Difluprednate

Treats inflammation and pain associated with ocular surgery. Sold as Durezol. Every FDA application for this active ingredient: 1 branded and 8 generic.

As of Nov 15, 2026, FDA lists 9 applications for Difluprednate (sold as Durezol), first approved Jun 23, 2008, with 2 new uses approved and 0 published complete response letters.

First approved: Jun 23, 2008
Applications: 9
New uses approved: 2
Complete response letters: 0
Medicare spending, 2025: $15.1M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Difluprednate	Part D	$14.7M	+3%	64,892
Durezol	Part D	$423K	-47%	667

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

DIFLUPREDNATE 0.05% EYE DROP: $9.07 per MLGeneric · -9% in a year
DUREZOL 0.05% EYE DROPS: $42.25 per MLBrand · -1% in a year

Orphan Designations (FDA)

One designation, 1 approved for the designated use; see all orphan designations

Treatment of endogenous and traumatic anterior uveitis and panuveitis.Alcon Pharmaceuticals. Ltd. · designated Sep 30, 2008 · approved Jun 13, 2012

Clinical Trials

2 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


A Study to Evaluate KRIYA-825 (VV-14295) in Adults With Geographic Atrophy Secondary to Age-related Macular DegenerationGeographic Atrophy Secondary to Age-related Macular Degeneration · Kriya Therapeutics, Inc.	Phase 1 / Phase 2	Recruiting	Jan 9, 2025
Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction IIBacterial Keratitis · University of California, San Francisco	Phase 3	Active, not recruiting	Feb 22, 2024

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jun 23, 2008	DurezolNDA 22212 · New molecular entity	Sandoz	10	Marketed
Aug 9, 2021	DifluprednateANDA 211776	Cipla	0	Discontinued
Nov 17, 2021	DifluprednateANDA 211526	Amneal	0	Marketed
Nov 16, 2022	DifluprednateANDA 214894	Dr Reddys	0	Marketed
May 14, 2024	DifluprednateANDA 207284	Epic Pharma LLC	0	Marketed
Dec 13, 2024	DifluprednateANDA 219441	Caplin	0	Marketed
Feb 11, 2025	DifluprednateANDA 218191	Upsher Smith Labs	0	Marketed
Mar 20, 2025	DifluprednateANDA 212566	Mylan Labs Ltd	0	Marketed
Jan 26, 2026	DifluprednateANDA 213774	Alembic	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA