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Clobetasol propionate - Generic Drug Details

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Clobetasol propionate is the generic ingredient in ten branded drugs marketed by Perrigo Israel, Taro, Wockhardt, Fougera Pharms, Delcor Asset, Hi Tech Pharma, Actavis Mid Atlantic, Perrigo, G And W Labs Inc, Ingenus Pharms Llc, Galderma Labs Lp, Renaissance Pharma, Delcor Asset Corp, Galderma Labs, Novel Labs Inc, Tolmar, Teva Pharms Usa, Fougera, and Paddock Llc, and is included in forty-five NDAs. There are twelve patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and twenty-eight patent family members in twenty-nine countries.

There are thirteen drug master file entries for clobetasol propionate. Twenty-six suppliers are listed for this compound.

Summary for Generic Name: clobetasol propionate

Tradenames:10
Patents:12
Applicants:19
NDAs:45
Drug Master File Entries: see list13
Suppliers / Packaging: see list26
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: clobetasol propionate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
G And W Labs Inc
CLOBETASOL PROPIONATE
clobetasol propionate
CREAM;TOPICAL074139-001Aug 3, 1994RXNo► subscribe► subscribe
Delcor Asset
OLUX E
clobetasol propionate
AEROSOL, FOAM;TOPICAL022013-001Jan 12, 2007RXYes8,460,641► subscribeY ► subscribe
Delcor Asset Corp
OLUX
clobetasol propionate
AEROSOL, FOAM;TOPICAL021142-001May 26, 2000RXYes6,126,920► subscribe ► subscribe
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Expired Orange Book Patents for Generic Ingredient: clobetasol propionate

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Delcor Asset Corp
OLUX
clobetasol propionate
AEROSOL, FOAM;TOPICAL021142-001May 26, 20006,126,920► subscribe
Fougera Pharms
TEMOVATE
clobetasol propionate
OINTMENT;TOPICAL019323-001Dec 27, 19853,721,687► subscribe
Fougera Pharms
TEMOVATE
clobetasol propionate
CREAM;TOPICAL019322-001Dec 27, 19853,721,687► subscribe
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Non-Orange Book Patents for Generic Ingredient: clobetasol propionate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,629,128Vitamin formulation► subscribe
8,263,580Vitamin formulation► subscribe
5,886,038 Composition and method for treatment of psoriasis► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: clobetasol propionate

Country Document Number Estimated Expiration
New Zealand302727► subscribe
Argentina008637► subscribe
France2761600► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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 verifification 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.

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