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Pharmaceutical Business Intelligence

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CLOBEX Drug Profile

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Clobex is a drug marketed by Galderma Labs Lp and Galderma Labs and is included in three NDAs. It is available from five suppliers. There are seven patents protecting this drug and three Paragraph IV challenges.

This drug has fifty-seven patent family members in twenty-four countries.

The generic ingredient in CLOBEX is clobetasol propionate. There are thirteen drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.

Summary for Tradename: CLOBEX

Patents:7
Applicants:2
NDAs:3
Suppliers / Packagers: see list5
Drug Prices: :see details

Pharmacology for Tradename: CLOBEX

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Galderma Labs Lp
CLOBEX
clobetasol propionate
LOTION;TOPICAL021535-001Jul 24, 2003RXYes6,106,848► subscribe ► subscribe
Galderma Labs
CLOBEX
clobetasol propionate
SHAMPOO;TOPICAL021644-001Feb 5, 2004RXYes8,066,976► subscribeY ► subscribe
Galderma Labs
CLOBEX
clobetasol propionate
SHAMPOO;TOPICAL021644-001Feb 5, 2004RXYes7,700,081► subscribe ► subscribe
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Paragraph IV activity for: CLOBEX

Drugname Dosage Strength RLD Submissiondate
clobetasol propionateSpray0.05%Clobex9/29/2008
clobetasol propionateTopical Shampoo0.05%Clobex1/9/2008
clobetasol propionateLotion0.05%Clobex3/27/2006

Non-Orange Book Patents for Tradename: CLOBEX

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
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 Tradename: CLOBEX

Country Document Number Estimated Expiration
Spain2247805► subscribe
Brazil9702897► subscribe
South Africa9708353► 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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