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LUMIGAN

NDA

BIMATOPROST | N021275 | ABBVIE INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Pfizer Inc. - Citizen Petition FDA-2006-P-0072 · 9 docket documents Pfizer Inc. filed this citizen petition under 21 C.F.R. 10.30 requesting that the FDA revoke Allergan Inc.'s supplemental NDA #21-275/5-013 approval for Lumigan (bimatoprost ophthalmic solution 0.03%) for a first-line indication and deny Alcon Inc.'s supplemental NDA #21-257 for Travatan (travoprost	505(q)	2008-09-29	Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

117 trials from ClinicalTrials.gov — 1 recruiting, 1 active, 103 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Long-term Safety and Efficacy Extension Trial of Bimatoprost SR NCT03891446	Phase 3	Active	AbbVie	455	2019-03-27 → 2026-08
Bimatoprost as a Treatment for Graves' Orbitopathy NCT03708627	Early Phase 1	Recruiting	Johns Hopkins University	3	2017-11-01 → 2031-07-01
Safety and Efficacy Study of Bimatoprost in the Treatment of Women With Female Pattern Hair Loss NCT01325350	Phase 2	Completed	Allergan	306	2011-06 → 2012-09
Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension NCT01157364	Phase 1/2	Completed	Allergan	109	2010-09-23 → 2016-08-09
Safety and Efficacy of Bimatoprost Timolol Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension NCT01068964	N/A	Completed	Allergan	235	2010-02-01 → 2010-09-01
24-hour Intraocular Pressure (IOP) Control With the Bimatoprost/Timolol Fixed Combination NCT00486486	Phase 4	Completed	Aristotle University Of Thessaloniki	60	2007-03 → 2008-07
Safety and Efficacy of Adding AZARGA® Adjunctive to Prostaglandin Therapy NCT01263444	Phase 4	Completed	Alcon Research	47	2011-03 → 2013-04
24-hour IOP-lowering Effect of 0.01% Bimatoprost NCT01271686	Phase 4	Completed	University of California, San Diego	16	2011-01 → 2012-10
Safety and Efficacy Study of Bimatoprost in Patients With Glaucoma or Ocular Hypertension NCT00300443	Phase 2/3	Completed	Allergan	561	2005-12 → 2007-06
Treatment of Soft Tissue Expansion in Inactive Thyroid Eye Disease Patients Using Drops of Prostaglandin Analogues NCT02155049	Phase 3	Completed	Rabin Medical Center	10	2014-11 → 2017-05

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Lumigan (2024)

Total Spending

$647.2M

Total Claims

1,407,999

Beneficiaries

336,870

Avg Cost/Unit

$96.72

Spending Trend

$594.4M(2019)→$633.5M(2020)→$668.7M(2021)→$701.3M(2022)→$697.0M(2023)→$647.2M(2024)

YoY Change:-3.0%

5yr CAGR:+3.8%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain14 active DMFs1 inactive

14 active API suppliers hold Drug Master Files for this ingredient.

JOHNSON MATTHEY PHARMA SERVICESBIMATOPROST (3077.E)

DMF 209112007

CHIROGATE INTERNATIONAL INCBIMATOPROST

DMF 213822008

KYOWA PHARMA CHEMICAL CO LTDBIMATOPROST DRUG SUBSTANCE

DMF 216812008

EVERLIGHT CHEMICAL INDUSTRIAL CORPBIMATOPROST

DMF 220802008

INDUSTRIALE CHIMICA SRLBIMATOPROST

DMF 234802010

CAYMAN PHARMA SROBIMATOPROST

DMF 243532011

YS LIFE SCIENCE CO LTDBIMATOPROST

DMF 249062011

C-SQUARED PHARMA LTDBIMATOPROST

DMF 259032012

MSN LABORATORIES PRIVATE LTDBIMATOPROST [ROUTE CODE - "BM"]

DMF 270442013

SCINOPHARM TAIWAN LTDBIMATOPROST

DMF 272172013

EUROAPI HUNGARY LTDBIMATOPROST

DMF 295602015

FDC LTDBIMATOPROST USP

DMF 403502024

NEWCHEM SPABIMATOPROST

DMF 418902025

ZHEJIANG AUSUN PHARMACEUTICAL CO LTDBIMATOPROST

DMF 434762026

LUPIN LTDInactiveBIMATOPROST

DMF 268772013

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Mar 9, 2022	SUPPL -29	View Letter (PDF)
Oct 16, 2020	SUPPL -28	View Letter (PDF)
Aug 2, 2017	SUPPL -27	View Letter (PDF)
Oct 2, 2014	SUPPL -26	View Letter (PDF)
Mar 19, 2012	SUPPL -23	View Letter (PDF)
Jun 28, 2006	SUPPL -13	View Letter (PDF)
Jun 8, 2004	ORIG -1	View Letter (PDF)
Nov 25, 2003	SUPPL -14	View Letter (PDF)
Nov 25, 2003	SUPPL -15	View Letter (PDF)
Aug 28, 2003	SUPPL -12	View Letter (PDF)
Aug 28, 2003	SUPPL -10	View Letter (PDF)
Aug 26, 2002	SUPPL -6	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.03% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Mar 16, 2001

No patent or exclusivity listings for this strength.