Viewing data from:

FLAREX

NDA

FLUOROMETHOLONE ACETATE | N019079 | HARROW EYE LLC

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

13 trials from ClinicalTrials.gov, 9 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Usefulness of Topical Non-Steroidal Anti-Inflammatory Drugs or Steroids Before Trabeculectomy and Clinical Outcomes NCT00707421	Phase 3	Completed	Universitaire Ziekenhuizen KU Leuven	62	2005-07 → 2009-05
FLuorometholone as Adjunctive MEdical Therapy for TT Surgery (FLAME) Trial NCT04149210	Phase 3	Completed	Massachusetts Eye and Ear Infirmary	2,410	2021-08-19 → 2024-11-30
Efficacy of Nonsteroidal Anti-inflammatory Drugs in Treatment of Moderate and Severe Dry Eye Disease NCT01562795	N/A	Completed	Wenzhou Medical University	48	2012-03 → 2012-07
Comparison of Two Steroid Regimens to Prevent Transplant Rejection After Corneal Transplant (DMEK)NCT01448213	Phase 2	Completed	Price Vision Group	264	2011-10 → 2014-01
Fluorometholone as Ancillary Therapy for TT Surgery NCT01949454	N/A	Completed	University of Pennsylvania	154	2013-11 → 2016-04
Efficacy and Safety of Fluorometholone (FML) in Dry Eye Disease (Keratoconjunctivitis Sicca)NCT02051023	Phase 3	Completed	Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA	41	2014-02 → 2014-12
Randomized Controlled Trial of Subconjunctival Bevacizumab Injection in Impending Recurrent Pterygium NCT01288404	N/A	Completed	Ramathibodi Hospital	80	2008-01 → 2010-11
Ocular-hypertensive Response to Topical Steroids in Children After Bilateral Strabismus Surgery NCT02816905	Phase 4	Completed	Cairo University	40	2015-10 → 2016-06
Treatment of Corneal Infiltrates Secondary to Epidemic Keratoconjunctivitis NCT04376970	Phase 4	Completed	Military Hospital of Tunis	51	2017-04-01 → 2019-04-01
Safety and Efficacy of Lotemax Versus FML in Subjects Undergoing PRK for the Correction of Mild to Moderate Myopia, 3- Month Follow-up Study NCT02974387	Phase 4	UNKNOWN	Dr Salouti Eye Research Center	200	2017-04 → 2017-11

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$23.94

per ml

Lowest NADAC/Unit

$23.94

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
71776010005FLAREX 0.1% EYE DROPS	$23.94	ML	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$93.15

Highest Price

$93.15

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
82667-0010-00FLAREX 0.1% SUSP,OPH	$93.15	FSS	Harrow Eye, LLC	03/14/2029
71776-0100-05FLAREX 0.1% SUSP,OPH	$93.15	FSS	Harrow Eye, LLC	03/14/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Flarex (2024)

Total Spending

$2.6M

Total Claims

19,312

Beneficiaries

10,380

Avg Cost/Unit

$24.71

Spending Trend

$761K(2019)→$1.2M(2020)→$2.2M(2021)→$3.6M(2022)→$4.0M(2023)→$2.6M(2024)

YoY Change:-6.8%

5yr CAGR:+6.1%

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Sep 25, 2025	SUPPL -41	View Letter (PDF)
May 28, 2024	SUPPL -38	View Letter (PDF)
Aug 3, 2022	SUPPL -33	View Letter (PDF)
Mar 6, 2017	SUPPL -30	View Letter (PDF)
Nov 14, 2006	SUPPL -24	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.1%

RLD

0 patents0 exclusivities▴

SUSPENSION/DROPS;OPHTHALMIC | Approved: Feb 11, 1986

No patent or exclusivity listings for this strength.