Is there a generic for Desonide?

Yes. The FDA Orange Book lists 20 approved generic (ANDA) applications for Desonide, referencing the brand DESONATE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Desonide?

DESONATE (NDA 021844, LEO PHARMA AS) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Desonide?

The Orange Book lists 1 patent against Desonide products, with the earliest listed expiry in 2027. 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 Desonide are approved?

Desonide is approved in the following dosage forms: aerosol, foam, cream, gel, lotion, ointment.

FDA Orange Book · active-ingredient family

Desonide

Desonide: 5 brands, 20 generics; first approved Dec 14, 1984; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 20 ANDA applications approved.

Earliest patent expiry Aug 13, 2027

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Aug 13, 2027

in 1 yr

Brand (NDA) products

Originator applications

DESONATERLD
LEO PHARMA ASNDA 0218442006
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% GEL TOPICAL Discontinued —
VERDESORLD
GENUSNDA 0219782006
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% AEROSOL, FOAM TOPICAL Discontinued —
DESONIDERLD
PADAGIS USNDA 017010—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Discontinued —
DESONIDERLDRS
PADAGIS USNDA 017426—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% OINTMENT TOPICAL Rx AB
DESOWEN
GALDERMA LABS LPNDA 0190481984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	GEL	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	AEROSOL, FOAM	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	CREAM	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	OINTMENT	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	CREAM	TOPICAL	Rx	AB

Generic (ANDA) products (20)

Abbreviated applications

DESONIDE
ALEMBICANDA 2143962022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Rx AB
DESONIDERS
ALEMBICANDA 2136322020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% LOTION TOPICAL Rx AB
DESONIDERS
SENORES PHARMSANDA 2024702020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% GEL TOPICAL Rx —
DESONIDERS
CADILAANDA 2101982019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Rx AB
DESONIDE
ALEMBICANDA 2124732019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% OINTMENT TOPICAL Rx AB
DESONIDE
PAI HOLDINGS PHARMANDA 2120022019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% OINTMENT TOPICAL Discontinued —
DESONIDE
ENCUBE ETHICALSANDA 2109982019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% OINTMENT TOPICAL Rx AB
DESONIDE
ENCUBEANDA 2078552017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% LOTION TOPICAL Discontinued —
DESONIDE
GLENMARK SPECLTANDA 2094942017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% LOTION TOPICAL Discontinued —
DESONIDE
GLENMARK PHARMS LTDANDA 2099962017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% OINTMENT TOPICAL Discontinued —
DESONIDE
GLENMARK SPECLTANDA 2097292017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Discontinued —
DESONIDE
HIKMAANDA 2088362017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% OINTMENT TOPICAL Discontinued —
DESONIDE
TAROANDA 2021612014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% LOTION TOPICAL Rx AB
DESONIDE
FOUGERA PHARMSANDA 0758602002
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% LOTION TOPICAL Rx AB
DESONIDE
FOUGERA PHARMSANDA 0757512001
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% OINTMENT TOPICAL Rx AB
DESONIDE
SUN PHARMA CANADAANDA 0742541994
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% OINTMENT TOPICAL Rx AB
DESONIDE
COSETTE PHARMS NCANDA 0740271992
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Rx AB
DESONIDE
SUN PHARMA CANADAANDA 0735481992
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Rx AB
DESOWEN
GALDERMA LABS LPANDA 0723541992
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% LOTION TOPICAL Discontinued —
DESOWEN
GALDERMA LABS LPANDA 0714251988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% OINTMENT TOPICAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	CREAM	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	LOTION	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	GEL	TOPICAL	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	CREAM	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	OINTMENT	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	OINTMENT	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	OINTMENT	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	LOTION	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	LOTION	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	OINTMENT	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	CREAM	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	OINTMENT	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	LOTION	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	LOTION	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	OINTMENT	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	OINTMENT	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	CREAM	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	CREAM	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	LOTION	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	OINTMENT	TOPICAL	Discontinued	—

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
8460641	Aug 13, 2027	in 1 yr	ProductU-1412

Approval history

FDA approval span

First approval

Dec 14, 1984

42 yr 3 mo ago

Most recent approval

Dec 08, 2022

3 yr 9 mo ago

Approvals span 1984–2022 across 25 FDA applications.

Brand (NDA) 520%

Generic (ANDA) 2080%

Desonide: 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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