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Last Updated: October 6, 2022

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 seven patents protecting this drug. Additional details are available on the COMETRIQ profile page.

The generic ingredient in COMETRIQ 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 203756
Tradename:COMETRIQ
Applicant:Exelixis
Ingredient:cabozantinib s-malate
Patents:7
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 203756
Generic Entry Date for 203756*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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: 203756
Mechanism of Action Protein Kinase Inhibitors
Suppliers and Packaging for NDA: 203756
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COMETRIQ 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
COMETRIQ 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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 20MG BASE
Approval Date:Nov 29, 2012TE:RLD:Yes
Patent:See Plans and PricingPatent Expiration:Jan 15, 2030Product Flag?Substance Flag?YDelist Request?
Patent:See Plans and PricingPatent Expiration:Jan 15, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:See Plans and PricingPatent Expiration:Jan 15, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING MEDULLARY THYROID CANCER

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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 verification 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.