EPIDUO (adapalene)
Epiduo is a topical gel that treats acne vulgaris in patients 9 years of age and older. It combines a retinoid called adapalene with benzoyl peroxide to help patients manage their skin symptoms. This combination therapy is used to address the condition through multiple active components.
How EPIDUO Works
This medication works by binding to specific retinoic acid nuclear receptors to modulate inflammatory processes and how skin cells develop. It also includes benzoyl peroxide, which acts as an oxidizing agent to provide bactericidal and keratolytic effects. Together, these ingredients target the biological mechanisms associated with acne.
Details
- Status
- Prescription
- First Approved
- 2008-12-08
- Patent Cliff
- 2027
- Routes
- TOPICAL
- Dosage Forms
- GEL
EPIDUO Approval History
What EPIDUO Treats
1 indicationsEPIDUO is approved for 1 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acne Vulgaris
EPIDUO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to EPIDUO
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
GALDERMA LABS LP's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01213199 results posted | RD.03.SPR.29088 | Ph 2 | completed | Adapalene Gel 0.3% in the Treatment of Atrophic Acne Scars |
| NCT00660985 results posted | RD.06.SPR.18115 | Ph 4 | completed | Pharmacokinetic Study to Compare the Systemic Exposure of Differin® Gel, 0.3% or Differin® Gel, 0.1% |
| NCT03626298 | PapulexPaper1 | Ph 4 | completed | Efficacy and Tolerability of Nicotinamide Plus Cream for Moderate Acne Vulgaris in Indonesia |
| NCT01406080 FOTEN | BR.10.002 | Ph 3 | completed | A Comparative Study of Adapalene Gel,0.3% Versus Tretinoin Emollient Cream, 0.05% for the Treatment of Photoaging |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
EPIDUO FDA Label Details
Indications & Usage
FDA Label (PDF)EPIDUO is indicated for the treatment of Acne Vulgaris.
Pro Intelligence Preview
Deep insights for EPIDUO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2027
- • 3 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.