CABOMETYX Drug Patent Profile
✉ Email this page to a colleague
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
Summary for CABOMETYX
International Patents: | 231 |
US Patents: | 10 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 76 |
Clinical Trials: | 81 |
Patent Applications: | 582 |
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 |
Children's Oncology Group | Phase 2/Phase 3 |
National Cancer Institute (NCI) | Phase 2/Phase 3 |
Pharmacology for CABOMETYX
Drug Class | Kinase Inhibitor |
Mechanism of Action | Protein Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for CABOMETYX
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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PATIENTS WITH HEPATOCELLULAR CARCINOMA (HCC) WHO HAVE BEEN PREVIOUSLY TREATED WITH SORAFENIB
C-Met modulator pharmaceutical compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
c-Met modulators and methods of use
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
C-met modulators and method of use
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF RENAL CELL CARCINOMA
C-met modulators and method of use
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF DIFFERENTIATED THYROID CANCER THAT HAS PROGRESSED FOLLOWING PRIOR VEGFR-TARGETED THERAPY
C-met modulator pharmaceutical compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting CABOMETYX
INDICATED FOR TREATMENT OF PATIENTS WITH HEPATOCELLULAR CARCINOMA (HCC) WHO HAVE BEEN PREVIOUSLY TREATED WITH SORAFENIB
Exclusivity Expiration: ⤷ Try a Trial
FOR THE TREATMENT OF PATIENTS WITH ADVANCED RENAL CELL CARCINOMA, AS A FIRST-LINE TREATMENT IN COMBINATION WITH NIVOLUMAB
Exclusivity Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
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: ⤷ Try a Trial
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: ⤷ Try a Trial
Australia
Patent: 12214322
Estimated Expiration: ⤷ Try a Trial
Patent: 17204877
Estimated Expiration: ⤷ Try a Trial
Patent: 19203745
Estimated Expiration: ⤷ Try a Trial
Patent: 20273307
Estimated Expiration: ⤷ Try a Trial
Patent: 22246429
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2013020362
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 26751
Estimated Expiration: ⤷ Try a Trial
China
Patent: 3459373
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 73262
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 3513
Estimated Expiration: ⤷ Try a Trial
Patent: 1391145
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 73262
Estimated Expiration: ⤷ Try a Trial
Patent: 19498
Estimated Expiration: ⤷ Try a Trial
Georgia, Republic of
Patent: 0217235
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 57574
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 7848
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 13598
Estimated Expiration: ⤷ Try a Trial
Patent: 14505109
Estimated Expiration: ⤷ Try a Trial
Patent: 16188216
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 13009116
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 4130
Estimated Expiration: ⤷ Try a Trial
Patent: 2808
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 73262
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 73262
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1306072
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 2030447
Estimated Expiration: ⤷ Try a Trial
Patent: 140044782
Estimated Expiration: ⤷ Try a Trial
Patent: 190049907
Estimated Expiration: ⤷ Try a Trial
Patent: 200031711
Estimated Expiration: ⤷ Try a Trial
Patent: 210010671
Estimated Expiration: ⤷ Try a Trial
Patent: 210147117
Estimated Expiration: ⤷ Try a Trial
Patent: 230158644
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 05571
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 40509
Estimated Expiration: ⤷ Try a Trial
Patent: 1309650
Estimated Expiration: ⤷ Try a Trial
Patent: 1706249
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
Taiwan | I516477 | ⤷ Try a Trial | |
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) | ⤷ Try a Trial |
Japan | 6342456 | ⤷ Try a Trial | |
European Patent Office | 2387563 | SEL DE MALATE DE N-(4-{[6,7-BIS(MÉTHYLOXY)QUINOLIN-4-YL]OXY}PHÉNYL)-N'-(4-FLUOROPHÉNYL)CYCLOPROPANE-1,1-DICARBOXAMIDE ET FORMES CRISTALLINES DE CELUI-CI POUR LE TRAITEMENT DU CANCER (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) | ⤷ Try a Trial |
Japan | 5185331 | ⤷ Try a Trial | |
South Africa | 201105167 | 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 | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CABOMETYX
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2213661 | 92508 | Luxembourg | ⤷ Try a 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 | 43/2014 | Austria | ⤷ Try a Trial | PRODUCT NAME: CABOZANTINIB ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/890/001-003 (MITTEILUNG) 20140326 |
2213661 | 300678 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: CABOZANTINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/890/001-003 20140326 |
2213661 | SPC/GB14/052 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: CABOZANTINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/13/890/001-006 20140326 |
2213661 | 122014000091 | Germany | ⤷ Try a 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 | C300678 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: CABOZANTINIB EN ELKE THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI, WAARONDER FARMACEUTISCH AANVAARDBARE ZOUTEN; REGISTRATION NO/DATE: EU/1/13/890/001-003 20140326 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |