Is there a generic for Halobetasol propionate?

Yes. The FDA Orange Book lists 13 approved generic (ANDA) applications for Halobetasol propionate, referencing the brand BRYHALI. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Halobetasol propionate?

BRYHALI (NDA 209355, BAUSCH) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Halobetasol propionate?

The Orange Book lists 10 patents against Halobetasol propionate products, with the earliest listed expiry in 2031. 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 Halobetasol propionate are approved?

Halobetasol propionate is approved in the following dosage forms: aerosol, foam, cream, lotion, ointment.

FDA Orange Book · active-ingredient family

Halobetasol propionate

Halobetasol propionate: 5 brands, 13 generics; first approved Dec 17, 1990; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 13 ANDA applications approved.

Earliest patent expiry Nov 02, 2031

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Nov 02, 2031

in 5 yr 1 mo

Brand (NDA) products

Originator applications

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BRYHALIRLDRS
BAUSCHNDA 2093552018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% LOTION TOPICAL Rx -
LEXETTERLD
MAYNE PHARMANDA 2105662018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% AEROSOL, FOAM TOPICAL Discontinued -
ULTRAVATERLDRS
LACER PHARMANDA 2081832015
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% LOTION TOPICAL Rx -
ULTRAVATERLD
SUN PHARM INDS INCNDA 0199671990
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Discontinued -
ULTRAVATERLD
SUN PHARM INDS INCNDA 0199681990
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
0.01%	LOTION	TOPICAL	Rx	-

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%	LOTION	TOPICAL	Rx	-

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	-

Generic (ANDA) products (13)

Abbreviated applications

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HALOBETASOL PROPIONATERS
PADAGIS ISRAELANDA 2152662023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% AEROSOL, FOAM TOPICAL Rx -
HALOBETASOL PROPIONATE
QUAGENANDA 2135602020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% OINTMENT TOPICAL Rx AB
HALOBETASOL PROPIONATE
PADAGIS ISRAELANDA 2114642020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% LOTION TOPICAL Discontinued -
HALOBETASOL PROPIONATE
ENCUBEANDA 2099782018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% OINTMENT TOPICAL Rx AB
HALOBETASOL PROPIONATERS
COSETTE PHARMS NCANDA 0781622007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Rx AB
HALOBETASOL PROPIONATE
COSETTE PHARMS NCANDA 0777212006
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% OINTMENT TOPICAL Discontinued -
HALOBETASOL PROPIONATE
SUN PHARMA CANADAANDA 0772272005
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Discontinued -
HALOBETASOL PROPIONATE
COSETTE PHARMS NCANDA 0771092005
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% OINTMENT TOPICAL Rx AB
HALOBETASOL PROPIONATE
FOUGERA PHARMSANDA 0770012004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Rx AB
HALOBETASOL PROPIONATE
PADAGIS ISRAELANDA 0771232004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% CREAM TOPICAL Rx AB
HALOBETASOL PROPIONATE
FOUGERA PHARMSANDA 0769032004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% OINTMENT TOPICAL Discontinued -
HALOBETASOL PROPIONATERS
PADAGIS ISRAELANDA 0768722004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% OINTMENT TOPICAL Rx AB
HALOBETASOL PROPIONATE
SUN PHARMA CANADAANDA 0769942004
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%	AEROSOL, FOAM	TOPICAL	Rx	-

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%	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%	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	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%	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%	OINTMENT	TOPICAL	Discontinued	-

Patent & exclusivity timeline

Protection horizon

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Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

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Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10478502	Nov 02, 2031	in 5 yr 1 mo	ProductU-2625
11986527	Nov 02, 2031	in 5 yr 1 mo	U-2625
11839656	Nov 02, 2031	in 5 yr 1 mo	U-2625
11957753	Nov 02, 2031	in 5 yr 1 mo	Product
12076403	Nov 02, 2031	in 5 yr 1 mo	Product
8809307	Nov 02, 2031	in 5 yr 1 mo	Product
8962028	Jun 19, 2033	in 6 yr 9 mo	ProductU-1775
11020407	Nov 30, 2036	in 10 yr 3 mo	ProductU-3143
10857159	Nov 30, 2036	in 10 yr 3 mo	Product
10857159*PED	May 30, 2037	in 10 yr 9 mo

Approval history

FDA approval span

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First approval

Dec 17, 1990

36 yr 5 mo ago

Most recent approval

Aug 11, 2023

3 yr 3 mo ago

Approvals span 1990–2023 across 18 FDA applications.

Brand (NDA) 528%

Generic (ANDA) 1372%

Halobetasol propionate: 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.

Related FDA reference tools

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