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Last Updated: April 19, 2024

HALOBETASOL PROPIONATE - Generic Drug Details

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What are the generic 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
⤷ Try a Trial	⤷ Try a Trial	UNKNOWN	UNKNOWN
⤷ Try a Trial	⤷ Try a Trial	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
Bausch	BRYHALI	halobetasol propionate	LOTION;TOPICAL	209355-001	Nov 6, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Sun Pharm Inds Inc	ULTRAVATE	halobetasol propionate	OINTMENT;TOPICAL	019968-001	Dec 17, 1990		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Cosette	HALOBETASOL PROPIONATE	halobetasol propionate	CREAM;TOPICAL	078162-001	Apr 24, 2007	AB	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bausch	BRYHALI	halobetasol propionate	LOTION;TOPICAL	209355-001	Nov 6, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
>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	⤷ Try a Trial	⤷ Try a Trial
Sun Pharm Inds Inc	ULTRAVATE	halobetasol propionate	CREAM;TOPICAL	019967-001	Dec 27, 1990	⤷ Try a Trial	⤷ Try a Trial
Bausch	BRYHALI	halobetasol propionate	LOTION;TOPICAL	209355-001	Nov 6, 2018	⤷ Try a Trial	⤷ Try a Trial
>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
European Patent Office	2643002	FORMULATIONS PHARMACEUTIQUES CONTENANT DES CORTICOSTÉROÏDES POUR ADMINISTRATION TOPIQUE (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION)	⤷ Try a Trial
Eurasian Patent Organization	201891352	ВСПЕНИВАЮЩИЕСЯ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ КОРТИКОСТЕРОИД, И СПОСОБ ИХ ПРОИЗВОДСТВА	⤷ Try a Trial
South Korea	101832041		⤷ Try a Trial
Brazil	112018012349	composição farmacêutica espumante, composição espumante de armazenamento estável e método para tratar um indivíduo com, ou em risco de ter, uma doença, condição ou distúrbio da pele	⤷ Try a Trial
India	4160DEN2015		⤷ Try a Trial
European Patent Office	2919753	PROCÉDÉ ET COMPOSITION DE STÉROÏDE TOPIQUE (TOPICAL STEROID COMPOSITION AND METHOD)	⤷ Try a Trial
Mexico	2018007340	COMPOSICIONES DE ESPUMA QUE CONTIENEN CORTICOSTEROIDES Y METODO DE MANUFACTURA DE LAS MISMAS. (CORTICOSTEROID CONTAINING FOAM COMPOSITIONS AND METHOD OF MANUFACTURE THEREOF.)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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