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Last Updated: April 4, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022013


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NDA 022013 describes OLUX E, which is a drug marketed by Mylan and is included in one NDA. It is available from three suppliers. There are four patents protecting this drug. Additional details are available on the OLUX E profile page.

The generic ingredient in OLUX E is clobetasol propionate. There are fourteen drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
Summary for 022013
Tradename:OLUX E
Applicant:Mylan
Ingredient:clobetasol propionate
Patents:4
Formulation / Manufacturing:see details
Pharmacology for NDA: 022013
Medical Subject Heading (MeSH) Categories for 022013
Suppliers and Packaging for NDA: 022013
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OLUX E clobetasol propionate AEROSOL, FOAM;TOPICAL 022013 NDA AUTHORIZED GENERIC Mylan Pharmaceuticals Inc. 0378-8055 0378-8055-01 1 CAN in 1 CARTON (0378-8055-01) > 100 g in 1 CAN
OLUX E clobetasol propionate AEROSOL, FOAM;TOPICAL 022013 NDA AUTHORIZED GENERIC Mylan Pharmaceuticals Inc. 0378-8055 0378-8055-50 1 CAN in 1 CARTON (0378-8055-50) > 50 g in 1 CAN
Paragraph IV (Patent) Challenges for 022013
Tradename Dosage Ingredient NDA Submissiondate
OLUX E AEROSOL, FOAM;TOPICAL clobetasol propionate 022013 2010-02-25

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, FOAM;TOPICALStrength0.05%
Approval Date:Jan 12, 2007TE:AB2RLD:Yes
Patent:  Start TrialPatent Expiration:Sep 8, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Sep 8, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Nov 5, 2028Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF CORTICOSTEROID-RESPONSIVE DERMATOSES

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Serving leading biopharmaceutical companies globally:

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