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Fuji
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US Department of Justice
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Healthtrust

Generated: February 18, 2018

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 four patents protecting this drug. Additional details are available on the CABOMETYX profile page.

The generic ingredient in CABOMETYX is cabozantinib s-malate. There is one drug master file entry 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:4
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 E 42388-023-26
CABOMETYX cabozantinib s-malate TABLET;ORAL 208692 NDA Exelixis, Inc. 42388-024 E 42388-024-26

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:Apr 25, 2019
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Try a Free TrialPatent Expiration:Aug 14, 2026Product Flag?YSubstance Flag?YDelist Request?

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Mallinckrodt
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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