Orange Book product · Brand (NDA)

BRIVIACT

BRIVARACETAM

Brand (NDA)NDA 205837TE APRX 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
Patent 6911461 expires
Listed drug substance patent expiration.
Feb 21, 2026
4 mo ago
Today

Active ingredient

BRIVARACETAM

Strength

50MG/5ML (10MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Application

NDA 205837

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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-1815
6911461	Feb 21, 2026	4 mo ago	SubstanceProductU-2130