Orange Book product · Brand (NDA)

TIGLUTIK KIT

RILUZOLE

Brand (NDA)NDA 209080TE ABRX ITALFARMACO SA

Sep 05, 2018

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Sep 05, 2018
7 yr 11 mo ago
Today
Patent 8765150 expires
Listed drug product patent expiration.
Mar 12, 2029
in 2 yr 9 mo

Active ingredient

RILUZOLE

Strength

50MG/10ML

Dosage form

SUSPENSION

Route

ORAL

TE code

Application

NDA 209080

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
8765150	Mar 12, 2029	in 2 yr 9 mo	ProductU-2401