Viewing data from:

COSOPT

NDA

DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE | N020869 | 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

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Brimonidine Tartrate / Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension NCT01284166	Phase 3	Withdrawn	Allergan	—	2013-07 → 2014-05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

$23.21

per ml

Lowest NADAC/Unit

$23.21

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
82584060510COSOPT EYE DROPS	$23.21	ML	Brand	$0.9164	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

$155.18

Highest Price

$155.18

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
82584-0605-10COSOPT	$155.18	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 (2024)

Total Spending

$634K

Total Claims

1,932

Beneficiaries

758

Avg Cost/Unit

$22.37

Spending Trend

$110K(2019)→$548K(2020)→$589K(2021)→$596K(2022)→$384K(2023)→$634K(2024)

YoY Change:+3.4%

5yr CAGR:+3.4%

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

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Nov 25, 2020	SUPPL -42	View Letter (PDF)
Aug 3, 2015	SUPPL -40	View Letter (PDF)
Jun 22, 2010	SUPPL -36	View Letter (PDF)
Oct 23, 2008	SUPPL -34	View Letter (PDF)
Aug 14, 2006	SUPPL -30	View Letter (PDF)
May 1, 2006	SUPPL -28	View Letter (PDF)
May 1, 2006	SUPPL -26	View Letter (PDF)
Dec 15, 2005	SUPPL -22	View Letter (PDF)
Mar 30, 2005	SUPPL -20	View Letter (PDF)
Apr 23, 2002	SUPPL -12	View Letter (PDF)
Apr 7, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 2% BASE;EQ 0.5% BASE

RLDAT1

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Apr 7, 1998

No patent or exclusivity listings for this strength.