CABOMETYX Drug Patent Profile
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When do Cabometyx patents expire, and when can generic versions of Cabometyx launch?
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
*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 ⤷ 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 | |||
| Exelixis Inc | CABOMETYX | cabozantinib s-malate | TABLET;ORAL | 208692-002 | Apr 25, 2016 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | 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 |
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: ⤷ Sign Up
Australia
Patent: 12214322
Estimated Expiration: ⤷ Sign Up
Patent: 17204877
Estimated Expiration: ⤷ Sign Up
Patent: 19203745
Estimated Expiration: ⤷ Sign Up
Patent: 20273307
Estimated Expiration: ⤷ Sign Up
Patent: 22246429
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2013020362
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 26751
Estimated Expiration: ⤷ Sign Up
China
Patent: 3459373
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 73262
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 3513
Estimated Expiration: ⤷ Sign Up
Patent: 1391145
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 73262
Estimated Expiration: ⤷ Sign Up
Patent: 19498
Estimated Expiration: ⤷ Sign Up
Georgia, Republic of
Patent: 0217235
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 57574
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 7848
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 13598
Estimated Expiration: ⤷ Sign Up
Patent: 14505109
Estimated Expiration: ⤷ Sign Up
Patent: 16188216
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 13009116
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 4130
Estimated Expiration: ⤷ Sign Up
Patent: 2808
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 73262
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 73262
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1306072
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2030447
Estimated Expiration: ⤷ Sign Up
Patent: 140044782
Estimated Expiration: ⤷ Sign Up
Patent: 190049907
Estimated Expiration: ⤷ Sign Up
Patent: 200031711
Estimated Expiration: ⤷ Sign Up
Patent: 210010671
Estimated Expiration: ⤷ Sign Up
Patent: 210147117
Estimated Expiration: ⤷ Sign Up
Patent: 230158644
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 05571
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 40509
Estimated Expiration: ⤷ Sign Up
Patent: 1309650
Estimated Expiration: ⤷ Sign Up
Patent: 1706249
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 |
|---|---|---|---|
| Denmark | 2213661 | ⤷ Sign Up | |
| Japan | 2017160270 | ｃ−Ｍｅｔモジュレーターおよびその使用 (c-Met MODULATOR AND ITS USE) | ⤷ Sign Up |
| South Korea | 102088588 | ⤷ Sign Up | |
| Brazil | PI1006812 | sal de malato de n-(4-{[6,7-bis(metiloxi)quinolin-4-il]fenil)-n-(4-fluorofenil)ciclopropane-1,1-dicarboxamida | ⤷ Sign Up |
| Slovenia | 2210607 | ⤷ Sign Up | |
| Israel | 224189 | תכשירי רוקחות מאפנני c-met (C-met modulator pharmaceutical compositions) | ⤷ 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 | 92508 | Luxembourg | ⤷ Sign Up | 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 | PA2014033 | Lithuania | ⤷ Sign Up | PRODUCT NAME: CABOZANTINIBUM; REGISTRATION NO/DATE: EU/1/13/890/001 - EU/1/13/890/003 20140321 |
| 2213661 | C300678 | Netherlands | ⤷ Sign Up | 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 |
| 2213661 | PA2014033,C2213661 | Lithuania | ⤷ Sign Up | PRODUCT NAME: KABOZANTINIBAS IR JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS; REGISTRATION NO/DATE: EU/1/13/890/001 - EU/1/13/890/003 20140321 |
| 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 | 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 |
| >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.
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