TheraRadar
Data updated: Jul 17, 2026

BIMATOPROST · MICRO LABS LTD INDIA

Generic · see DURYSTA
Ophthalmology Approved 2001-03-16

BIMATOPROST is FDA-approved to treat 2 conditions (same as DURYSTA).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
15
Indications
--
Phase 3 Trials
25
Years on Market

Details

Status
Prescription
First Approved
2001-03-16
Routes
OPHTHALMIC, TOPICAL
Dosage Forms
SOLUTION/DROPS, SOLUTION

Companies

MICRO LABS LTD INDIA MANKIND PHARMA Novartis GLAND Apotex Lupin SOMERSET THERAPS LLC GLAND PHARMA LTD Hikma ALEMBIC AMNEAL EUGIA PHARMA MICRO LABS
Active Ingredient: BIMATOPROST

BIMATOPROST Approval History

2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
41 FDA actions from 2014 to 2025
Sep 2025 ORIGINAL
Update
Mar 2025 ORIGINAL
Update
Feb 2024 SUPPL
Label · Labeling

What BIMATOPROST Treats

2 indications

BIMATOPROST is approved for 2 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as DURYSTA (same active ingredient).

Source: FDA Label
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Clinical Trial Registry

13 trials
Trial Sponsor ID Phase Status Title
NCT02390284 STOP-RGCD results posted 20140587 R01EY014957 Ph 3 terminated Stop Retinal Ganglion Cell Dysfunction Study
NCT06122090 00006189 Ph 2 recruiting Treatment of Hypopigmented Scars With Bimatoprost
NCT03825380 results posted LT4032-301 Ph 3 completed Efficacy and Safety Assessment of T4032 Versus Lumigan® in Ocular Hypertensive or Glaucomatous Patients
NCT02358369 results posted FSV5-004 Ph 2 completed Dose-Ranging Study of the Bimatoprost Ocular Insert
NCT02537015 OLE2 results posted FSV5-005 OLE 2 Ph 2 completed An Open-label Extension Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert
NCT02143843 results posted FSV5-003 Ph 2 completed An Open-Label Extension Study to Evaluate the Safety of the ForSight VISION5 Product
NCT02742649 results posted FSV5-FC-001 Ph 1, Ph 2 completed A Study to Evaluate Efficacy and Safety of a Fixed Combination Ocular Insert in Participants With Open-angle Glaucoma or Ocular Hypertension
NCT01915940 results posted FSV5-002 Ph 2 completed Bimatoprost Ocular Insert Compared to Topical Timolol Solution in Patients With Glaucoma or Ocular Hypertension
NCT02676310 192024-085 Ph 1 terminated Safety, Tolerability, and Pharmacokinetics of Bimatoprost in Men With Androgenetic Alopecia (AGA)
NCT02059655 BIMA SPON 1266-14 Ph 4 completed Prostaglandin F2-alpha Eye Drops in Thyroid Eye Disease (Bima Study)
NCT00705757 results posted Pfizer GA6111AX Ph 4 completed The Effects of Xalatan, Travatan and Lumigan on Skin Pigmentation Near the Eye
NCT02170662 results posted Pro00017573 Ph 2 completed Topical Bimatoprost Effect on Androgen Dependent Hair Follicles
NCT01291108 results posted 210669-013 Ph 2 completed Safety and Efficacy of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

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.

BIMATOPROST FDA Label Details

Indications & Usage

FDA Label (PDF)

BIMATOPROST is FDA-approved to treat 2 conditions — same approved indications as DURYSTA.

Looking for the branded version?

DURYSTA

Full clinical data, patents, trials, and competitive landscape for bimatoprost.

See DURYSTA

Data Sources

FDA Approval: ANDA204638 → Trials: ClinicalTrials.gov →

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