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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 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

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 Durezol (2023)

Total Spending

$972K

Total Claims

3,661

Beneficiaries

2,284

Avg Cost/Unit

$45.31

Spending Trend

$107.5M(2019)→$67.9M(2020)→$49.8M(2021)→$14.7M(2022)→$972K(2023)

YoY Change:+4.4%

5yr CAGR:+4.4%

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