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.

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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-003	Apr 25, 2016	⤷ Sign Up	⤷ Sign Up
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-001	Apr 25, 2016	⤷ Sign Up	⤷ Sign Up
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-002	Apr 25, 2016	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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