Viewing data from:

BRIVIACT

NDA

BRIVARACETAM | N205838 | UCB INC

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Expired (1)Today

Today

6911461

Feb. 21, 2026

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
UCB, Inc. et al v. Annora Pharma Private Limited et al 1:2020cv00987 3 patentsANDA 214831, 214875, 214848, 214918, 214880, 214922, 214924, 214921, 214501brivaracetam	D. Del.	2020-07-24	Terminated 2023-09-12	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

35 trials from ClinicalTrials.gov, 30 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
This Trial, Evaluating the Long-term Safety and Tolerability of Brivaracetam Will Provide Subjects Suffering From Epilepsy, Who May Have Benefited From Brivaracetam as Adjunctive Treatment, the Opportunity to Receive Open Label Brivaracetam Treatment NCT00150800	Phase 3	Completed	UCB PHARMA Inc. (US)	668	2006-01 → 2017-09
Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures NCT00490035	Phase 3	Completed	UCB Pharma SA	399	2007-09 → 2009-02
A Dose-ranging Study With Brivaracetam in Patients From 16 to 65 Years With Refractory Partial Onset Seizures.NCT00175825	Phase 2	Completed	UCB Pharma	210	2005-11-07 → 2006-06-29
Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam in Subjects Suffering From Epilepsy NCT00175916	Phase 3	Completed	UCB Pharma	853	2005-09 → 2019-05
Comparison of Brivaracetam Oral Tablet (10 mg, 50 mg, 75 mg and 100 mg) and Brivaracetam Injection (100 mg) in Healthy Volunteers NCT01796899	Phase 1	Completed	UCB Pharma SA	25	2013-01 → 2013-03
A Brain Imaging Study With Positron Emission Tomography and the Radiotracer [11C]UCB-J to Estimate How Fast Brivaracetam and Levetiracetam Enter the Brain in Healthy Volunteers NCT02602860	Phase 1	Completed	UCB Pharma	13	2015-11 → 2017-09
A Study to Assess the Efficacy and Safety of Brivaracetam as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting NCT03021018	Phase 2	Completed	UCB Biopharma S.P.R.L.	46	2017-02-06 → 2018-04-27
A Study to Test the Safety/ Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment in Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization NCT03250377	Phase 3	Completed	UCB Biopharma SRL	207	2017-08-05 → 2024-12-24
Open-label Long-term Study of Adjunctive Brivaracetam in Pediatric Subjects With Epilepsy NCT01364597	Phase 3	Completed	UCB Pharma SA	257	2011-08-01 → 2022-02-03
Brivaracetam as add-on Treatment of Unverricht-Lundborg Disease in Adolescents and Adults NCT00357669	Phase 3	Completed	UCB Pharma SA	50	2006-11 → 2007-10

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$4.81

per ml

Lowest NADAC/Unit

$4.81

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
50474087015BRIVIACT 10 MG/ML ORAL SOLN	$4.81	ML	Brand	$0.2723	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$1086.45

Highest Price

$1355.13

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
50474-0870-15BRIVIACT 10MG/300ML ORAL SOL	$1355.13	FSS	UCB, Inc.	09/14/2030
50474-0870-15BRIVIACT 10MG/300ML ORAL SOL	$1086.45	Big4	UCB, Inc.	09/14/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain25 active DMFs

21 active API suppliers hold Drug Master Files for this ingredient.

MAITHRI LABORATORIES PRIVATE LTDBRIVARACETAM

DMF 337092019

RUYUAN HEC PHARM CO LTDBRIVARACETAM NON-STERILE BULK DRUG SUBSTANCE

DMF 343982020

LUPIN MANUFACTURING SOLUTIONS LTDBRIVARACETAM

DMF 344022019

ZYDUS LIFESCIENCES LTDBRIVARACETAM

DMF 344052019

AURISCO PHARMACEUTICAL CO LTDBRIVARACETAM

DMF 345112020

HONOUR LAB LTDBRIVARACETAM

DMF 345692020

MICRO LABS LTDBRIVARACETAM

DMF 345852020

SOLARA ACTIVE PHARMA SCIENCES LTDBRIVARACETAM

DMF 363042021

SHAOXING JINGXIN PHARMACEUTICAL CO LTDBRIVARACETAM

DMF 364092021

OPTIMUS DRUGS PRIVATE LTDBRIVARACETAM

DMF 366492022

AMI LIFESCIENCES PRIVATE LTDBRIVARACETAM

DMF 366552022

YANGZHOU AURISCO PHARMACEUTICAL CO LTDBRIVARACETAM

DMF 373292022

BEIJING HOPE PHARMACEUTICAL CO LTDBRIVARACETAM

DMF 375162022

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDBRIVARACETAM

DMF 375242022

CHENGDA PHARMACEUTICALS CO LTDBRIVARACETAM

DMF 378212023

ALIVUS LIFE SCIENCES LTDBRIVARACETAM

DMF 385972023

LEE PHARMA LTDBRIVARACETAM

DMF 390082023

YANGZHOU AURISCO PHARMACEUTICAL CO LTDBRIVARACETAM

DMF 403422024

APITORIA PHARMA PRIVATE LTDBRIVARACETAM

DMF 406782024

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDBRIVARACETAM (PROCESS II)

DMF 407612024

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDBRIVARACETAM

DMF 414912025

DIVIS LABORATORIES LTDBRIVARACETAM

DMF 415702025

AMI LIFESCIENCES PRIVATE LTDBRIVARACETAM (PROCESS-II)

DMF 419182025

ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTDBRIVARACETAM

DMF 425112025

HONOUR LAB LTDBRIVARACETAM (PROCESS-II)

DMF 425442025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Aug 29, 2025	SUPPL -15	View Letter (PDF)
May 18, 2023	SUPPL -11	View Letter (PDF)
Sep 3, 2021	SUPPL -8	View Letter (PDF)
Aug 31, 2021	SUPPL -6	View Letter (PDF)
May 16, 2018	SUPPL -3	View Letter (PDF)
Sep 19, 2017	SUPPL -2	View Letter (PDF)
Jun 6, 2016	SUPPL -1	View Letter (PDF)
Feb 19, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG/ML

RLDAA

1 patent0 exclusivities▴

SOLUTION;ORAL | Approved: May 12, 2016

Patents (1) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
6911461	Feb 21, 2026	—	Yes	Yes		—