Is there a generic for Adapalene?

Yes. The FDA Orange Book lists 11 approved generic (ANDA) applications for Adapalene, referencing the brand DIFFERIN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Adapalene?

DIFFERIN (NDA 020380, GALDERMA LABS LP) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Adapalene?

The Orange Book lists 3 patents against Adapalene products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Adapalene are approved?

Adapalene is approved in the following dosage forms: cream, gel, lotion, solution.

FDA Orange Book · active-ingredient family

Adapalene

Adapalene: 5 brands, 11 generics; first approved May 31, 1996; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 11 ANDA applications approved.

Earliest patent expiry Sep 15, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Sep 15, 2026

in 1 mo

Brand (NDA) products

Originator applications

DIFFERINRLDRS
GALDERMA LABS LPNDA 0203802016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% GEL TOPICAL OTC —
DIFFERINRLD
GALDERMA LABS LPNDA 0225022010
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% LOTION TOPICAL Discontinued —
DIFFERINRLDRS
GALDERMA LABS LPNDA 0217532007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.3% GEL TOPICAL Rx AB
DIFFERINRLDRS
GALDERMA LABS LPNDA 0207482000
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% CREAM TOPICAL Rx AB
DIFFERINRLD
GALDERMA LABS LPNDA 0203381996
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% SOLUTION TOPICAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	GEL	TOPICAL	OTC	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	LOTION	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.3%	GEL	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	CREAM	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	SOLUTION	TOPICAL	Discontinued	—

Generic (ANDA) products (11)

Abbreviated applications

ADAPALENE
UNIQUEANDA 2195652026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% GEL TOPICAL OTC —
ADAPALENE
SUN PHARMA CANADAANDA 2159402022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% GEL TOPICAL OTC —
ADAPALENE
ALEMBICANDA 2135082020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.3% GEL TOPICAL Rx AB
ADAPALENE
WAYLIS THERAPANDA 2039812016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% SOLUTION TOPICAL Rx AB
ADAPALENE
SUN PHARMA CANADAANDA 2083222016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.3% GEL TOPICAL Rx AB
ADAPALENE
WAYLIS THERAPANDA 2045932016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% SOLUTION TOPICAL Rx AB
ADAPALENE
ACTAVIS MID ATLANTICANDA 2010002014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.3% GEL TOPICAL Rx AB
ADAPALENE
ENCUBE ETHICALSANDA 2002982012
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.3% GEL TOPICAL Rx AB
ADAPALENE
GLENMARK PHARMSANDA 0913142010
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% GEL TOPICAL OTC —
ADAPALENE
FOUGERA PHARMSANDA 0908242010
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% CREAM TOPICAL Rx AB
ADAPALENE
P AND LANDA 0909622010
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% GEL TOPICAL OTC —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	GEL	TOPICAL	OTC	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	GEL	TOPICAL	OTC	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.3%	GEL	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	SOLUTION	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.3%	GEL	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	SOLUTION	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.3%	GEL	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.3%	GEL	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	GEL	TOPICAL	OTC	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	CREAM	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	GEL	TOPICAL	OTC	—

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8435502	Sep 15, 2026	in 1 mo	ProductU-1078
8709392	Sep 15, 2026	in 1 mo	ProductU-1078
7998467	May 31, 2028	in 1 yr 10 mo	ProductU-1078

Approval history

FDA approval span

First approval

May 31, 1996

30 yr 7 mo ago

Most recent approval

Jun 30, 2026

1 mo ago

Approvals span 1996–2026 across 16 FDA applications.

Brand (NDA) 531%

Generic (ANDA) 1169%

Adapalene: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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