You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: May 3, 2024

Halobetasol propionate - Generic Drug Details

✉ Email this page to a colleague

« Back to Dashboard

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, 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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or 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
Bausch	BRYHALI	halobetasol propionate	LOTION;TOPICAL	209355-001	Nov 6, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Cosette	HALOBETASOL PROPIONATE	halobetasol propionate	OINTMENT;TOPICAL	077109-001	Jun 14, 2005	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Fougera Pharms	HALOBETASOL PROPIONATE	halobetasol propionate	CREAM;TOPICAL	077001-001	Dec 16, 2004	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mayne Pharma	LEXETTE	halobetasol propionate	AEROSOL, FOAM;TOPICAL	210566-001	May 24, 2018	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Quagen	HALOBETASOL PROPIONATE	halobetasol propionate	OINTMENT;TOPICAL	213560-001	Oct 6, 2020	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ 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

Subscribe to access the full database, or Try a Trial
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

Subscribe to access the full database, or Try a Trial
Country	Patent Number	Title	Estimated Expiration
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
South Korea	20180098300	할로베타솔 발포체 조성물 및 이의 사용 방법	⤷ Try a Trial
Singapore	11201805111V	CORTICOSTEROID CONTAINING FOAM COMPOSITIONS AND METHOD OF MANUFACTURE THEREOF	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2014062817		⤷ Try a Trial
Australia	2016372789	Halobetasol foam composition and method of use thereof	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.