Viewing data from:

EPIDUO FORTE

NDA

ADAPALENE; BENZOYL PEROXIDE | N207917 | GALDERMA LABORATORIES 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

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.

Drug Pricing (NADAC)

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

Highest NADAC/Unit

$14.97

per gm

Lowest NADAC/Unit

$0.7063

per gm

Brand NDCs

Generic NDCs

Avg Brand: $14.97

Avg Generic: $0.7063

95% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00299590645EPIDUO FORTE 0.3-2.5% GEL PUMP	$14.97	GM	Brand	$0.7063	2026-06-17
68308066245ADAPALENE-BNZYL PEROX 0.3-2.5%	$0.7063	GM	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 | 3 NDCs (2 FSS, 1 Big4)

Lowest Price

$11.06

Highest Price

$125.41

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
68308-0662-45ADAPALENE 0.3%/BENZOYL PEROXIDE 2.5% GEL,TOP	$11.06	FSS	Mayne Pharma Commercial LLC	07/14/2030
00299-5906-45EPIDUO FORTE	$125.41	FSS	Galderma Laboratories LP	03/31/2026
00299-5906-45EPIDUO FORTE	$125.41	Big4	Galderma Laboratories LP	03/31/2026

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

Medicare Part D Spending

CMS annual spending data for Epiduo Forte (2024)

Total Spending

$61K

Total Claims

Beneficiaries

Avg Cost/Unit

$14.97

Spending Trend

$440K(2019)→$470K(2020)→$473K(2021)→$150K(2022)→$77K(2023)→$61K(2024)

YoY Change:+12.1%

5yr CAGR:+5.4%

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Apr 29, 2022	SUPPL -8	View Letter (PDF)
Apr 29, 2022	SUPPL -4	View Letter (PDF)
Jul 20, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.3%;2.5%

RLDAB

0 patents0 exclusivities▴

GEL;TOPICAL | Approved: Jul 15, 2015

No patent or exclusivity listings for this strength.