Orange Book product · Brand (NDA)

BRIVIACT

BRIVARACETAM

Brand (NDA)NDA 205836TE ABRX UCB INC

May 12, 2016

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
May 12, 2016
10 yr 3 mo ago
Patent 6911461 expires
Listed drug substance patent expiration.
Feb 21, 2026
4 mo ago
Today
Patent 10729653 expires
Listed drug product patent expiration.
Apr 09, 2030
in 3 yr 10 mo

Active ingredient

BRIVARACETAM

Strength

10MG

Dosage form

TABLET

Route

ORAL

TE code

Application

NDA 205836

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
6911461	Feb 21, 2026	4 mo ago	SubstanceProductU-2295
10729653	Apr 09, 2030	in 3 yr 10 mo	Product