NDATOPICALGEL
Approved
Dec 2008
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
12
Data completeness
5/8 — Partial
EPIDUO (adapalene and benzoyl peroxide) by Galderma is protein. First approved in 2008.
Drug data last refreshed 10m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EPIDUO is a topical gel combining adapalene (a retinoid modulator of cellular differentiation and keratinization) and benzoyl peroxide (an oxidizing antibacterial agent) approved for acne treatment. The combination addresses inflammatory processes and bacterial colonization simultaneously through complementary mechanisms. It represents a fixed-dose combination strategy in dermatology.
LOE Approaching1.1 years to LOE
Product faces loss of exclusivity in July 2027 (1.1 years remaining); commercial teams should prioritize lifecycle extension strategies and brand loyalty initiatives before generic erosion.
Mechanism of Action
protein. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization and inflammatory processes. However, the significance of these findings with regard to the mechanism of action of adapalene for the treatment of acne…
Pharmacologic Class:
Retinoid
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (12)
Study to Compare the Safety and Efficacy of IDP-126 Gel to Epiduo® Forte Gel and Vehicle Gel
Started Jun 2021
686 enrolled
Acne Vulgaris
Application of Epiduo(R) PUMP in Daily Practice in Patients With Inflammatory Acne
Started Jan 2015
1,388 enrolled
Acne Vulgaris
Long-term Study of Epiduo in Patients With Moderate to Severe Acne
Started Jun 2012
6,036 enrolled
Acne Vulgaris
Effect of Samples on Acne Treatment With Epiduo® Gel
Started Dec 2011
20 enrolled
Acne Vulgaris
Efficacy & Safety Comparison of Epiduo With Doxycycline Versus Vehicle With Isotretinoin in the Treatment of Severe Acne
Started Nov 2011
266 enrolled
Acne
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.