TheraRadar
Data updated: Jun 17, 2026

DIFFERIN (adapalene)

Dermatology Approved 1996-05-31

Use For the treatment of acne

Source: FDA Label • GALDERMA LABS LP
Jump to: Indications Approvals Trials Competitors Safety Patents
5
Indications
--
Phase 3 Trials
30
Years on Market

Details

Status
Discontinued
First Approved
1996-05-31
Patent Cliff
2028

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Patent cliff and revenue data

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Routes
TOPICAL
Dosage Forms
SOLUTION, CREAM, GEL, LOTION

Companies

GALDERMA LABS LP
Active Ingredient: ADAPALENE

DIFFERIN Approval History

1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
27 FDA actions from 1996 to 2023 · 1 indication expansions
Dec 2023 SUPPL
Label · Labeling
FDA Letter Label
Apr 2023 SUPPL
Label · Labeling
FDA Letter Label
Aug 2022 SUPPL
Label · Labeling
FDA Letter Label

What DIFFERIN Treats

5 FDA approvals

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

  • Other (5)

GALDERMA LABS LP's other novel FDA approvals

Other CDER-designated drugs from the same sponsor (2016–2025).

NEMLUVIO
2024
NEMOLIZUMAB-ILTO
3 designations
AKLIEF
2019
TRIFAROTENE
📋

Clinical Trial Registry

5 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
NCT01387048 SKADI BS-HAU-2011 2011-000152-42 Ph 4 completed Study for Long-term Treatment of Acne Vulgaris With Skinoren Versus Differin
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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

ClinicalTrials.gov ↗ Pro

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

Indications & Usage

FDA Label (PDF)

Use For the treatment of acne

View full patent landscape →
3 OB patents · 1 families · 16 international docs across 6 countries

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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Deep insights for DIFFERIN

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2028
  • • 3 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA020338 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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