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Last Updated: June 30, 2022

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. Twelve suppliers are listed for this compound. Additional details are available on the halobetasol propionate profile page.

Summary for LEXETTE
International Patents:27
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 1
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

Pharmacology for LEXETTE
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Corticosteroid containing foam compositions and method of manufacture thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: 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
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
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
Mayne Pharma LEXETTE halobetasol propionate AEROSOL, FOAM;TOPICAL 210566-001 May 24, 2018 RX Yes Yes 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

International Patents for LEXETTE

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

Country Patent Number Title Estimated Expiration
South Korea 20180098299 코르티코스테로이드 함유 발포체 조성물 및 이의 제조 방법 See Plans and Pricing
China 108601733 卤倍他索泡沫组合物及其使用方法 (HALOBETASOL FOAM COMPOSITION AND METHOD OF USE THEREOF) See Plans and Pricing
European Patent Office 3389631 COMPOSITION DE MOUSSE D'HALOBÉTASOL ET PROCÉDÉ D'UTILISATION (HALOBETASOL FOAM COMPOSITION AND METHOD OF USE THEREOF) See Plans and Pricing
Australia 2016372790 Corticosteroid containing foam compositions and method of manufacture thereof See Plans and Pricing
Australia 2016372789 Halobetasol foam composition and method of use thereof See Plans and Pricing
Brazil 112018012349 composição farmacêutica espumante, composição espumante de armazenamento estável e método para tratar um indivíduo com, ou em risco de ter, uma doença, condição ou distúrbio da pele See Plans and Pricing
Philippines 12018501278 HALOBETASOL FOAM COMPOSITION AND METHOD OF USE THEREOF See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Johnson and Johnson
Mallinckrodt
Express Scripts
Moodys
Boehringer Ingelheim

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