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CABOMETYX Drug 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 six patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and sixty-nine 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.
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 October 8, 2030. This may change due to patent challenges or generic licensing.
There have been two 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: | 169 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 57 |
| Clinical Trials: | 55 |
| Patent Applications: | 1 |
| 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 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
| Sponsor | Phase |
|---|---|
| Emory University | Phase 1 |
| Asan Medical Center | Phase 2 |
| Merck Sharp & Dohme Corp. | Phase 3 |
Pharmacology for CABOMETYX
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Protein Kinase Inhibitors |
ATC Classes for CABOMETYX
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 | Try Before You Buy | Try Before You Buy | Try Before You Buy | ||||
| Exelixis Inc | CABOMETYX | cabozantinib s-malate | TABLET;ORAL | 208692-003 | Apr 25, 2016 | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Y | Y | Try Before You Buy | ||
| Exelixis Inc | CABOMETYX | cabozantinib s-malate | TABLET;ORAL | 208692-003 | Apr 25, 2016 | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Try Before You Buy | ||||
| Exelixis Inc | CABOMETYX | cabozantinib s-malate | TABLET;ORAL | 208692-003 | Apr 25, 2016 | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Y | Try Before You Buy | |||
| >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 |
|---|---|---|
| Taiwan | 201036948 | Try Before You Buy |
| Taiwan | 201546049 | Try Before You Buy |
| Slovenia | 2387563 | Try Before You Buy |
| Australia | 2016262732 | Try Before You Buy |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for CABOMETYX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2213661 | 92508 | Luxembourg | Try Before You Buy | 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 | 300678 | Netherlands | Try Before You Buy | PRODUCT NAME: CABOZANTINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/890/001-003 20140326 |
| 2213661 | C02213661/01 | Switzerland | Try Before You Buy | PRODUCT NAME: CABOZANTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66471 15.12.2017 |
| 2213661 | 43/2014 | Austria | Try Before You Buy | 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 |
