Orange Book product · Brand (NDA)

SIMBRINZA

BRIMONIDINE TARTRATE; BRINZOLAMIDE

Brand (NDA)NDA 204251RX ALCON LABS INC

Apr 19, 2013

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 19, 2013
13 yr 4 mo ago
Today
Patent 9421265 expires
Listed drug product patent expiration.
Jun 17, 2030
in 4 yr 1 mo
Patent 9044484 expires
Listed drug product patent expiration.
Oct 30, 2030
in 4 yr 5 mo

Active ingredient

BRIMONIDINE TARTRATE; BRINZOLAMIDE

Strength

0.2%;1%

Dosage form

SUSPENSION/DROPS

Route

OPHTHALMIC

TE code

Not listed

Application

NDA 204251

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
9421265	Jun 17, 2030	in 4 yr 1 mo	Product
9044484	Oct 30, 2030	in 4 yr 5 mo	Product