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Last Updated: October 6, 2022

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 eleven 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.
Summary for 208692
Tradename:CABOMETYX
Applicant:Exelixis Inc
Ingredient:cabozantinib s-malate
Patents:11
DrugPatentWatch® Estimated Generic Entry Opportunity 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:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Apr 25, 2016TE: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

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