Differin

(Adapalene)

Small molecule

GGalderma R&D

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Clinical

Trials by Indication[1]

Acne Vulgaris4 trials

Analysis of Adherence in Subjects Undergoing Differin Gel, 0.1% Treatment of Moderate to Severe Acne Vulgaris

Completed·WWake Forest University·Phase 4·NCT00696449·61 enrolled

Bioequivalence of Adapalene Topical Gel in Patients With Acne Vulgaris

Completed· Teva logo

Teva·Phase 1·NCT01182636·601 enrolled

Role of Vitamin D and Its Topical Analogues in Pathogenesis and Treatment of Acne Vulgaris

Unknown status·—·Phase 4·NCT03866447·80 enrolled

Show 1 more trial

Efficacy and Tolerability of Nicotinamide Plus Cream for Moderate Acne Vulgaris in Indonesia

Completed·RRumah Sakit Pusat Angkatan Darat Gatot Soebroto·Phase 4·NCT03626298·125 enrolled

Treatment2 trials

Adapalene Gel 0.3% in the Treatment of Atrophic Acne Scars

Completed·GGalderma R&D·Phase 2·NCT01213199·20 enrolled

Effect of Samples on Acne Treatment With Epiduo® Gel

Completed·WWake Forest University·Phase 4·NCT01504204·20 enrolled

Efficacy and Safety2 trials

A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris

Completed·GGalderma R&D·Phase 3·NCT00421993·1,670 enrolled

A Study to Evaluate the Efficacy and Safety of Adapalene-Clindamycin Combination Gel in the Treatment of Acne Vulgaris

Completed·LLee's Pharmaceutical Limited·Phase 3·NCT03615768·1,617 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of Tazarotene Cream 0.1% Compared With Adapalene Gel 0.3% in the Treatment of Moderate to Severe Facial Acne Vulgaris

Terminated· AbbVie logo

AbbVie·Phase 4·NCT00829049·165 enrolled

Systemic1 trial

Pharmacokinetic Study to Compare the Systemic Exposure of Differin® Gel, 0.3% or Differin® Gel, 0.1%

Completed·GGalderma R&D·Phase 4·NCT00660985·51 enrolled

4 more indications

Vitamin D1 trial

Vitamin D Supplementation in Acne

Recruiting·HHITEC-Institute of Medical Sciences·N/A·NCT06141330·58 enrolled

Photoaging1 trial

A Comparative Study of Adapalene Gel,0.3% Versus Tretinoin Emollient Cream, 0.05% for the Treatment of Photoaging

Completed·GGalderma Brasil Ltda.·Phase 3·NCT01406080·128 enrolled

RCT1 trial

MC RCT - BPO vs Adapalene

Withdrawn·UUniversity of Oklahoma·Phase 3·NCT05536882

Irritation1 trial

Evaluation of Irritation That Could be Caused by Two Facial Gels Applied to Opposite Sides of the Face.

Completed·BBausch Health Americas, Inc.·Phase 4·NCT00714714·25 enrolled

Regulatory

FDA Approval Timeline[3]

May 31, 1996

DIFFERIN

NDA NDA020338

May 26, 2000

DIFFERIN

NDA NDA020748

Jun 19, 2007

DIFFERIN

NDA NDA021753

Mar 17, 2010

DIFFERIN

NDA NDA022502

Jul 8, 2016

DIFFERIN

NDA NDA020380

Sources

References

[1]
ClinicalTrials.gov — 14 trial records for Adapalene. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Adapalene compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA020380). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Differin. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Galderma R&D company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: GGalderma R&D

Patent Landscape[4]

Patent Cliff

Sep 15, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8435502Sep 15, 2026

8709392Sep 15, 2026

7998467May 31, 2028

Differin

Trials by Indication[1]

Acne Vulgaris4 trials

Treatment2 trials

Efficacy and Safety2 trials

Safety and Efficacy1 trial

Systemic1 trial

Vitamin D1 trial

Photoaging1 trial

RCT1 trial

Irritation1 trial

FDA Approval Timeline[3]

References

Drug Info

Quick Facts

Patent Landscape[4]

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