HALOBETASOL PROPIONATE - Generic Drug Details

What are the generic drug sources for halobetasol propionate and what is the scope of patent protection?

Halobetasol propionate is the generic ingredient in five branded drugs marketed by Padagis Israel, Mayne Pharma, Cosette, Fougera Pharms, Taro, Sun Pharm Inds Inc, Bausch, Sun Pharm Industries, Encube, and Quagen, and is included in nineteen NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Halobetasol propionate has seventy-five patent family members in twenty-seven countries.

There are nine drug master file entries for halobetasol propionate. Nine suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for HALOBETASOL PROPIONATE

International Patents:	75
US Patents:	10
Tradenames:	5
Applicants:	10
NDAs:	19
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	20
Patent Applications:	7,010
Drug Prices:	Drug price trends for HALOBETASOL PROPIONATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for HALOBETASOL PROPIONATE
What excipients (inactive ingredients) are in HALOBETASOL PROPIONATE?	HALOBETASOL PROPIONATE excipients list
DailyMed Link:	HALOBETASOL PROPIONATE at DailyMed

See drug prices for HALOBETASOL PROPIONATE

Recent Clinical Trials for HALOBETASOL PROPIONATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Icahn School of Medicine at Mount Sinai	Phase 3
Citius Pharmaceuticals, Inc.	Phase 2
Taro Pharmaceuticals USA	Early Phase 1

See all HALOBETASOL PROPIONATE clinical trials

Generic filers with tentative approvals for HALOBETASOL PROPIONATE

Applicant	Application No.	Strength	Dosage Form
		UNKNOWN	UNKNOWN
		0.01%;0.045%	LOTION;TOPICAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for HALOBETASOL PROPIONATE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Paragraph IV (Patent) Challenges for HALOBETASOL PROPIONATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LEXETTE	Topical Foam	halobetasol propionate	0.05%	210566	1	2021-01-28
BRYHALI	Lotion	halobetasol propionate	0.01%	209355	1	2019-05-15
ULTRAVATE	Lotion	halobetasol propionate	0.05%	208183	1	2018-01-24

US Patents and Regulatory Information for HALOBETASOL PROPIONATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	BRYHALI	halobetasol propionate	LOTION;TOPICAL	209355-001	Nov 6, 2018		RX	Yes	Yes			Y
Mayne Pharma	LEXETTE	halobetasol propionate	AEROSOL, FOAM;TOPICAL	210566-001	May 24, 2018	AB	RX	Yes	Yes					Y
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019		RX	Yes	Yes			Y
Padagis Israel	HALOBETASOL PROPIONATE	halobetasol propionate	OINTMENT;TOPICAL	076872-001	Dec 16, 2004	AB	RX	No	Yes
Fougera Pharms	HALOBETASOL PROPIONATE	halobetasol propionate	OINTMENT;TOPICAL	076903-001	Dec 16, 2004		DISCN	No	No
Padagis Israel	HALOBETASOL PROPIONATE	halobetasol propionate	AEROSOL, FOAM;TOPICAL	215266-001	Aug 11, 2023	AB	RX	No	No
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019		RX	Yes	Yes			Y

Expired US Patents for HALOBETASOL PROPIONATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sun Pharm Inds Inc	ULTRAVATE	halobetasol propionate	OINTMENT;TOPICAL	019968-001	Dec 17, 1990
Sun Pharm Inds Inc	ULTRAVATE	halobetasol propionate	CREAM;TOPICAL	019967-001	Dec 27, 1990
Bausch	BRYHALI	halobetasol propionate	LOTION;TOPICAL	209355-001	Nov 6, 2018

International Patents for HALOBETASOL PROPIONATE

Country	Patent Number	Title	Estimated Expiration
Mexico	2015004863	COMPOSICION DE ESTEROIDE TOPICA Y METODO. (TOPICAL STEROID COMPOSITION AND METHOD.)
Slovenia	2643002
Brazil	112013012476	formulações farmacêuticas contendo corticosteróides para administração tópica
Japan	2015534980	外用ステロイド組成物および方法
South Korea	20180015281	국소 투여를 위한 코르티코스테로이드 함유 약학 제형 (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION)
Canada	3008753	COMPOSITION DE MOUSSE D'HALOBETASOL ET PROCEDE D'UTILISATION (HALOBETASOL FOAM COMPOSITION AND METHOD OF USE THEREOF)
Israel	226398	פורמולציות רקחייות המכילות קורטיקוסטראוידים למתן על העור (Pharmaceutical formulations containing corticosteroids for topical administration)