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Last Updated: September 25, 2022

OLUX E Drug Patent Profile


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Which patents cover Olux E, and what generic alternatives are available?

Olux E is a drug marketed by Mylan and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-two patent family members in sixteen countries.

The generic ingredient in OLUX E is clobetasol propionate. There are fourteen drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Olux E

A generic version of OLUX E was approved as clobetasol propionate by COSETTE on February 16th, 1994.

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Paragraph IV (Patent) Challenges for OLUX E
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
OLUX E Emulsion Foam clobetasol propionate 0.05% 022013 1 2010-02-25

US Patents and Regulatory Information for OLUX E

OLUX E is protected by two US patents.

Patents protecting OLUX E

Microemulsion process and composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CORTICOSTEROID-RESPONSIVE DERMATOSES

Microemulsion and sub-micron emulsion process and compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CORTICOSTEROID-RESPONSIVE DERMATOSES

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan OLUX E clobetasol propionate AEROSOL, FOAM;TOPICAL 022013-001 Jan 12, 2007 AB2 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Mylan OLUX E clobetasol propionate AEROSOL, FOAM;TOPICAL 022013-001 Jan 12, 2007 AB2 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for OLUX E

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan OLUX E clobetasol propionate AEROSOL, FOAM;TOPICAL 022013-001 Jan 12, 2007 See Plans and Pricing See Plans and Pricing
Mylan OLUX E clobetasol propionate AEROSOL, FOAM;TOPICAL 022013-001 Jan 12, 2007 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for OLUX E

See the table below for patents covering OLUX E around the world.

Country Patent Number Title Estimated Expiration
Australia 2005279704 Microemulsion & sub-micron emulsion process & compositions See Plans and Pricing
Russian Federation 2381023 СПОСОБ ПОЛУЧЕНИЯ МИКРОЭМУЛЬСИЙ И СУБМИКРОННЫХ ЭМУЛЬСИЙ И КОМПОЗИЦИИ НА ИХ ОСНОВЕ (METHOD FOR MAKING MICROEMULSIONS AND SUBMICRON EMULSIONS AND BASED COMPOSITION) See Plans and Pricing
Spain 2299258 See Plans and Pricing
South Korea 101243526 See Plans and Pricing
Canada 2611147 PREPARATION VITAMINEE (VITAMIN FORMULATION) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Merck
Boehringer Ingelheim
Colorcon
Mallinckrodt
Dow
Johnson and Johnson

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.