TheraRadar
Data updated: May 26, 2026

LUMIGAN (bimatoprost)

Trial Activity: Declining
Ophthalmology Approved 2001-03-16
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Laboratoires Thea conducting 1 trials (33%)
4 indications explored (Focused)
→ ocular hypertension (3 trials)
→ glaucoma (1 trials)
→ open-angle glaucoma (1 trials)
3
Indications
--
Phase 3 Trials
1
Priority Reviews
25
Years on Market

Details

Status
Discontinued
First Approved
2001-03-16
Patent Cliff
2027

Pro Metrics

Patent cliff and revenue data

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Routes
OPHTHALMIC
Dosage Forms
SOLUTION/DROPS

Companies

AbbVie
Active Ingredient: BIMATOPROST

LUMIGAN Approval History

2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
26 FDA actions from 2001 to 2022 · 1 indication expansions
Mar 2022 SUPPL
Label · Labeling
FDA Letter Label
Oct 2020 SUPPL
Label · Labeling
FDA Letter Label
Sep 2020 SUPPL
Label · Labeling
FDA Letter Label

What LUMIGAN Treats

3 FDA approvals

Originally approved for its first indication in 2001 . Covers 3 distinct patient populations.

  • Other (3)
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Clinical Trial Registry

15 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
NCT04285580 results posted 1698-304-007 Ph 3 completed A Phase 3b Study Evaluating the 24-Hour Intraocular Pressure Lowering Effect of Bimatoprost SR in Patients With Open-Angle Glaucoma or Ocular Hypertension
NCT03927443 CLR_17_21 Ph 3 withdrawn A Comparative Study of SPARC's SDP-133 Once Daily and Lumigan in Subjects With Open Angle Glaucoma or Ocular Hypertension
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

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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

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.

LUMIGAN FDA Label Details

View full patent landscape →
1 OB patents · 1 families · 63 international docs across 23 countries

LUMIGAN Patents & Exclusivity

Latest Patent: Jun 2027

Patents (1 active)

US7851504 Expires Jun 13, 2027
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for LUMIGAN

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2027
  • • 1 active patents

Trial Analysis

  • • 3 total trials
  • • Stage: Declining

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA021275 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment