Details for New Drug Application (NDA): 208692
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NDA 208692 describes CABOMETYX, which is a drug marketed by Exelixis Inc and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the CABOMETYX profile page.
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.
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.
Summary for 208692
| Tradename: | CABOMETYX |
| Applicant: | Exelixis Inc |
| Ingredient: | cabozantinib s-malate |
| Patents: | 10 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208692
Generic Entry Date for 208692*:
Constraining patent/regulatory exclusivity:
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.
Pharmacology for NDA: 208692
| Mechanism of Action | Protein Kinase Inhibitors |
Suppliers and Packaging for NDA: 208692
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CABOMETYX | cabozantinib s-malate | TABLET;ORAL | 208692 | NDA | Exelixis, Inc. | 42388-023 | 42388-023-26 | 30 TABLET in 1 BOTTLE (42388-023-26) |
| CABOMETYX | cabozantinib s-malate | TABLET;ORAL | 208692 | NDA | Exelixis, Inc. | 42388-023 | 42388-023-36 | 30 TABLET in 1 BOTTLE (42388-023-36) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Apr 25, 2016 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jan 22, 2024 | ||||||||
| Regulatory Exclusivity Use: | FOR THE TREATMENT OF PATIENTS WITH ADVANCED RENAL CELL CARCINOMA, AS A FIRST-LINE TREATMENT IN COMBINATION WITH NIVOLUMAB | ||||||||
| Regulatory Exclusivity Expiration: | Jan 14, 2026 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR TREATMENT OF PATIENTS WITH HEPATOCELLULAR CARCINOMA (HCC) WHO HAVE BEEN PREVIOUSLY TREATED WITH SORAFENIB | ||||||||
| Regulatory Exclusivity Expiration: | Sep 17, 2028 | ||||||||
| Regulatory Exclusivity Use: | 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 | ||||||||
Expired US Patents for NDA 208692
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Exelixis Inc | CABOMETYX | cabozantinib s-malate | TABLET;ORAL | 208692-001 | Apr 25, 2016 | ⤷ Subscribe | ⤷ Subscribe |
| Exelixis Inc | CABOMETYX | cabozantinib s-malate | TABLET;ORAL | 208692-002 | Apr 25, 2016 | ⤷ Subscribe | ⤷ Subscribe |
| Exelixis Inc | CABOMETYX | cabozantinib s-malate | TABLET;ORAL | 208692-003 | Apr 25, 2016 | ⤷ Subscribe | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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