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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 205836


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NDA 205836 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 205836
Tradename:BRIVIACT
Applicant:Ucb Inc
Ingredient:brivaracetam
Patents:2
Pharmacology for NDA: 205836
Mechanism of ActionEpoxide Hydrolase Inhibitors
Suppliers and Packaging for NDA: 205836
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BRIVIACT brivaracetam TABLET;ORAL 205836 NDA UCB, Inc. 50474-370 50474-370-66 1 BOTTLE in 1 CARTON (50474-370-66) / 60 TABLET, FILM COATED in 1 BOTTLE
BRIVIACT brivaracetam TABLET;ORAL 205836 NDA UCB, Inc. 50474-470 50474-470-09 100 BLISTER PACK in 1 CARTON (50474-470-09) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:May 12, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 27, 2024
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:⤷  Try a TrialPatent Expiration:Apr 9, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Feb 21, 2026Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER

Expired US Patents for NDA 205836

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ucb Inc BRIVIACT brivaracetam TABLET;ORAL 205836-001 May 12, 2016 ⤷  Try a Trial ⤷  Try a Trial
Ucb Inc BRIVIACT brivaracetam TABLET;ORAL 205836-005 May 12, 2016 ⤷  Try a Trial ⤷  Try a Trial
Ucb Inc BRIVIACT brivaracetam TABLET;ORAL 205836-003 May 12, 2016 ⤷  Try a Trial ⤷  Try a Trial
Ucb Inc BRIVIACT brivaracetam TABLET;ORAL 205836-004 May 12, 2016 ⤷  Try a Trial ⤷  Try a Trial
Ucb Inc BRIVIACT brivaracetam TABLET;ORAL 205836-005 May 12, 2016 ⤷  Try a Trial ⤷  Try a Trial
Ucb Inc BRIVIACT brivaracetam TABLET;ORAL 205836-003 May 12, 2016 ⤷  Try a Trial ⤷  Try a Trial
Ucb Inc BRIVIACT brivaracetam TABLET;ORAL 205836-002 May 12, 2016 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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