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AZOPT

NDA

BRINZOLAMIDE | N020816 | SANDOZ INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

14 trials from ClinicalTrials.gov, 10 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
The Effects of the Water Drinking Test on Intraocular Pressure NCT01507584	N/A	Completed	University of California, San Diego	23	2011-08 → 2013-04-30
Topical Brinzolamide Ophthalmic Suspension Versus Placebo in the Treatment of Infantile Nystagmus Syndrome NCT01312402	Phase 4	Completed	Akron Children's Hospital	5	2011-01 → 2014-03
Study of Brinzolamide and Timolol When Added to Travoprost in Primary Open-angle Glaucoma or Ocular Hypertension NCT00372827	Phase 4	Completed	Alcon Research	245	2004-02 → 2006-01
Study of the Intraocular Pressure (IOP)-Lowering Efficacy of Azopt 1.0% Compared to Timolol 0.5% in Patients With Glaucoma or Ocular Hypertension NCT00300079	Phase 4	Completed	Alcon Research	30	2006-09 → 2007-09
To Compare the Safety and Efficacy of Perrigo's Product to an FDA Approved Product for the Treatment of Glaucoma or Ocular Hypertension in Both Eyes NCT04024072	Phase 3	Completed	Padagis LLC	495	2019-06-24 → 2020-04-30
Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt NCT01722604	Phase 3	Completed	Bausch & Lomb Incorporated	258	2012-01 → 2012-09
6-Week Proof-of-Concept Study of Travoprost/Brinzolamide Ophthalmic Suspension in Subjects With Open-Angle Glaucoma or Ocular Hypertension NCT02140060	Phase 2	Completed	Alcon Research	327	2014-06 → 2014-11
Bioequivalence Study With Clinical Endpoint Comparing Brinzolamide 1% Ophthalmic Suspension to Azopt® 1% Ophthalmic Suspension In the Treatment of Chronic Open Angle Glaucoma or Ocular Hypertension in Both Eyes NCT02512042	Phase 3	Completed	Actavis Inc.	973	2015-04 → 2016-05
Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt NCT03896633	Phase 1/2	Completed	Bausch & Lomb Incorporated	637	2018-02-28 → 2018-11-17
IOP Lowering Efficacy of Travoprost/Brinzolamide Fixed Combination Ophthalmic Suspension in Patients With Open-Angle Glaucoma or Ocular Hypertension NCT00527501	Phase 2	Completed	Alcon Research	136	2007-08 → 2007-12

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 4 NDCs (2 brand, 2 generic)

Highest NADAC/Unit

$35.25

per ml

Lowest NADAC/Unit

$7.95

per ml

Brand NDCs

Generic NDCs

Avg Brand: $35.17

Avg Generic: $8.18

77% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
66758008585AZOPT 1% EYE DROPS	$35.25	ML	Brand	$8.41	2026-10-21
66758008570AZOPT 1% EYE DROPS	$35.09	ML	Brand	$7.95	2026-10-21
00781601485BRINZOLAMIDE 1% EYE DROPS	$8.41	ML	Generic	—	2026-10-21
00781601470BRINZOLAMIDE 1% EYE DROPS	$7.95	ML	Generic	—	2026-10-21

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (4 FSS)

Lowest Price

$59.80

Highest Price

$412.29

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00781-6014-70BRINZOLAMIDE 1% SUSP,OPH	$67.30	FSS	Sandoz, Inc.	08/14/2028
00781-6014-85BRINZOLAMIDE 1% SUSP,OPH	$59.80	FSS	Sandoz, Inc.	08/14/2028
66758-0085-70AZOPT 1% SOLN OPH	$274.61	FSS	Sandoz, Inc.	08/14/2028
66758-0085-85AZOPT 1% SOLN OPH	$412.29	FSS	Sandoz, Inc.	08/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Azopt (2024)

Total Spending

$14.5M

Total Claims

30,493

Beneficiaries

8,968

Avg Cost/Unit

$35.40

Spending Trend

$16.1M(2022)→$21.8M(2023)→$14.5M(2024)

YoY Change:-4.8%

5yr CAGR:-1.9%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain13 active DMFs3 inactive

10 active API suppliers hold Drug Master Files for this ingredient.

ICROM SRLBRINZOLAMIDE (MICRONIZED, MICRONIZED AND STERILE)

DMF 254782011

NEULAND LABORATORIES LTDBRINZOLAMIDE, USP

DMF 258172012

INDUSTRIALE CHIMICA SRLBRINZOLAMIDE, USP

DMF 259182012

NEULAND LABORATORIES LTDBRINZOLAMIDE USP (STERILE)

DMF 269362013

INDOCO REMEDIES LTDBRINZOLAMIDE USP

DMF 281342014

BIOCON LTDBRINZOLAMIDE USP (STERILIZED)

DMF 289332015

SCI PHARMTECH INCBRINZOLAMIDE

DMF 297462015

DUKE CHEM SABRINZOLAMIDE MICRONIZED USP

DMF 322022018

PHARMATHEN SABRINZOLAMIDE

DMF 341672019

NEULAND LABORATORIES LTDBRINZOLAMIDE USP (PROCESS-II)

DMF 364522023

FDC LTDBRINZOLAMIDE USP

DMF 395122024

NEULAND LABORATORIES LTDBRINZOLAMIDE (PROCESS-II, STERILE)

DMF 399202024

MICRO LABS LTDBRINZOLAMIDE USP

DMF 405662024

VIWIT PHARMACEUTICAL CO LTDInactiveBRINZOLAMIDE USP

DMF 228512009

ALP PHARM BEIJING CO LTDInactiveBRINZOLAMIDE USP (DRUG SUBSTANCE, NON-STERILE)

DMF 237892010

BACHEM SAInactiveBRINZOLAMIDE

DMF 253242011

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Jun 29, 2023	SUPPL -25	View Letter (PDF)
Jun 24, 2021	SUPPL -23	View Letter (PDF)
Nov 13, 2015	SUPPL -19	View Letter (PDF)
Mar 10, 2011	SUPPL -12	View Letter (PDF)
Oct 2, 2006	SUPPL -9	View Letter (PDF)
Jul 28, 2003	SUPPL -6	View Letter (PDF)
Apr 1, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1%

RLDAB

0 patents0 exclusivities▴

SUSPENSION/DROPS;OPHTHALMIC | Approved: Apr 1, 1998

No patent or exclusivity listings for this strength.