lexette Drug Patent Profile
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Which patents cover Lexette, 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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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 |
|---|---|---|---|
| European Patent Office | 3389627 | CORTICOSTÉROÏDE CONTENANT DES COMPOSITIONS DE MOUSSE ET SON PROCÉDÉ DE FABRICATION (CORTICOSTEROID CONTAINING FOAM COMPOSITIONS AND METHOD OF MANUFACTURE THEREOF) | ⤷ Sign Up |
| Malaysia | 188053 | CORTICOSTEROID CONTAINING FOAM COMPOSITIONS AND METHOD OF MANUFACTURE THEREOF | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2017103720 | ⤷ Sign Up | |
| European Patent Office | 3389631 | COMPOSITION DE MOUSSE D'HALOBÉTASOL ET PROCÉDÉ D'UTILISATION (HALOBETASOL FOAM COMPOSITION AND METHOD OF USE THEREOF) | ⤷ Sign Up |
| Japan | 2018538327 | ハロベタゾール泡組成物及びその使用方法 | ⤷ 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 |
| >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.
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