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Data updated: Mar 10, 2026

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

DORZOLAMIDE HYDROCHLORIDE
Cardiovascular Approved 2008-10-28
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
19
Indications
--
Phase 3 Trials
17
Years on Market

Details

Status
Prescription
First Approved
2008-10-28
Routes
OPHTHALMIC
Dosage Forms
SOLUTION/DROPS

Companies

BAUSCH AND LOMB SOMERSET EUGIA PHARMA RUBICON RESEARCH CHARTWELL MOLECULAR MICRO LABS NEW HEIGHTSRX INGENUS PHARMS LLC Novartis ZAMBON SPA Teva FDC LTD ALEMBIC GLAND Hikma REGCON HOLDINGS EPIC PHARMA LLC
Active Ingredient: DORZOLAMIDE HYDROCHLORIDE , TIMOLOL MALEATE

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE Approval History

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What DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE Treats

2 indications

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE is approved for 2 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Glaucoma
  • Ocular Hypertension
Source: FDA Label

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE Competitors

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10 other drugs also target Beta-1 adrenergic receptor. Compare mechanisms, indications, and trial activity.

METOPROLOL TARTRATE
Sun Pharma
TIMOLOL MALEATE
CHARTWELL RX
ESMOLOL HYDROCHLORIDE
Hikma
TIMOPTIC
BAUSCH AND LOMB INC
COSOPT PF
THEA PHARMA
BREVIBLOC
Baxter
BREVIBLOC IN PLASTIC CONTAINER
Baxter
BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER
Baxter
View all 10 Beta-1 adrenergic receptor drugs →
Drug = Competitor name Company = Manufacturer N indic. = FDA-approved indications → Date = Patent/exclusivity expiry

Competitors share the same molecular target (Beta-1 adrenergic receptor). Earlier expiry dates signal biosimilar/generic opportunities.

Drugs Similar to DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ALPHAGAN P
BRIMONIDINE TARTRATE
2 shared
AbbVie
Shared indications:
GlaucomaOcular Hypertension
BETAGAN
LEVOBUNOLOL HYDROCHLORIDE
2 shared
AbbVie
Shared indications:
GlaucomaOcular Hypertension
BETOPTIC
BETAXOLOL HYDROCHLORIDE
2 shared
Novartis
Shared indications:
GlaucomaOcular Hypertension
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
BRIMONIDINE TARTRATE
2 shared
UPSHER SMITH LABS
Shared indications:
GlaucomaOcular Hypertension
COMBIGAN
BRIMONIDINE TARTRATE
2 shared
AbbVie
Shared indications:
GlaucomaOcular Hypertension
COSOPT
DORZOLAMIDE HYDROCHLORIDE
2 shared
THEA PHARMA
Shared indications:
GlaucomaOcular Hypertension
COSOPT PF
DORZOLAMIDE HYDROCHLORIDE
2 shared
THEA PHARMA
Shared indications:
GlaucomaOcular Hypertension
DURYSTA
BIMATOPROST
2 shared
AbbVie
Shared indications:
GlaucomaOcular Hypertension
IYUZEH
LATANOPROST
2 shared
THEA PHARMA
Shared indications:
GlaucomaOcular Hypertension
SIMBRINZA
BRIMONIDINE TARTRATE
2 shared
Novartis
Shared indications:
GlaucomaOcular Hypertension
TIMOLOL
TIMOLOL
2 shared
SOMERSET
Shared indications:
GlaucomaOcular Hypertension
TRAVATAN Z
TRAVOPROST
2 shared
Novartis
Shared indications:
GlaucomaOcular Hypertension
XALATAN
LATANOPROST
2 shared
UPJOHN
Shared indications:
GlaucomaOcular Hypertension
ACETAZOLAMIDE
ACETAZOLAMIDE
1 shared
MANKIND PHARMA
Shared indications:
Glaucoma
AZOPT
BRINZOLAMIDE
1 shared
Novartis
Shared indications:
Ocular Hypertension
BETOPTIC S
BETAXOLOL HYDROCHLORIDE
1 shared
Novartis
Shared indications:
Ocular Hypertension
BRINZOLAMIDE
BRINZOLAMIDE
1 shared
BAUSCH AND LOMB
Shared indications:
Ocular Hypertension
IDOSE TR
TRAVOPROST
1 shared
GLAUKOS
Shared indications:
Ocular Hypertension
ISTALOL
TIMOLOL MALEATE
1 shared
BAUSCH AND LOMB
Shared indications:
Ocular Hypertension
LATANOPROSTENE BUNOD
LATANOPROSTENE BUNOD
1 shared
GLAND
Shared indications:
Ocular Hypertension
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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE FDA Label Details

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Indications & Usage

FDA Label (PDF)

Dorzolamide hydrochloride and timolol maleate ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [...

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Data Sources

FDA Approval: ANDA090037 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.