Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

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 six 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:6
Pharmacology for NDA: 208692
Mechanism of ActionProtein 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)
Paragraph IV (Patent) Challenges for 208692
Tradename Dosage Ingredient NDA Submissiondate
CABOMETYX TABLET;ORAL cabozantinib s-malate 208692 2019-08-16

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Apr 25, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 19, 2020
Regulatory Exclusivity Use:FOR THE TREATMENT OF PATIENTS WITH ADVANCED RENAL CELL CARCINOMA
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:Apr 25, 2019
Regulatory Exclusivity Use:NEW PRODUCT

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