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FML FORTE

NDA

FLUOROMETHOLONE | N019216 | 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

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 | 2 NDCs

Highest NADAC/Unit

$32.15

per ml

Lowest NADAC/Unit

$32.13

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
11980022805FML FORTE 0.25% EYE DROPS	$32.15	ML	Brand	—	2026-06-17
11980022810FML FORTE 0.25% EYE DROPS	$32.13	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 | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$126.07

Highest Price

$331.77

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
11980-0228-10FML FORTE OPHTH SUSP #000228	$331.77	FSS	Abbvie US LLC	07/31/2030
11980-0228-10FML FORTE OPHTH SUSP #000228	$252.14	Big4	Abbvie US LLC	07/31/2030
11980-0228-05FML FORTE OPHTH SUSP #000227	$165.88	FSS	Abbvie US LLC	07/31/2030
11980-0228-05FML FORTE OPHTH SUSP #000227	$126.07	Big4	Abbvie US LLC	07/31/2030

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

Medicare Part D Spending

CMS annual spending data for Fml Forte (2024)

Total Spending

$898K

Total Claims

3,778

Beneficiaries

2,350

Avg Cost/Unit

$33.58

Spending Trend

$1.7M(2019)→$1.6M(2020)→$1.4M(2021)→$797K(2022)→$887K(2023)→$898K(2024)

YoY Change:-4.2%

5yr CAGR:+0.7%

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

API Supply Chain4 active DMFs3 inactive

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

EUROAPI FRANCEFLUOROMETHOLONE

DMF 44231982

FARMABIOS SPAFLUOROMETHOLONE

DMF 357802021

CURIA SPAIN SAUFLUOROMETHOLONE MICRONIZED

DMF 367722022

HENAN LIHUA PHARMACEUTICAL CO LTDFLUOROMETHOLONE

DMF 376742023

PHARMACIA AND UPJOHNInactiveFLUOROMETHOLONE MICRONIZED

DMF 15411970

ANTIBIOTICOS SPAInactiveFLUOROMETHOLONE 17-ACETATE NON-MICRONIZED AND MICRONIZED

DMF 37861980

SICOR SPAInactiveFLUOROMETHOLONE

DMF 47611982

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Feb 14, 2025	SUPPL -30	View Letter (PDF)
Feb 13, 2013	SUPPL -25	View Letter (PDF)
Jan 20, 2006	SUPPL -21	View Letter (PDF)
Jan 20, 2006	SUPPL -22	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.25%

RLD

0 patents0 exclusivities▴

SUSPENSION/DROPS;OPHTHALMIC | Approved: Apr 23, 1986

No patent or exclusivity listings for this strength.