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Last Updated: October 18, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210566


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NDA 210566 describes LEXETTE, which is a drug marketed by Mayne Pharma and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the LEXETTE profile page.

The generic ingredient in LEXETTE is halobetasol propionate. There are nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the halobetasol propionate profile page.
Summary for 210566
Tradename:LEXETTE
Applicant:Mayne Pharma
Ingredient:halobetasol propionate
Patents:2
Pharmacology for NDA: 210566
Suppliers and Packaging for NDA: 210566
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEXETTE halobetasol propionate AEROSOL, FOAM;TOPICAL 210566 NDA Mayne Pharma 51862-604 51862-604-02 2 CANISTER in 1 CARTON (51862-604-02) > 50 g in 1 CANISTER
LEXETTE halobetasol propionate AEROSOL, FOAM;TOPICAL 210566 NDA Mayne Pharma 51862-604 51862-604-33 1 CANISTER in 1 CARTON (51862-604-33) > 17 g in 1 CANISTER
Paragraph IV (Patent) Challenges for 210566
Tradename Dosage Ingredient NDA Submissiondate
LEXETTE AEROSOL, FOAM;TOPICAL halobetasol propionate 210566 2021-01-28

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, FOAM;TOPICALStrength0.05%
Approval Date:May 24, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:May 24, 2021
Regulatory Exclusivity Use:NEW DOSAGE FORM
Patent:⤷  Free Forever TrialPatent Expiration:May 30, 2037Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Free Forever TrialPatent Expiration:Nov 30, 2036Product Flag?YSubstance Flag?Delist Request?
Patented Use:FOR THE TOPICAL TREATMENT OF PLAQUE PSORIASIS IN PATIENTS 18 YEARS OF AGE AND OLDER

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Colorcon
Moodys
Johnson and Johnson
McKesson
McKinsey

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