Viewing data from:

DUREZOL

NDA

DIFLUPREDNATE | N022212 | SANDOZ 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
Citizen Petition from Alcon Pharmaceuticals, Ltd. Novartis Pharmaceuticals Co... FDA-2016-P-2781 · 6 docket documents Alcon Pharmaceuticals, Ltd. and Novartis Pharmaceuticals Corporation filed this citizen petition under section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA require any ANDA applicant citing Durezol (difluprednate ophthalmic emulsion, 0.05%) as the reference listed drug	505(q)	2016-09-19	Partially Denied	Alcon Pharmaceuticals, Ltd. Novartis Pharmaceuticals Corporation

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

Clinical Trials

18 trials from ClinicalTrials.gov, 17 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Clinical Study of the Efficacy of the Ophthalmic Emulsion PRO-145 for Inflammation and Pain After Phacoemulsification NCT03693989	Phase 3	Completed	Laboratorios Sophia S.A de C.V.	178	2018-10-04 → 2019-10-22
Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis NCT00405496	Phase 2	Completed	Sirion Therapeutics, Inc.	24	2000-03 → 2001-04
Safety and Efficacy of Difluprednate 0.05% for the Treatment of Anterior Uveitis NCT01201798	Phase 3	Completed	Alcon Research	111	2010-10 → 2011-08
Evaluation of Anti-Inflammatory Treatment in Dry Eye Patients NCT01276223	Phase 2	Completed	Alcon Research	722	2011-02 → 2012-01
Study of Difluprednate in the Treatment of Uveitis NCT00501579	Phase 3	Completed	Sirion Therapeutics, Inc.	—	—
Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601-004)NCT00616993	Phase 3	Completed	Sirion Therapeutics, Inc.	120	2008-01 → 2008-03
Study of Difluprednate vs. Prednisolone Acetate on Visual Acuity, and Corneal Edema Following Cataract Surgery.NCT01244334	Phase 4	Completed	Edward J. Holland	52	2009-03 → 2010-11
Difluprednate Pediatric Study for the Treatment of Inflammation Post-Cataract Surgery NCT01124045	Phase 3	Completed	Alcon Research	80	2010-08 → 2012-04
Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601A-002b)NCT00430092	Phase 3	Completed	Sirion Therapeutics, Inc.	219	—
Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis NCT00406887	Phase 3	Completed	Sirion Therapeutics, Inc.	140	2002-08 → 2003-11

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs (1 brand, 1 generic)

Highest NADAC/Unit

$42.32

per ml

Lowest NADAC/Unit

$7.05

per ml

Brand NDCs

Generic NDCs

Avg Brand: $42.32

Avg Generic: $7.05

83% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
66758008675DUREZOL 0.05% EYE DROPS	$42.32	ML	Brand	$7.05	2026-06-17
00781600078DIFLUPREDNATE 0.05% EYE DROP	$7.05	ML	Generic	—	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

$45.50

Highest Price

$166.15

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00781-6000-78DIFLUPREDNATE 0.05% EMULSION,OPH	$45.50	FSS	Sandoz, Inc.	08/14/2028
66758-0086-75DUREZOL 0.05% EMULSION,OPH	$166.15	FSS	Sandoz, Inc.	08/14/2028

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

Medicare Part D Spending

CMS annual spending data for Durezol (2024)

Total Spending

$805K

Total Claims

2,990

Beneficiaries

1,541

Avg Cost/Unit

$42.00

Spending Trend

$107.5M(2019)→$67.9M(2020)→$49.8M(2021)→$14.7M(2022)→$629K(2023)→$805K(2024)

YoY Change:-7.0%

5yr CAGR:-7.0%

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

API Supply Chain4 active DMFs

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

TAPI NL BVDIFLUPREDNATE

DMF 198702006

FARMABIOS SPADIFLUPREDNATE (MICRONIZED)

DMF 252282011

CHEMWERTH INCDIFLUPREDNATE

DMF 263782013

STEROID SPADIFLUPREDNATE

DMF 327782018

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Oct 28, 2025	SUPPL -25	View Letter (PDF)
Jul 16, 2025	SUPPL -18	View Letter (PDF)
Aug 2, 2016	SUPPL -16	View Letter (PDF)
May 16, 2013	SUPPL -12	View Letter (PDF)
Mar 26, 2013	SUPPL -11	View Letter (PDF)
Nov 28, 2012	SUPPL -10	View Letter (PDF)
Jun 15, 2012	SUPPL -3	View Letter (PDF)
Mar 25, 2009	SUPPL -1	View Letter (PDF)
Jun 24, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.05%

RLDAB

0 patents0 exclusivities▴

EMULSION;OPHTHALMIC | Approved: Jun 23, 2008

No patent or exclusivity listings for this strength.