Orange Book product · Brand (NDA)

PROLENSA

BROMFENAC SODIUM

Brand (NDA)NDA 203168TE ABRX BAUSCH AND LOMB

Apr 05, 2013

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 05, 2013
13 yr 5 mo ago
Today
Patent 10085958 expires
Listed drug product patent expiration.
Nov 19, 2032
in 6 yr 6 mo
Patent 9517220 expires
Listed method-of-use patent (U-1933) expiration.
Nov 11, 2033
in 7 yr 6 mo

Active ingredient

BROMFENAC SODIUM

Strength

EQ 0.07% ACID

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

Application

NDA 203168

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
10085958	Nov 19, 2032	in 6 yr 6 mo	Product
9517220	Nov 11, 2033	in 7 yr 6 mo	U-1933