Is there a generic for Adapalene?

Yes. The FDA Orange Book lists 10 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, 10 generics; first approved May 31, 1996; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 10 ANDA applications approved.

Earliest patent expiry Sep 15, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Sep 15, 2026

in 2 mo

Originator applications

Brand (NDA) products

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0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION	TOPICAL	Discontinued	—

Abbreviated applications

Generic (ANDA) products (10)

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	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Orange Book patent file

Listed patents

Listed patents (3)

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 2 mo	ProductU-1078
8709392	Sep 15, 2026	in 2 mo	ProductU-1078
7998467	May 31, 2028	in 1 yr 11 mo	ProductU-1078

FDA approval span

Approval history

First approval

May 31, 1996

30 yr 7 mo ago

Most recent approval

Jan 14, 2022

4 yr 7 mo ago

Approvals span 1996–2022 across 15 FDA applications.

Brand (NDA) 533%

Generic (ANDA) 1067%

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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