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Last Updated: February 28, 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, Quagen, and Vertice, 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
⤷  Try a Trial⤷  Try a TrialUNKNOWNUNKNOWN
⤷  Try a Trial⤷  Try a Trial0.01%;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
Padagis Israel HALOBETASOL PROPIONATE halobetasol propionate LOTION;TOPICAL 211464-001 Jun 3, 2020 DISCN 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
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
Bausch DUOBRII halobetasol propionate; tazarotene LOTION;TOPICAL 209354-001 Apr 25, 2019 RX Yes Yes ⤷  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 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

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

International Patents for halobetasol propionate

Country Patent Number Title Estimated Expiration
Spain 2770325 ⤷  Try a Trial
Canada 3008756 CORTICOSTEROIDE CONTENANT DES COMPOSITIONS DE MOUSSE ET SON PROCEDE DE FABRICATION (CORTICOSTEROID CONTAINING FOAM COMPOSITIONS AND METHOD OF MANUFACTURE THEREOF) ⤷  Try a Trial
Brazil 112018012347 método para a fabricação de corrente única de uma composição espumante, composição espumante e método para tratar um indivíduo tendo, ou em risco de ter, uma condição responsiva a corticosteroides ⤷  Try a Trial
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) ⤷  Try a Trial
Hong Kong 1214154 局部類固醇組合物和方法 (TOPICAL STEROID COMPOSITION AND METHOD) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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