Is Dorzolamide + Timolol registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 6 valid registrations of Dorzolamide + Timolol, including COSOPT EYE DROPS (2,0.5 %,%, Eye drops, solution, SAR 46.55); COSOPT PRESERVATIVE FREE EYE DROP (20,5 mg,mg, Eye drops, solution, SAR 134.05); Domito (2,0.5 %,%, Eye drops, solution, SAR 33.80); TWINZOL EYE DROPS (2,0.5 %,%, Eye drops, SAR 33.80); XOLAMOL EYE DROP (2,0.5 %,%, Eye drops, solution, SAR 39.55).

Is Dorzolamide + Timolol approved by the US FDA?

Drugs@FDA lists 22 application product lines for Dorzolamide + Timolol, including COSOPT (Prescription); DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (Prescription); DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (Prescription); DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (Prescription); DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (Prescription).

Active substances

Dorzolamide + Timolol

SFDA 8
US FDA 22
Health Canada 9
US price lines 3
NHS prices 4

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
COSOPT EYE DROPS	2,0.5 %,%	Eye drops, solution · Ocular use	1 Dropper Container	SAR 46.55	NCE · Prescription	MUNDIPHARMA PTY LTD	Valid
COSOPT PRESERVATIVE FREE EYE DROP	20,5 mg,mg	Eye drops, solution · Ocular use	60 Single Dose Container	SAR 134.05	NCE · Prescription	MUNDIPHARMA PTY LTD	Valid
Domito	2,0.5 %,%	Eye drops, solution · Ocular use	1 Dropper Container	SAR 33.80	Generic · Prescription	ADVANCED PHARMACEUTICAL FACTORY APF	Valid
TWINZOL EYE DROPS	2,0.5 %,%	Eye drops · Ophthalmic use	1 Bottle	SAR 33.80	Generic · Prescription	Orchidia Pharmaceutical Industries	Valid
XOLAMOL EYE DROP	2,0.5 %,%	Eye drops, solution · Ophthalmic use	1 Dropper Container	SAR 39.55	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
Xolamol	20,5 mg/ml,mg/ml	Eye drops, solution · Ocular use	30 Single Dose Container	SAR 63.65	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
COSOPT EYE DROPS	2, 0.5 %	Eye drops, solution · Ophthalmic use	1 Dropper Container	SAR 80.45	NCE · Prescription	MERCK SHARP & DOHME	Withdrawn by MAH · Not Marketed
DORZALOL EYE DROPS	2,0.5 %,%	Eye drops · Ophthalmic use	1 Dropper Container	SAR 35.60	Generic · Prescription	RIYADH PHARMA	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

OPEN ANGLE GLUCOMA

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
COSOPT	EQ 2% BASE;EQ 0.5% BASE	solution/drops · ophthalmic	THEA PHARMA	Prescription	7 Apr 1998
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	solution/drops · ophthalmic	RUBICON RESEARCH	Prescription	28 Oct 2008
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	solution/drops · ophthalmic	SANDOZ	Prescription	6 Nov 2008
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	solution/drops · ophthalmic	BAUSCH AND LOMB	Prescription	14 Jul 2009
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	solution/drops · ophthalmic	SANDOZ	Prescription	18 Nov 2009
COSOPT PF	EQ 2% BASE;EQ 0.5% BASE	solution/drops · ophthalmic	THEA PHARMA	Prescription	1 Feb 2012
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	solution/drops · ophthalmic	REGCON HOLDINGS	Prescription	3 Sep 2014
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	solution/drops · ophthalmic	EPIC PHARMA LLC	Prescription	22 Sep 2014
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	solution/drops · ophthalmic	EUGIA PHARMA	Prescription	24 Jul 2018
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	solution/drops · ophthalmic	FDC LTD	Prescription	13 Jun 2019
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	solution/drops · ophthalmic	SOMERSET	Prescription	25 Jun 2019
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	solution/drops · ophthalmic	MICRO LABS	Prescription	28 May 2020
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	solution/drops · ophthalmic	ALEMBIC	Prescription	4 May 2021
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	solution/drops · ophthalmic	EUGIA PHARMA	Prescription	14 May 2021
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	solution/drops · ophthalmic	MICRO LABS	Prescription	25 Jan 2022
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	solution/drops · ophthalmic	GLAND	Prescription	19 Sep 2022
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	solution/drops · ophthalmic	INGENUS PHARMS LLC	Prescription	1 May 2023
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	solution/drops · ophthalmic	ALEMBIC THERAP	Prescription	18 Feb 2025
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	solution/drops · ophthalmic	HIKMA PHARMS	Discontinued	28 Oct 2008
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	solution/drops · ophthalmic	TEVA PHARMS	Discontinued	28 Sep 2009
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	solution/drops · ophthalmic	ZAMBON SPA	Discontinued	4 Dec 2013
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	solution/drops · ophthalmic	CHARTWELL MOLECULAR	Discontinued	17 Dec 2014

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-DORZO-TIMOP	02299615	5 MG / ML; 20 MG / ML	SOLUTION · OPHTHALMIC	APOTEX INC
COSOPT	02240113	5 MG / ML; 20 MG / ML	SOLUTION · OPHTHALMIC	ELVIUM LIFE SCIENCES
COSOPT PRESERVATIVE-FREE	02258692	20 MG / ML; 5 MG / ML	SOLUTION · OPHTHALMIC	ELVIUM LIFE SCIENCES
DORZOLAMIDE-TIMOLOL	02522020	20 MG / ML; 5 MG / ML	SOLUTION · OPHTHALMIC	JAMP PHARMA CORPORATION
DORZOLAMIDE-TIMOLOL	02562138	5 MG / ML; 20 MG / ML	SOLUTION · OPHTHALMIC	STERI-MED PHARMA INC.
M-DORZOLAMIDE-TIMOLOL	02537796	20 MG / ML; 5 MG / ML	SOLUTION · OPHTHALMIC	MANTRA PHARMA INC
MED-DORZOLAMIDE-TIMOLOL	02437686	5 MG / ML; 20 MG / ML	SOLUTION · OPHTHALMIC	GENERIC MEDICAL PARTNERS INC
RIVA-DORZOLAMIDE/TIMOLOL	02441659	5 MG / ML; 20 MG / ML	SOLUTION · OPHTHALMIC	LABORATOIRE RIVA INC.
SANDOZ DORZOLAMIDE/TIMOLOL	02344351	20 MG / ML; 5 MG / ML	SOLUTION · OPHTHALMIC	SANDOZ CANADA INCORPORATED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	COSOPT EYE DROPS	$23.16154	per ML	23 Sep 2026
US NADAC	COSOPT PF EYE DROPS	$3.29952	per EA	23 Sep 2026
US NADAC	DORZOLAMIDE-TIMOLOL 2-0.5%(PF)	$1.09395	per EA	23 Sep 2026
NHS Drug Tariff	Dorzolamide 20mg/ml / Timolol 5mg/ml eye drops	£2.54	5 ml	1 Oct 2026
NHS Drug Tariff	Dorzolamide 20mg/ml / Timolol 5mg/ml eye drops 0.166ml unit dose preservative free	£34.81	60 unit dose	1 Oct 2026
NHS Drug Tariff	Dorzolamide 20mg/ml / Timolol 5mg/ml eye drops 0.2ml unit dose preservative free	£28.59	60 unit dose	1 Oct 2026
NHS Drug Tariff	Dorzolamide 20mg/ml / Timolol 5mg/ml eye drops preservative free	£8.13	5 ml	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Components

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.