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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
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Generated: June 27, 2017

DrugPatentWatch Database Preview

Clobetasol propionate - Generic Drug Details

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What are the generic sources for clobetasol propionate and what is the scope of clobetasol propionate freedom to operate?

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

Clobetasol propionate has one hundred and three patent family members in twenty-six countries.

There are thirteen drug master file entries for clobetasol propionate. Thirty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: clobetasol propionate

Tradenames:10
Patents:12
Applicants:21
NDAs:50
Drug Master File Entries: see list13
Suppliers / Packagers: see list31
Bulk Api Vendors: see list40
Clinical Trials: see list347
Patent Applications: see list5,341
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:clobetasol propionate at DailyMed

Pharmacology for Ingredient: clobetasol propionate

Tentative approvals for CLOBETASOL PROPIONATE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe0.05%SPRAY;TOPICAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Taro
CLOBETASOL PROPIONATE
clobetasol propionate
LOTION;TOPICAL200302-001Jul 2, 2012ABRXNoNo► Subscribe► Subscribe
Galderma Labs
CLOBEX
clobetasol propionate
SHAMPOO;TOPICAL021644-001Feb 5, 2004ABRXYesYes8,066,976► SubscribeY ► Subscribe
Actavis Mid Atlantic
CLOBETASOL PROPIONATE
clobetasol propionate
SHAMPOO;TOPICAL078854-001Jun 7, 2011ABRXNoNo► Subscribe► Subscribe
Fougera Pharms
CLOBETASOL PROPIONATE
clobetasol propionate
SOLUTION;TOPICAL075391-001Feb 8, 1999ATRXNoNo► Subscribe► Subscribe
Glenmark Pharms
CLOBETASOL PROPIONATE
clobetasol propionate
OINTMENT;TOPICAL208933-001Mar 20, 2017ABRXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: clobetasol propionate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fougera Pharms
TEMOVATE
clobetasol propionate
SOLUTION;TOPICAL019966-001Feb 22, 19903,721,687► Subscribe
Fougera Pharms
TEMOVATE
clobetasol propionate
CREAM;TOPICAL019322-001Dec 27, 19853,721,687► Subscribe
Mylan Pharms Inc
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
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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
5,886,038 Composition and method for treatment of psoriasis► Subscribe
8,263,580Vitamin formulation► Subscribe
8,629,128Vitamin formulation► Subscribe
8,449,867Microemulsion and sub-micron emulsion process and compositions► Subscribe
8,298,515Vitamin formulation► 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
Spain2200137► Subscribe
Canada2578594► Subscribe
South Africa9708353► Subscribe
Argentina019321► Subscribe
Japan4603164► 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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Serving 500+ biopharmaceutical companies globally:

Medtronic
Johnson and Johnson
Chubb
Mallinckrodt
Accenture
Colorcon
UBS
Cantor Fitzgerald
US Department of Justice
Julphar

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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