Orange Book product · Brand (NDA)

ILUVIEN

FLUOCINOLONE ACETONIDE

Brand (NDA)NDA 201923RX ALIMERA SCIENCES INC

Sep 26, 2014

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Sep 26, 2014
11 yr 11 mo ago
Today
Patent 8871241 expires
Listed drug product patent expiration.
Aug 12, 2027
in 1 yr 2 mo
Patent 9849027 expires
Listed drug product patent expiration.
Nov 07, 2028
in 2 yr 5 mo
Patent 9849027 expires
Listed drug product patent expiration.
Nov 07, 2028
in 2 yr 5 mo

Active ingredient

FLUOCINOLONE ACETONIDE

Strength

0.19MG

Dosage form

IMPLANT

Route

INTRAVITREAL

TE code

Not listed

Application

NDA 201923

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
8871241	Aug 12, 2027	in 1 yr 2 mo	Product
9849027	Nov 07, 2028	in 2 yr 5 mo	ProductU-708
9849027	Nov 07, 2028	in 2 yr 5 mo	ProductU-4157