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

Last Updated: March 28, 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.

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
Bausch DUOBRII halobetasol propionate; tazarotene LOTION;TOPICAL 209354-001 Apr 25, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bausch DUOBRII halobetasol propionate; tazarotene LOTION;TOPICAL 209354-001 Apr 25, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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
Bausch DUOBRII halobetasol propionate; tazarotene LOTION;TOPICAL 209354-001 Apr 25, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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
Taro HALOBETASOL PROPIONATE halobetasol propionate OINTMENT;TOPICAL 076994-001 Dec 16, 2004 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

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
Poland 2643002 ⤷  Try a Trial
Lithuania 2643002 ⤷  Try a Trial
Singapore 11201805109Y HALOBETASOL FOAM COMPOSITION AND METHOD OF USE THEREOF ⤷  Try a Trial
Mexico 346961 FORMULACIONES FARMACEUTICAS QUE CONTIENEN CORTICOSTEROIDES PARA LA ADMINISTRACION TOPICA. (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION.) ⤷  Try a Trial
European Patent Office 3389627 CORTICOSTÉROÏDE CONTENANT DES COMPOSITIONS DE MOUSSE ET SON PROCÉDÉ DE FABRICATION (CORTICOSTEROID CONTAINING FOAM COMPOSITIONS AND METHOD OF MANUFACTURE THEREOF) ⤷  Try a Trial
South Korea 101967121 ⤷  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.