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.
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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 |
---|---|---|---|
Japan | 2018538326 | コルチコステロイドを含有する泡組成物及びその製造方法 | ⤷ Sign Up |
China | 108601726 | 含有皮质类固醇的泡沫组合物及其制备方法 (CORTICOSTEROID CONTAINING FOAM COMPOSITIONS AND METHOD OF MANUFACTURE THEREOF) | ⤷ Sign Up |
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 | ⤷ Sign Up |
South Korea | 20180098300 | 할로베타솔 발포체 조성물 및 이의 사용 방법 | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |