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CABOMETYX Drug Profile
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» See Plans and PricingWhich 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 six patents protecting this drug.
This drug has one hundred and sixty-five patent family members in twenty-nine 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.
US ANDA Litigation and Generic Entry Outlook for Cabometyx
Cabometyx was eligible for patent challenges on November 29, 2016.
There has been one patent litigation case 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: | 165 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 53 |
| Clinical Trials: | 47 |
| Patent Applications: | 1 |
| Drug Prices: | Drug price information for CABOMETYX |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CABOMETYX |
| DailyMed Link: | CABOMETYX at DailyMed |
Recent Clinical Trials for CABOMETYX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Washington University School of Medicine | Phase 2 |
| Hoffmann-La Roche | Phase 3 |
| Genentech, Inc. | Phase 2 |
Pharmacology for CABOMETYX
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Protein Kinase Inhibitors |
Paragraph IV (Patent) Challenges for CABOMETYX
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| CABOMETYX | TABLET;ORAL | cabozantinib s-malate | 208692 | 2019-08-16 |
US Patents and Regulatory Information for CABOMETYX
| 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 | 208692-003 | Apr 25, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Exelixis Inc | CABOMETYX | cabozantinib s-malate | TABLET;ORAL | 208692-003 | Apr 25, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Exelixis Inc | CABOMETYX | cabozantinib s-malate | TABLET;ORAL | 208692-003 | Apr 25, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Exelixis Inc | CABOMETYX | cabozantinib s-malate | TABLET;ORAL | 208692-003 | Apr 25, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Exelixis Inc | CABOMETYX | cabozantinib s-malate | TABLET;ORAL | 208692-001 | Apr 25, 2016 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Exelixis Inc | CABOMETYX | cabozantinib s-malate | TABLET;ORAL | 208692-002 | Apr 25, 2016 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| >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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Poland | 2387563 | Start Trial |
| Argentina | 075025 | Start Trial |
| Japan | 2015096543 | Start Trial |
| Eurasian Patent Organization | 201300146 | Start Trial |
| Mexico | 350898 | Start Trial |
| Japan | 2014055190 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for CABOMETYX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2213661 | C 2014 036 | Romania | Start Trial | PRODUCT NAME: CABOZANTINIB SI ORICE FORMA ECHIVALENTA TERAPEUTIC AACESTUIA, INCLUSIV SARURILE ACCEPTABILE FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: EU/1/13/890/001, EU/1/13/890/002, EU/1/13/890/003; 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 |
| 2213661 | C20140029 00117 | Estonia | Start Trial | PRODUCT NAME: KABOSANTINIIB;REG NO/DATE: K(2014)2043 (LOPLIK) 26.03.2014 |
| 2213661 | 92508 | Luxembourg | Start 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 | 583 | Finland | Start Trial | |
| 2213661 | PA2014033,C2213661 | Lithuania | Start Trial | PRODUCT NAME: KABOZANTINIBAS IR JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS; REGISTRATION NO/DATE: EU/1/13/890/001 - EU/1/13/890/003 20140321 |
| 2213661 | 300678 | Netherlands | Start Trial | PRODUCT NAME: CABOZANTINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/890/001-003 20140326 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
