Is there a generic for Brinzolamide?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Brinzolamide, referencing the brand AZOPT. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Brinzolamide?

AZOPT (NDA 020816, SANDOZ) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Brinzolamide are approved?

Brinzolamide is approved in the following dosage form: suspension/drops.

FDA Orange Book · active-ingredient family

Brinzolamide

Brinzolamide is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:AZOPT · NDA 020816

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · suspension/drops

Product	Applicant	Application	TE	Approved
AZOPTRLD	SANDOZ	NDA 020816	AB	Apr 01, 1998

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
BRINZOLAMIDE	PADAGIS US	ANDA 211914	—	Jul 28, 2023
BRINZOLAMIDE	BAUSCH AND LOMB	ANDA 204884	AB	Aug 18, 2021
BRINZOLAMIDE	WATSON LABS INC	ANDA 209406	AB	Nov 27, 2020

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Brinzolamide — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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