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Last Updated: June 13, 2024

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, 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.

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
⤷  Sign Up⤷  Sign UpUNKNOWNUNKNOWN
⤷  Sign Up⤷  Sign Up0.01%;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
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
Bausch DUOBRII halobetasol propionate; tazarotene LOTION;TOPICAL 209354-001 Apr 25, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Bausch DUOBRII halobetasol propionate; tazarotene LOTION;TOPICAL 209354-001 Apr 25, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bausch DUOBRII halobetasol propionate; tazarotene LOTION;TOPICAL 209354-001 Apr 25, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
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 ⤷  Sign Up
Mayne Pharma LEXETTE halobetasol propionate AEROSOL, FOAM;TOPICAL 210566-001 May 24, 2018 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  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

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

International Patents for halobetasol propionate

Country Patent Number Title Estimated Expiration
Philippines 12018501277 CORTICOSTEROID CONTAINING FOAM COMPOSITIONS AND METHOD OF MANUFACTURE THEREOF ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2017103719 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2012087443 ⤷  Sign Up
Mexico 346961 FORMULACIONES FARMACEUTICAS QUE CONTIENEN CORTICOSTEROIDES PARA LA ADMINISTRACION TOPICA. (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION.) ⤷  Sign Up
Mexico 2013005764 FORMULACIONES FARMACEUTICAS QUE CONTIENEN CORTICOSTEROIDES PARA LA ADMINISTRACION TOPICA. (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION.) ⤷  Sign Up
South Korea 20150069005 국소 스테로이드 조성물 및 방법 (TOPICAL STEROID COMPOSITION AND METHOD) ⤷  Sign Up
Lithuania 2643002 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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