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Last Updated: December 3, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 212839


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NDA 212839 describes XCOPRI, which is a drug marketed by Sk Life and is included in one NDA. There is one patent protecting this drug. Additional details are available on the XCOPRI profile page.

The generic ingredient in XCOPRI is cenobamate. Additional details are available on the cenobamate profile page.
Summary for 212839
Tradename:XCOPRI
Applicant:Sk Life
Ingredient:cenobamate
Patents:1
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 212839
Generic Entry Date for 212839*:
Constraining patent/regulatory exclusivity:
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.

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG
Approval Date:Mar 10, 2020TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 10, 2025
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:⤷  Try it FreePatent Expiration:Oct 30, 2027Product Flag?Substance Flag?YDelist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Mar 10, 2020TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 10, 2025
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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