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 16^th, 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

Drug patent expirations by year for LEXETTE

Recent Clinical Trials for LEXETTE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Skin Sciences, PLLC	Phase 4

See all LEXETTE clinical trials

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
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Patent Expiration: ⤷ Sign Up

Corticosteroid containing foam compositions and method of manufacture thereof
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Patented Use: FOR THE TOPICAL TREATMENT OF PLAQUE PSORIASIS IN PATIENTS 18 YEARS OF AGE AND OLDER

FDA Regulatory Exclusivity protecting LEXETTE

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Glossary

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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.

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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
>Country	>Patent Number	>Title	>Estimated Expiration