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Last Updated: December 1, 2023

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. Forty-six 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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CORTICOSTEROID-RESPONSIVE DERMATOSES

Microemulsion and sub-micron emulsion process and compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Mylan OLUX E clobetasol propionate AEROSOL, FOAM;TOPICAL 022013-001 Jan 12, 2007 AB2 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Mylan OLUX E clobetasol propionate AEROSOL, FOAM;TOPICAL 022013-001 Jan 12, 2007 ⤷  Try a Trial ⤷  Try a Trial
>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
World Intellectual Property Organization (WIPO) 0015193 ⤷  Try a Trial
European Patent Office 1112062 COMPOSITION DE MOUSSE (MOUSSE COMPOSITION) ⤷  Try a Trial
Taiwan 200624124 Micro emulsion and sub-micron emulsion process and composition ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Merck
Boehringer Ingelheim
Colorcon
Mallinckrodt
Dow
Johnson and Johnson

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