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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Questions you can ask:
- What is the 5 year forecast for LEXETTE?
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- What is Average Wholesale Price for LEXETTE?
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 |
Recent Clinical Trials for LEXETTE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Skin Sciences, PLLC | Phase 4 |
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 |