TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

DIFFERIN

ADAPALENE
Dermatology Approved 1996-05-31
5
Indications
--
Phase 3 Trials
29
Years on Market

Details

Status
Prescription
First Approved
1996-05-31
Routes
TOPICAL
Dosage Forms
GEL, LOTION, CREAM, SOLUTION

Companies

Active Ingredient: ADAPALENE

DIFFERIN Approval History

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What DIFFERIN Treats

5 FDA approvals

Originally approved for its first indication in 1996 . Covers 5 distinct patient populations.

  • Other (5)
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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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.

DIFFERIN FDA Label Details

Pro

Indications & Usage

FDA Label (PDF)

Use For the treatment of acne

DIFFERIN Patents & Exclusivity

Latest Patent: May 2028

Patents (3 active)

US7998467 Expires May 31, 2028
US8435502 Expires Sep 15, 2026
US8709392 Expires Sep 15, 2026
Source: FDA Orange Book

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.