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Last Updated: February 4, 2023

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 Mayne Pharma, Cosette, Fougera Pharms, Padagis Israel, Taro, Sun Pharm Inds Inc, Bausch, Sun Pharm Industries, Pai Holdings Pharm, and Quagen, and is included in eighteen NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Halobetasol propionate has sixty-seven patent family members in twenty-one countries.

There are nine drug master file entries for halobetasol propionate. Nine suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for halobetasol propionate

See drug prices for halobetasol propionate

Recent Clinical Trials for halobetasol propionate

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

SponsorPhase
Icahn School of Medicine at Mount SinaiPhase 3
Citius Pharmaceuticals, Inc.Phase 2
Taro Pharmaceuticals USAEarly Phase 1

See all halobetasol propionate clinical trials

Generic filers with tentative approvals for HALOBETASOL PROPIONATE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing0.05%FOAM;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
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
Padagis Israel HALOBETASOL PROPIONATE halobetasol propionate LOTION;TOPICAL 211464-001 Jun 3, 2020 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Taro HALOBETASOL PROPIONATE halobetasol propionate OINTMENT;TOPICAL 076994-001 Dec 16, 2004 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bausch DUOBRII halobetasol propionate; tazarotene LOTION;TOPICAL 209354-001 Apr 25, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Padagis Israel HALOBETASOL PROPIONATE halobetasol propionate CREAM;TOPICAL 077123-001 Dec 16, 2004 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cosette HALOBETASOL PROPIONATE halobetasol propionate OINTMENT;TOPICAL 077721-001 Sep 7, 2006 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mayne Pharma LEXETTE halobetasol propionate AEROSOL, FOAM;TOPICAL 210566-001 May 24, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pai Holdings Pharm HALOBETASOL PROPIONATE halobetasol propionate OINTMENT;TOPICAL 209978-001 Mar 20, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

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

International Patents for halobetasol propionate

Country Patent Number Title Estimated Expiration
Philippines 12015500859 TOPICAL STEROID COMPOSITION AND METHOD See Plans and Pricing
European Patent Office 2643002 FORMULATIONS PHARMACEUTIQUES CONTENANT DES CORTICOSTÉROÏDES POUR ADMINISTRATION TOPIQUE (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION) See Plans and Pricing
Mexico 346961 FORMULACIONES FARMACEUTICAS QUE CONTIENEN CORTICOSTEROIDES PARA LA ADMINISTRACION TOPICA. (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION.) See Plans and Pricing
Russian Federation 2013128607 ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ, СОДЕРЖАЩИЕ КОРТИКОСТЕРОИДЫ, ДЛЯ ТОПИКАЛЬНОГО ПРИМЕНЕНИЯ See Plans and Pricing
World Intellectual Property Organization (WIPO) 2014062817 See Plans and Pricing
Japan 6111007 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2017103720 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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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.