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DIFFERIN EPIDUO

NDA

ADAPALENE; BENZOYL PEROXIDE | N220736 | GALDERMA LABORATORIES LP

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

31 trials from ClinicalTrials.gov, 28 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy and Safety Study of GK530G Versus CD0271 0.1% Gel and CD1579 2.5% Gel in the Treatment of Acne Vulgaris.NCT02073448	Phase 3	Completed	Galderma R&D	417	2014-03 → 2014-10
Evaluation of Irritation by Two Facial Gels Applied to Opposite Sides of the Face NCT00919191	Phase 4	Completed	Bausch Health Americas, Inc.	26	2009-04 → 2009-05
Assessment of Subjects' Efficacy and Experiences Using Adapalene BPO Gel in the Treatment of Acne Vulgaris NCT01209949	Phase 4	Completed	Galderma R&D	30	2010-10 → 2011-01
Study Comparing Adapalene/BP Gel to EPIDUO® FORTE and Both to a Placebo Control in Treatment of Acne Vulgaris NCT02709902	Phase 1	Completed	Sun Pharmaceutical Industries, Inc.	460	2015-09 → 2016-03
Pirfenidone Plus M-DDO Gel in Moderate and Severe Acne NCT03076320	Phase 1/2	Completed	University of Guadalajara	82	2017-03-27 → 2019-03-31
A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Facial Acne NCT00964223	Phase 4	Completed	Stiefel, a GSK Company	28	2009-07 → 2009-11
Long-term Study of Efficacy/Safety of Adapalene/Benzoyl Peroxide Topical Gel in Acne Vulgaris Subjects NCT00446043	Phase 3	Completed	Galderma R&D	452	2004-02-17 → 2005-05-23
Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris NCT00422240	Phase 3	Completed	Galderma R&D	1,668	2006-06-27 → 2007-07-12
A Treatment Regimen for Student Athletes With Mild to Moderate Acne Vulgaris NCT02249104	Phase 4	Completed	Galderma R&D	28	2014-08 → 2015-02
Bioequivalence Study of Two Treatments in the Treatment of Acne Vulgaris on the Face NCT03393494	Phase 3	Completed	Padagis LLC	825	2017-12-13 → 2019-01-05

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 22, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.1%;2.5%

RLD

0 patents0 exclusivities▴

GEL;TOPICAL | Approved: May 22, 2026

No patent or exclusivity listings for this strength.