Orange Book product · Brand (NDA)

FYCOMPA

PERAMPANEL

Brand (NDA)NDA 208277TE ABRX CATALYST PHARMS

Apr 29, 2016

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 29, 2016
10 yr 3 mo ago
Today
Patent 8772497 expires
Listed drug substance patent expiration.
Jul 01, 2026
in 12 d

Active ingredient

PERAMPANEL

Strength

0.5MG/ML

Dosage form

SUSPENSION

Route

ORAL

TE code

Application

NDA 208277

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
8772497	Jul 01, 2026	in 12 d	Substance