Viewing data from:

COSOPT PF

NDA

DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE | N202667 | THEA PHARMA 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

8 trials from ClinicalTrials.gov, 7 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Effectiveness and Safety of Timolol and Dorzolamide Loaded Contact Lenses NCT02852057	Phase 1	Completed	University of Florida	2	2018-01-18 → 2021-08-10
A Study to Evaluate the Effectiveness of Cosopt® as First Line Therapy (MK-0507A-153)NCT00546286	Phase 3	Completed	Merck Sharp & Dohme LLC	170	2006-05-31 → 2007-08-23
Dry Eye Study With Cosopt® Over 8 Weeks in Patients With Open-Angle Glaucoma or Ocular Hypertension (0507A-152)(COMPLETED)NCT00545064	Phase 4	Completed	Merck Sharp & Dohme LLC	176	2007-05-23 → 2008-09-15
Comparison of the Effects of Two Glaucoma Drugs Over 24 Hours (0507A-137)(COMPLETED)NCT00108017	Phase 3	Completed	Merck Sharp & Dohme LLC	330	2005-04 → 2006-07
MK0507A Clinical Study in Patients With Glaucoma and Ocular Hypertension (0507A-149)(COMPLETED)NCT00449956	Phase 3	Completed	Merck Sharp & Dohme LLC	474	2007-03-12 → 2008-02-16
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
Comparing Effects of Two Fixed Combinations Ophthalmic Solutions on Ocular Blood Flow NCT00811850	Phase 4	Completed	Allergan	15	2008-12 → 2009-12
Safety and Efficacy of Triple Combination Therapy With Dorzolamide Hydrochloride / Brimonidine Tartrate / Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension NCT01284166	Phase 3	Withdrawn	Allergan	—	2013-07 → 2014-05

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$3.30

per ea

Lowest NADAC/Unit

$3.30

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
82584060430COSOPT PF EYE DROPS	$3.30	EA	Brand	$1.10	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 | 1 NDC (1 FSS)

Lowest Price

$129.75

Highest Price

$129.75

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
82584-0604-30COSOPT (PF)	$129.75	FSS	Thea Pharma, Inc.	01/31/2028

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

Medicare Part D Spending

CMS annual spending data for Cosopt PF (2024)

Total Spending

$4.5M

Total Claims

12,769

Beneficiaries

3,125

Avg Cost/Unit

$3.21

Spending Trend

$11.7M(2019)→$8.6M(2020)→$6.2M(2021)→$6.3M(2022)→$4.3M(2023)→$4.5M(2024)

YoY Change:-0.8%

5yr CAGR:-0.8%

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Apr 10, 2026	SUPPL -5	View Letter (PDF)
Feb 3, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 2% BASE;EQ 0.5% BASE

RLDAT2

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Feb 1, 2012

No patent or exclusivity listings for this strength.