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FML

NDA

FLUOROMETHOLONE | N016851 | 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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from ANDA Consultants FDA-2016-P-3696 ANDA Consultants filed this citizen petition on October 12, 2016, requesting that the FDA's Office of Generic Drugs, Division of Bioequivalence develop and publish a product-specific bioequivalence guidance for fluorometholone ophthalmic suspension to facilitate the development of generic equivalent	Other	2016-11-10	Open	ANDA Consultants

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Fml (2023)

Total Spending

$244K

Total Claims

1,286

Beneficiaries

901

Avg Cost/Unit

$28.00

Spending Trend

$247K(2019)→$215K(2020)→$208K(2021)→$247K(2022)→$244K(2023)

YoY Change:-0.6%

5yr CAGR:+0.3%

Source: CMS Medicare Part D Spending by Drug (2023). 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

2 letters from Drugs@FDA

Date	Submission	Document
Feb 13, 2013	SUPPL -63	View Letter (PDF)
Jun 28, 2001	SUPPL -51	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#002 — 0.1%

RLDAB

0 patents0 exclusivities▴

SUSPENSION/DROPS;OPHTHALMIC | Approved: Jul 28, 1982

No patent or exclusivity listings for this strength.