HALOBETASOL PROPIONATE - Generic Drug Details

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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:	6,771
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
⤷ Sign Up	⤷ Sign Up	UNKNOWN	UNKNOWN
⤷ Sign Up	⤷ Sign Up	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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mayne Pharma	LEXETTE	halobetasol propionate	AEROSOL, FOAM;TOPICAL	210566-001	May 24, 2018	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Bausch	BRYHALI	halobetasol propionate	LOTION;TOPICAL	209355-001	Nov 6, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fougera Pharms	HALOBETASOL PROPIONATE	halobetasol propionate	OINTMENT;TOPICAL	076903-001	Dec 16, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Padagis Israel	HALOBETASOL PROPIONATE	halobetasol propionate	CREAM;TOPICAL	077123-001	Dec 16, 2004	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cosette	HALOBETASOL PROPIONATE	halobetasol propionate	CREAM;TOPICAL	078162-001	Apr 24, 2007	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for HALOBETASOL PROPIONATE

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

International Patents for HALOBETASOL PROPIONATE

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Country	Patent Number	Title	Estimated Expiration
Singapore	11201805109Y	HALOBETASOL FOAM COMPOSITION AND METHOD OF USE THEREOF	⤷ Sign Up
Japan	6385938		⤷ Sign Up
Russian Federation	2568598	ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ, СОДЕРЖАЩИЕ КОРТИКОСТЕРОИДЫ, ДЛЯ ТОПИКАЛЬНОГО ПРИМЕНЕНИЯ (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL APPLICATION)	⤷ Sign Up
Russian Federation	2013128607	ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ, СОДЕРЖАЩИЕ КОРТИКОСТЕРОИДЫ, ДЛЯ ТОПИКАЛЬНОГО ПРИМЕНЕНИЯ	⤷ Sign Up
Japan	2018538326	コルチコステロイドを含有する泡組成物及びその製造方法	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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