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Last Updated: May 24, 2022

Details for New Drug Application (NDA): 205837


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NDA 205837 describes BRIVIACT, which is a drug marketed by Ucb Inc and is included in three NDAs. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the BRIVIACT profile page.

The generic ingredient in BRIVIACT is brivaracetam. One supplier is listed for this compound. Additional details are available on the brivaracetam profile page.
Summary for 205837
Tradename:BRIVIACT
Applicant:Ucb Inc
Ingredient:brivaracetam
Patents:1
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 205837
Generic Entry Date for 205837*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INTRAVENOUS

*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: 205837
Mechanism of ActionEpoxide Hydrolase Inhibitors
Suppliers and Packaging for NDA: 205837
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BRIVIACT brivaracetam SOLUTION;INTRAVENOUS 205837 NDA UCB, Inc. 50474-970 50474-970-75 10 VIAL, GLASS in 1 CARTON (50474-970-75) > 5 mL in 1 VIAL, GLASS (50474-970-63)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength50MG/5ML (10MG/ML)
Approval Date:May 12, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 27, 2024
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:See Plans and PricingPatent Expiration:Feb 21, 2026Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PARTIAL ONSET SEIZURES IN PATIENTS WITH EPILEPSY AGED 16 YEARS AND OLDER WITH EPILEPSY
Patent:See Plans and PricingPatent Expiration:Feb 21, 2026Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PARTIAL-ONSET SEIZURES AS ADJUNCTIVE THERAPY IN PATIENTS WITH EPILEPSY AGED 16 YEARS AND OLDER WITH EPILEPSY

Expired US Patents for NDA 205837

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ucb Inc BRIVIACT brivaracetam SOLUTION;INTRAVENOUS 205837-001 May 12, 2016 See Plans and Pricing See Plans and Pricing
Ucb Inc BRIVIACT brivaracetam SOLUTION;INTRAVENOUS 205837-001 May 12, 2016 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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