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Data updated: Mar 10, 2026

TIMOLOL MALEATE

TIMOLOL MALEATE
Cardiovascular Approved 1989-04-13
28
Indications
--
Phase 3 Trials
1
Priority Reviews
36
Years on Market

TIMOLOL MALEATE Approval History

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What TIMOLOL MALEATE Treats

3 indications

TIMOLOL MALEATE is approved for 3 conditions since its original approval in 1989. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypertension
  • Myocardial Infarction
  • Migraine
Source: FDA Label

TIMOLOL MALEATE Competitors

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

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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 TIMOLOL MALEATE

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

PROPRANOLOL HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE
3 shared
IPCA LABS LTD
Shared indications:
HypertensionMyocardial InfarctionMigraine
ALISKIREN HEMIFUMARATE
ALISKIREN HEMIFUMARATE
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PH HEALTH
Shared indications:
HypertensionMyocardial Infarction
ATENOLOL
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AIPING PHARM INC
Shared indications:
HypertensionMyocardial Infarction
ATENOLOL AND CHLORTHALIDONE
ATENOLOL
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WATSON LABS
Shared indications:
HypertensionMyocardial Infarction
AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE
AZILSARTAN KAMEDOXOMIL
2 shared
ALKEM LABS LTD
Shared indications:
HypertensionMyocardial Infarction
AZOR
AMLODIPINE BESYLATE
2 shared
COSETTE
Shared indications:
HypertensionMyocardial Infarction
BYSTOLIC
NEBIVOLOL HYDROCHLORIDE
2 shared
AbbVie
Shared indications:
HypertensionMyocardial Infarction
CADUET
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2 shared
PHARMACIA
Shared indications:
HypertensionMyocardial Infarction
CARVEDILOL PHOSPHATE
CARVEDILOL PHOSPHATE
2 shared
Sun Pharma
Shared indications:
Myocardial InfarctionHypertension
COREG
CARVEDILOL
2 shared
WAYLIS THERAP
Shared indications:
Myocardial InfarctionHypertension
COREG CR
CARVEDILOL PHOSPHATE
2 shared
WAYLIS THERAP
Shared indications:
Myocardial InfarctionHypertension
DIOVAN
VALSARTAN
2 shared
Novartis
Shared indications:
HypertensionMyocardial Infarction
DIOVAN HCT
HYDROCHLOROTHIAZIDE
2 shared
Novartis
Shared indications:
HypertensionMyocardial Infarction
EDARBYCLOR
AZILSARTAN KAMEDOXOMIL
2 shared
AZURITY
Shared indications:
HypertensionMyocardial Infarction
EXFORGE
AMLODIPINE BESYLATE
2 shared
Novartis
Shared indications:
HypertensionMyocardial Infarction
EXFORGE HCT
AMLODIPINE BESYLATE
2 shared
Novartis
Shared indications:
HypertensionMyocardial Infarction
INDERAL LA
PROPRANOLOL HYDROCHLORIDE
2 shared
ANI PHARMS
Shared indications:
HypertensionMigraine
INNOPRAN XL
PROPRANOLOL HYDROCHLORIDE
2 shared
ANI PHARMS
Shared indications:
HypertensionMyocardial Infarction
JAVADIN
CLONIDINE HYDROCHLORIDE
2 shared
AZURITY
Shared indications:
HypertensionMyocardial Infarction
LISINOPRIL
LISINOPRIL
2 shared
Aurobindo Pharma
Shared indications:
HypertensionMyocardial Infarction
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Active Pipeline

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Ongoing clinical trials by development phase

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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

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.

TIMOLOL MALEATE FDA Label Details

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Indications & Usage

FDA Label (PDF)

Hypertension Timolol maleate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. Myocardial Infarction Timolol is indicated in patients who have survived the acute phase of myocardial infarction, and are clinically stable, to reduce cardiovascular mortality and the risk of reinfarction. Migraine Timolol is indicated for the prophylaxis of migraine headache.

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Data Sources

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