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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

54 trials from ClinicalTrials.gov, 44 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Earlier Intraocular Pressure Control After Ahmed Glaucoma Valve Implantation for Glaucoma NCT00869141	Phase 4	Completed	University of California, Los Angeles	52	2009-03 → 2013-03
Comparison of Intraocular Pressure (IOP)-Lowering Efficacy and Safety of AZORGA® Ophthalmic Suspension and COSOPT® Ophthalmic Solution NCT02325518	Phase 4	Completed	Alcon, a Novartis Company	218	2014-12 → 2015-12
Choroidal Thickness and Its Correlations With Ocular Parameters in Primary Open-angle Glaucoma NCT03966560	Phase 4	Completed	Afyon Kocatepe University Hospital	96	2014-01 → 2015-04
Circadian Ocular Perfusion Pressure and Ocular Blood Flow NCT00800540	Phase 4	Completed	Alcon Research	35	2009-02 → 2012-01
Efficacy and Tolerability of AZARGA® as Replacement Therapy in Patients on COMBIGAN® Therapy in Canada NCT01415401	Phase 4	Completed	Alcon Research	57	2011-09 → 2013-06
Effect of SIMBRINZA® Suspension as an Added Therapy to a Prostaglandin Analogue NCT01937312	Phase 4	Completed	Alcon Research	282	2013-10 → 2014-05
A Phase IV Study of Travoprost + Brinzolamide to Treat Glaucoma or Ocular Hypertension NCT00471380	Phase 4	Completed	Alcon Research	46	2007-03
Efficacy and Safety of Brinzolamide/Brimonidine Fixed Combination BID Compared to Brinzolamide BID Plus Brimonidine BID in Subjects With Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT)NCT02339584	Phase 3	Completed	Alcon Research	493	2015-04-14 → 2016-11-01
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
Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on Brimonidine 0.2%/Timolol 0.5% Fixed Combination Therapy (COMBIGAN®) in Latin America NCT01518244	Phase 4	Completed	Alcon Research	50	2011-12 → 2013-02

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 4 NDCs (2 brand, 2 generic)

Highest NADAC/Unit

$35.23

per ml

Lowest NADAC/Unit

$10.02

per ml

Brand NDCs

Generic NDCs

Avg Brand: $35.19

Avg Generic: $10.18

71% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
66758008585AZOPT 1% EYE DROPS	$35.23	ML	Brand	$10.33	2026-06-17
66758008570AZOPT 1% EYE DROPS	$35.15	ML	Brand	$10.02	2026-06-17
00781601485BRINZOLAMIDE 1% EYE DROPS	$10.33	ML	Generic	—	2026-06-17
00781601470BRINZOLAMIDE 1% EYE DROPS	$10.02	ML	Generic	—	2026-06-17

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
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
00781-6014-85BRINZOLAMIDE 1% SUSP,OPH	$59.80	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.