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 is approved as 5 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:BRYHALI · NDA 209355

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · aerosol, foam, cream, lotion, ointment

Product	Applicant	Application	TE	Approved
BRYHALIRLD	BAUSCH	NDA 209355	—	Nov 06, 2018
LEXETTERLD	MAYNE PHARMA	NDA 210566	—	May 24, 2018
ULTRAVATERLD	LACER PHARMA	NDA 208183	—	Nov 06, 2015
ULTRAVATERLD	SUN PHARM INDS INC	NDA 019967	—	Dec 27, 1990
ULTRAVATERLD	SUN PHARM INDS INC	NDA 019968	—	Dec 17, 1990

Generic (ANDA) products (13)

Product	Applicant	Application	TE	Approved
HALOBETASOL PROPIONATE	PADAGIS ISRAEL	ANDA 215266	—	Aug 11, 2023
HALOBETASOL PROPIONATE	QUAGEN	ANDA 213560	AB	Oct 06, 2020
HALOBETASOL PROPIONATE	PADAGIS ISRAEL	ANDA 211464	—	Jun 03, 2020
HALOBETASOL PROPIONATE	ENCUBE	ANDA 209978	—	Mar 20, 2018
HALOBETASOL PROPIONATE	COSETTE PHARMS NC	ANDA 078162	AB	Apr 24, 2007
HALOBETASOL PROPIONATE	COSETTE	ANDA 077721	—	Sep 07, 2006
HALOBETASOL PROPIONATE	SUN PHARMA CANADA	ANDA 077227	—	Aug 04, 2005
HALOBETASOL PROPIONATE	COSETTE PHARMS NC	ANDA 077109	AB	Jun 14, 2005
HALOBETASOL PROPIONATE	FOUGERA PHARMS	ANDA 077001	AB	Dec 16, 2004
HALOBETASOL PROPIONATE	PADAGIS ISRAEL	ANDA 077123	AB	Dec 16, 2004
HALOBETASOL PROPIONATE	FOUGERA PHARMS	ANDA 076903	—	Dec 16, 2004
HALOBETASOL PROPIONATE	PADAGIS ISRAEL	ANDA 076872	AB	Dec 16, 2004
HALOBETASOL PROPIONATE	SUN PHARMA CANADA	ANDA 076994	—	Dec 16, 2004

Listed patents (10)

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 5 mo	ProductU-2625
11986527	Nov 02, 2031	in 5 yr 5 mo	U-2625
11839656	Nov 02, 2031	in 5 yr 5 mo	U-2625
11957753	Nov 02, 2031	in 5 yr 5 mo	Product
12076403	Nov 02, 2031	in 5 yr 5 mo	Product
8809307	Nov 02, 2031	in 5 yr 5 mo	Product
8962028	Jun 19, 2033	in 7 yr 1 mo	ProductU-1775
11020407	Nov 30, 2036	in 10 yr 7 mo	ProductU-3143
10857159	Nov 30, 2036	in 10 yr 7 mo	Product
10857159*PED	May 30, 2037	in 11 yr 1 mo

Halobetasol propionate — frequently asked questions

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

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