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NDA

BRIVARACETAM | N205837 | 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

No clinical trials found on ClinicalTrials.gov for this drug

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 -14	View Letter (PDF)
May 18, 2023	SUPPL -11	View Letter (PDF)
Sep 3, 2021	SUPPL -9	View Letter (PDF)
Aug 31, 2021	SUPPL -7	View Letter (PDF)
May 16, 2018	SUPPL -4	View Letter (PDF)
Sep 19, 2017	SUPPL -3	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 — 50MG/5ML (10MG/ML)

RLDAP

1 patent0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: May 12, 2016

Patents (1)

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