiwan
Patent: 40509
Estimated Expiration: ⤷ Try for Free
Patent: 1309650
Patent: Processes for preparing quinoline compounds and pharmaceutical compositions containing such compounds
Estimated Expiration: ⤷ Try for Free
Patent: 1706249
Patent: Processes for preparing quinoline compounds and pharmaceutical compositions containing such compounds
Estimated Expiration: ⤷ Try for Free
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 |
---|---|---|---|
European Patent Office | 2392565 | Modulateurs de c-Met et procédés d'utilisation (c-Met modulators and methods of use) | ⤷ Try for Free |
China | 110818633 | 一种苹果酸盐及其晶型 (MALATE SALT AND CRYSTAL FORM THEREOF) | ⤷ Try for Free |
Spain | 2905571 | ⤷ Try for Free | |
Canada | 2758030 | 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) | ⤷ Try for Free |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CABOMETYX
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2213661 | 1490053-4 | Sweden | ⤷ Try for Free | PRODUCT NAME: CABOZANTINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/13/890 20140326 |
2213661 | CR 2014 00039 | Denmark | ⤷ Try for Free | 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 | ⤷ Try for Free | PRODUCT NAME: KABOSANTINIIB;REG NO/DATE: K(2014)2043 (LOPLIK) 26.03.2014 |
2213661 | C02213661/01 | Switzerland | ⤷ Try for Free | PRODUCT NAME: CABOZANTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66471 15.12.2017 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for CABOMETYX
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