Halobetasol propionate - Generic Drug Details

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What are the generic sources for halobetasol propionate and what is the scope of freedom to operate?

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, Mical Pharms, Encube, and Quagen, and is included in nineteen NDAs. There are thirteen 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:	13
Tradenames:	5
Applicants:	10
NDAs:	19
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	21
Patent Applications:	6,827
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
Dermatology Consulting Services, PLLC	Phase 4
Icahn School of Medicine at Mount Sinai	Phase 3
Citius Pharmaceuticals, Inc.	Phase 2

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
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019		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	Y			⤷ Sign Up
Quagen	HALOBETASOL PROPIONATE	halobetasol propionate	OINTMENT;TOPICAL	213560-001	Oct 6, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bausch	BRYHALI	halobetasol propionate	LOTION;TOPICAL	209355-001	Nov 6, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bausch	BRYHALI	halobetasol propionate	LOTION;TOPICAL	209355-001	Nov 6, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Padagis Israel	HALOBETASOL PROPIONATE	halobetasol propionate	LOTION;TOPICAL	211464-001	Jun 3, 2020		DISCN	No	No	⤷ 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	CREAM;TOPICAL	019967-001	Dec 27, 1990	⤷ Sign Up	⤷ Sign Up
Sun Pharm Inds Inc	ULTRAVATE	halobetasol propionate	OINTMENT;TOPICAL	019968-001	Dec 17, 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
Russian Federation	2568598	ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ, СОДЕРЖАЩИЕ КОРТИКОСТЕРОИДЫ, ДЛЯ ТОПИКАЛЬНОГО ПРИМЕНЕНИЯ (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL APPLICATION)	⤷ Sign Up
China	108601726	含有皮质类固醇的泡沫组合物及其制备方法 (CORTICOSTEROID CONTAINING FOAM COMPOSITIONS AND METHOD OF MANUFACTURE THEREOF)	⤷ Sign Up
China	104884043	Topical steroid composition and method	⤷ Sign Up
Canada	2888853	PROCEDE ET COMPOSITION DE STEROIDE TOPIQUE (TOPICAL STEROID COMPOSITION AND METHOD)	⤷ Sign Up
Philippines	12015500859	TOPICAL STEROID COMPOSITION AND METHOD	⤷ Sign Up
Malaysia	188053	CORTICOSTEROID CONTAINING FOAM COMPOSITIONS AND METHOD OF MANUFACTURE THEREOF	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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