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Serving leading biopharmaceutical companies globally:

Queensland Health
Boehringer Ingelheim
Federal Trade Commission

Generated: November 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203756

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NDA 203756 describes COMETRIQ, which is a drug marketed by Exelixis and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the COMETRIQ profile page.

The generic ingredient in COMETRIQ 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 203756


Pharmacology for NDA: 203756

Mechanism of ActionProtein Kinase Inhibitors

Suppliers and Packaging for NDA: 203756

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
cabozantinib s-malate
CAPSULE;ORAL 203756 NDA Exelixis, Inc. 42388-011 42388-011-14 4 BLISTER PACK in 1 CARTON (42388-011-14) > 1 KIT in 1 BLISTER PACK
cabozantinib s-malate
CAPSULE;ORAL 203756 NDA Exelixis, Inc. 42388-012 42388-012-14 4 BLISTER PACK in 1 CARTON (42388-012-14) > 1 KIT in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 20MG BASE
Approval Date:Nov 29, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 29, 2017
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Nov 29, 2019
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Patent:► SubscribePatent Expiration:Aug 14, 2026Product Flag?YSubstance Flag?YDelist Request?

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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Farmers Insurance
US Department of Justice
US Army
Queensland Health
Chinese Patent Office

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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