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Last Updated: October 5, 2024

LEXETTE Drug Patent Profile


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Which patents cover Lexette, and what generic alternatives are available?

Lexette is a drug marketed by Mayne Pharma and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-seven patent family members in fourteen countries.

The generic ingredient in LEXETTE is halobetasol propionate. There are nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the halobetasol propionate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Lexette

A generic version of LEXETTE was approved as halobetasol propionate by FOUGERA PHARMS on December 16th, 2004.

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Summary for LEXETTE
International Patents:27
US Patents:2
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 49
Clinical Trials: 1
Patent Applications: 4,752
Drug Prices: Drug price information for LEXETTE
What excipients (inactive ingredients) are in LEXETTE?LEXETTE excipients list
DailyMed Link:LEXETTE at DailyMed
Drug patent expirations by year for LEXETTE
Drug Prices for LEXETTE

See drug prices for LEXETTE

Recent Clinical Trials for LEXETTE

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

SponsorPhase
Skin Sciences, PLLCPhase 4

See all LEXETTE clinical trials

Paragraph IV (Patent) Challenges for LEXETTE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LEXETTE Topical Foam halobetasol propionate 0.05% 210566 1 2021-01-28

US Patents and Regulatory Information for LEXETTE

LEXETTE is protected by two US patents and one FDA Regulatory Exclusivity.

Patents protecting LEXETTE

Halobetasol foam composition and method of use thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Corticosteroid containing foam compositions and method of manufacture thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: FOR THE TOPICAL TREATMENT OF PLAQUE PSORIASIS IN PATIENTS 18 YEARS OF AGE AND OLDER

FDA Regulatory Exclusivity protecting LEXETTE

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mayne Pharma LEXETTE halobetasol propionate AEROSOL, FOAM;TOPICAL 210566-001 May 24, 2018 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  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
Mayne Pharma LEXETTE halobetasol propionate AEROSOL, FOAM;TOPICAL 210566-001 May 24, 2018 AB RX Yes 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

International Patents for LEXETTE

See the table below for patents covering LEXETTE around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2017103719 ⤷  Sign Up
Singapore 11201805109Y HALOBETASOL FOAM COMPOSITION AND METHOD OF USE THEREOF ⤷  Sign Up
Australia 2016372790 Corticosteroid containing foam compositions and method of manufacture thereof ⤷  Sign Up
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 ⤷  Sign Up
Mexico 2018007340 COMPOSICIONES DE ESPUMA QUE CONTIENEN CORTICOSTEROIDES Y METODO DE MANUFACTURA DE LAS MISMAS. (CORTICOSTEROID CONTAINING FOAM COMPOSITIONS AND METHOD OF MANUFACTURE THEREOF.) ⤷  Sign Up
Singapore 11201805111V CORTICOSTEROID CONTAINING FOAM COMPOSITIONS AND METHOD OF MANUFACTURE THEREOF ⤷  Sign Up
Eurasian Patent Organization 035300 ВСПЕНИВАЕМАЯ КОМПОЗИЦИЯ ГАЛОБЕТАЗОЛА (ВАРИАНТЫ) И СПОСОБ ЛЕЧЕНИЯ (HALOBETASOL FOAM COMPOSITION (EMBODIMENTS) AND METHOD OF TREATMENT) ⤷  Sign Up
>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.