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. Thirty-nine 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 16^th, 1994.

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Summary for OLUX E

International Patents:	22
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	80
Patent Applications:	4,524
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OLUX E
DailyMed Link:	OLUX E at DailyMed

Drug patent expirations by year for OLUX E

Anatomical Therapeutic Chemical (ATC) Classes for OLUX E

D07AD	Corticosteroids, very potent (group IV)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

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

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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
Mylan	OLUX E	clobetasol propionate	AEROSOL, FOAM;TOPICAL	022013-001	Jan 12, 2007		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Mylan	OLUX E	clobetasol propionate	AEROSOL, FOAM;TOPICAL	022013-001	Jan 12, 2007		DISCN	Yes	No	⤷ 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

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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.

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Country	Patent Number	Title	Estimated Expiration
New Zealand	508259	Mousse composition	⤷ Try a Trial
Canada	2333869	COMPOSITION DE MOUSSE (MOUSSE COMPOSITION)	⤷ Try a Trial
Spain	2429040		⤷ Try a Trial
Canada	2611147	PREPARATION VITAMINEE (VITAMIN FORMULATION)	⤷ Try a Trial
Spain	2431330		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Summary for OLUX E

Anatomical Therapeutic Chemical (ATC) Classes for OLUX E

Paragraph IV (Patent) Challenges for OLUX E

Patents protecting OLUX E

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