LEXETTE Drug Patent Profile
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When do Lexette patents expire, and when can generic versions of Lexette launch?
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.
Summary for LEXETTE
International Patents: | 27 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 49 |
Clinical Trials: | 1 |
Patent Applications: | 5,226 |
Drug Prices: | Drug price information for LEXETTE |
What excipients (inactive ingredients) are in LEXETTE? | LEXETTE excipients list |
DailyMed Link: | LEXETTE at DailyMed |
Recent Clinical Trials for LEXETTE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Skin Sciences, PLLC | Phase 4 |
Pharmacology for LEXETTE
Drug Class | Corticosteroid |
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Corticosteroid containing foam compositions and method of manufacture thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 | ||
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 | ||
Mayne Pharma | LEXETTE | halobetasol propionate | AEROSOL, FOAM;TOPICAL | 210566-001 | May 24, 2018 | AB | RX | Yes | Yes | ⤷ 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 |
International Patents for LEXETTE
See the table below for patents covering LEXETTE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 20180098300 | 할로베타솔 발포체 조성물 및 이의 사용 방법 | ⤷ 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 |
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) | ⤷ Try a Trial |
European Patent Office | 3389631 | COMPOSITION DE MOUSSE D'HALOBÉTASOL ET PROCÉDÉ D'UTILISATION (HALOBETASOL FOAM COMPOSITION AND METHOD OF USE THEREOF) | ⤷ Try a Trial |
Australia | 2016372790 | Corticosteroid containing foam compositions and method of manufacture thereof | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |