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DIFFERIN

NDA

ADAPALENE | N020380 | GALDERMA LABORATORIES LP

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Call Inc. dba Rochester Pharmaceuticals (Ei Inc.) - Citizen Petition FDA-2012-P-0916 · 5 docket documents Ei Inc. on behalf of Call Inc. dba Rochester Pharmaceuticals submitted this citizen petition under 21 CFR §10.20, §10.30, and §314.122, and Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act, requesting that the FDA determine whether the reference listed drug Differin (adapalene soluti	Other	2012-09-07	Granted	—
Galderma Laboratories L. P. - Citizen Petition FDA-2009-P-0265 · 3 docket documents Galderma Laboratories L.P. filed this citizen petition on June 10, 2009, requesting that FDA issue a guidance document establishing bioequivalence methodology for topical adapalene drugs intended to treat acne vulgaris and that FDA refrain from approving generic adapalene abbreviated new drug applic	505(q)	2009-06-12	Partially Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

69 trials from ClinicalTrials.gov, 61 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in Acne Vulgaris NCT00883233	Phase 3	Completed	Galderma R&D	123	2009-04 → 2009-09
Evaluation of Irritation by Two Facial Gels Applied to Opposite Sides of the Face NCT00919191	Phase 4	Completed	Bausch Health Americas, Inc.	26	2009-04 → 2009-05
Assessment of Subjects' Efficacy and Experiences Using Adapalene BPO Gel in the Treatment of Acne Vulgaris NCT01209949	Phase 4	Completed	Galderma R&D	30	2010-10 → 2011-01
A Treatment for Severe Inflammatory Acne Subjects NCT02899000	Phase 4	Completed	Galderma R&D	186	2016-07-29 → 2017-06-27
A Long Term Study of GK530G in Subjects With Acne Vulgaris NCT01910064	Phase 3	Completed	Galderma R&D	436	2013-05 → 2014-08
A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Facial Acne NCT00964223	Phase 4	Completed	Stiefel, a GSK Company	28	2009-07 → 2009-11
Efficacy and Tolerability of Nicotinamide Plus Cream for Moderate Acne Vulgaris in Indonesia NCT03626298	Phase 4	Completed	Rumah Sakit Pusat Angkatan Darat Gatot Soebroto	125	2016-08-01 → 2018-04-30
Long-term Study of Efficacy/Safety of Adapalene/Benzoyl Peroxide Topical Gel in Acne Vulgaris Subjects NCT00446043	Phase 3	Completed	Galderma R&D	452	2004-02-17 → 2005-05-23
Adapalene Gel 0.3% in the Treatment of Atrophic Acne Scars NCT01213199	Phase 2	Completed	Galderma R&D	20	2011-03 → 2012-09
Efficacy and Safety Study of GK530G Versus CD0271 0.1% Gel and CD1579 2.5% Gel in the Treatment of Acne Vulgaris.NCT02073448	Phase 3	Completed	Galderma R&D	417	2014-03 → 2014-10

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain10 active DMFs4 inactive

10 active API suppliers hold Drug Master Files for this ingredient.

FINORGA SASADAPALENE

DMF 87841990

ALIVUS LIFE SCIENCES LTDADAPALENE USP

DMF 187562005

HAS HEALTHCARE ADVANCED SYNTHESIS SAADAPALENE

DMF 188262005

EXCELLA GMBH AND CO KGADAPALENE

DMF 191692006

OLON SPAADAPALENE DRUG SUBSTANCE

DMF 196212006

TARO PHARMACEUTICAL INDUSTRIES LTDADAPALENE USP, MICRONIZED

DMF 212082008

MEDICHEM SAADAPALENE (MED-200025/E)

DMF 214802008

AARTI PHARMALABS LTDADAPALENE

DMF 227092009

MAITHRI DRUGS PRIVATE LTDADAPALENE USP

DMF 390632023

ALEMBIC PHARMACEUTICALS LTDADAPALENE USP

DMF 436232026

ZHEJIANG NEO DANKONG PHARMACEUTICAL CO LTDInactiveADAPALENE (NON-STERILE BULK DRUG SUBSTANCE)

DMF 188312005

ZYDUS LIFESCIENCES LTDInactiveADAPALENE USP

DMF 200642006

AMINO CHEMICALS LTDInactiveADAPALENE

DMF 201062006

ALP PHARM BEIJING CO LTDInactiveADAPALENE (DRUG SUBTANCE NON-STERILE)

DMF 235362010

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Jun 15, 2022	SUPPL -21	View Letter (PDF)
Mar 29, 2018	SUPPL -13	View Letter (PDF)
May 24, 2017	SUPPL -11	View Letter (PDF)
Mar 30, 2017	SUPPL -10	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#002 — 0.1%

RLD

0 patents0 exclusivities▴

GEL;TOPICAL | Approved: Jul 8, 2016

No patent or exclusivity listings for this strength.