TheraRadar

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Data updated: Mar 10, 2026

ZOLYMBUS

BIMATOPROST
Cardiovascular Approved 2025-09-09
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
0
Years on Market

Details

Status
Prescription
First Approved
2025-09-09
Routes
OPHTHALMIC
Dosage Forms
GEL

Companies

THEA PHARMA
Active Ingredient: BIMATOPROST

ZOLYMBUS Approval History

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What ZOLYMBUS Treats

2 indications

ZOLYMBUS is approved for 2 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Open-Angle Glaucoma
  • Ocular Hypertension
Source: FDA Label

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Key Completed Trials

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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.

ZOLYMBUS FDA Label Details

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Indications & Usage

FDA Label (PDF)

ZOLYMBUS™ is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. ZOLYMBUS™ is a prostaglandin analog indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

ZOLYMBUS Patents & Exclusivity

Latest Patent: Jun 2036
Exclusivity: Sep 2028

Patents (1 active)

US10314780 Expires Jun 8, 2036

Exclusivity

NDF Until Sep 2028
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA217307 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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