Brivaracetam

Treats partial-onset seizures. Sold as Briviact. Every FDA application for this active ingredient: 3 branded and 23 generic.

As of Nov 14, 2026, FDA lists 26 applications for Brivaracetam (sold as Briviact), first approved Feb 18, 2016, with 8 new uses approved and 0 published complete response letters.

First approved: Feb 18, 2016
Applications: 26
New uses approved: 8
Complete response letters: 0
Medicare spending, 2025: $262M
First approved in the EU: Jan 13, 2016
First approved in Japan: Jun 24, 2024

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Briviact	Part D	$262M	+19%	18,409
Brivaracetam	Part D	$0K	New	0

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

BRIVARACETAM 10 MG/ML ORAL SOL: $0.276 per MLGeneric · new this year
BRIVARACETAM 100 MG TABLET: $0.253 per unitGeneric · new this year
BRIVARACETAM 25 MG TABLET: $0.209 per unitGeneric · new this year
BRIVARACETAM 50 MG TABLET: $0.172 per unitGeneric · new this year
BRIVARACETAM 75 MG TABLET: $0.266 per unitGeneric · new this year
BRIVIACT 10 MG TABLET: $24.01 per unitBrand · +3% in a year
BRIVIACT 10 MG/ML ORAL SOLN: $4.81 per MLBrand · +2% in a year
BRIVIACT 100 MG TABLET: $24.07 per unitBrand · +2% in a year
BRIVIACT 25 MG TABLET: $24.05 per unitBrand · +3% in a year
BRIVIACT 50 MG TABLET: $24.07 per unitBrand · +3% in a year
BRIVIACT 75 MG TABLET: $24.05 per unitBrand · +2% in a year

Orphan Designations (FDA)

3 designations, 0 approved for the designated use; see all orphan designations

Treatment of Juvenile Absence EpilepsyUCB, Inc. · designated Dec 3, 2019
Treatment of Childhood Absence EpilepsyUCB, Inc. · designated Dec 3, 2019
Treatment of symptomatic myoclonusUCB Pharma, Inc. · designated Oct 5, 2005

Approvals in the EU (EMA)

First approved in the EU 1 month before the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Briviact (in Italy: Nubriveo), new substanceUCB Pharma SA · Jan 13, 2016

Approvals in Japan (PMDA)

First approved in Japan 100 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Briviact, new ingredient(1) (2) Drugs with a new active ingredient indicated for the treatment of partial seizures (including secondary generalized seizures) in patients with epilepsy. · UCB Japan Co., Ltd. · Jun 24, 2024

Clinical Trials

3 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


A Study to Test the Long-term Safety and Tolerability of Brivaracetam in Study Participants With Childhood Absence Epilepsy or Juvenile Absence EpilepsyChildhood Absence Epilepsy, Juvenile Absence Epilepsy · UCB Biopharma SRL	Phase 3	Active, not recruiting	Mar 18, 2024
Epileptic Hippocampus in Alzheimer's DiseaseAlzheimer Disease, Mild Cognitive Impairment · University of California, Los Angeles	Phase 1 / Phase 2	Not yet recruiting	Jun 12, 2023
A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With SeizuresEpilepsy · UCB Biopharma SRL	Phase 3	Recruiting	Jan 20, 2021

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Feb 18, 2016	BriviactNDA 205836 · New molecular entity	Ucb Inc	7	Marketed
Feb 18, 2016	BriviactNDA 205837 · New dosage form	Ucb Inc	7	Marketed
Feb 18, 2016	BriviactNDA 205838 · New dosage form	Ucb Inc	7	Marketed
Jun 9, 2022	BrivaracetamANDA 214748	Sunshine	2	Marketed
Oct 3, 2022	BrivaracetamANDA 214501	Zydus Pharms	0	Marketed
Dec 20, 2022	BrivaracetamANDA 214918	Lupin	1	Discontinued
Jan 6, 2023	BrivaracetamANDA 214848	Aurobindo Pharma Ltd	2	Marketed
Nov 13, 2025	BrivaracetamANDA 214921	Msn	0	Marketed
Feb 19, 2026	BrivaracetamANDA 214922	Msn	0	Marketed
Feb 23, 2026	BrivaracetamANDA 214875	Apotex	0	Marketed
Feb 23, 2026	BrivaracetamANDA 214880	Micro Labs	0	Marketed
Feb 23, 2026	BrivaracetamANDA 214924	Msn	0	Marketed
Feb 23, 2026	BrivaracetamANDA 218249	Hainan Poly	0	Marketed
Feb 23, 2026	BrivaracetamANDA 218494	Zhejiang Poly Pharm	0	Marketed
Feb 23, 2026	BrivaracetamANDA 219772	Alkem Labs Ltd	0	Marketed
Feb 23, 2026	BrivaracetamANDA 220164	Lupin	0	Marketed
Feb 23, 2026	BrivaracetamANDA 220385	Regcon Holdings	0	Marketed
Feb 23, 2026	BrivaracetamANDA 220470	Breckenridge	0	Discontinued
Jul 1, 2026	BrivaracetamANDA 219952	Sciegen Pharms	0	Marketed
Jul 13, 2026	BrivaracetamANDA 219766	Shandong	0	Marketed
Aug 10, 2026	BrivaracetamANDA 220288	Aurobindo Pharma	0	Marketed
Sep 8, 2026	BrivaracetamANDA 220136	Zhejiang Jutai Pharm	0	Marketed
Oct 20, 2026	BrivaracetamANDA 221301	Zydus Lifesciences	0	Marketed
Nov 6, 2026	BrivaracetamANDA 220832	Appco	0	Marketed
—	BrivaracetamANDA 214831	Annora Pharma	0	Discontinued
—	BrivaracetamANDA 219583	Shandong New Time Pharmaceutical Co Ltd	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA