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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
Novartis
Dow
UBS
Cerilliant
Julphar
Johnson and Johnson
Moodys
Cipla
Boehringer Ingelheim

Generated: August 17, 2017

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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 eleven 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-two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: clobetasol propionate

Tradenames:10
Patents:11
Applicants:21
NDAs:50
Drug Master File Entries: see list13
Suppliers / Packagers: see list32
Bulk Api Vendors: see list40
Clinical Trials: see list348
Patent Applications: see list5,524
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
Akorn
CLOBETASOL PROPIONATE
clobetasol propionate
SPRAY;TOPICAL207218-001Apr 28, 2017ATRXNoNo► Subscribe► Subscribe► Subscribe
Actavis Mid Atlantic
CLOBETASOL PROPIONATE
clobetasol propionate
OINTMENT;TOPICAL074128-001Aug 3, 1994DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
OLUX E
clobetasol propionate
AEROSOL, FOAM;TOPICAL022013-001Jan 12, 2007AB2RXYesYes► Subscribe► SubscribeY ► Subscribe
Ingenus Pharms Llc
CLOBETASOL PROPIONATE (EMOLLIENT)
clobetasol propionate
CREAM;TOPICAL075733-001Aug 22, 2001DISCNNoNo► Subscribe► Subscribe► Subscribe
Tolmar
CLOBETASOL PROPIONATE
clobetasol propionate
SOLUTION;TOPICAL076977-001Aug 5, 2005ATRXNoNo► Subscribe► 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
CREAM;TOPICAL019322-001Dec 27, 1985► Subscribe► Subscribe
Mylan Pharms Inc
OLUX
clobetasol propionate
AEROSOL, FOAM;TOPICAL021142-001May 26, 2000► Subscribe► Subscribe
Fougera Pharms
TEMOVATE
clobetasol propionate
OINTMENT;TOPICAL019323-001Dec 27, 1985► Subscribe► Subscribe
Fougera Pharms
TEMOVATE
clobetasol propionate
SOLUTION;TOPICAL019966-001Feb 22, 1990► Subscribe► 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
8,263,580Vitamin formulation► Subscribe
8,449,867Microemulsion and sub-micron emulsion process and compositions► Subscribe
5,886,038 Composition and method for treatment of psoriasis► Subscribe
8,629,128Vitamin formulation► Subscribe
9,492,384Microemulsion and sub-micron emulsion process and compositions► 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
Australia4151499► Subscribe
Poland198663► Subscribe
European Patent Office1695691► Subscribe
Germany69722546► Subscribe
Denmark1087747► 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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Cerilliant
Healthtrust
Fish and Richardson
AstraZeneca
UBS
Chinese Patent Office
Moodys
Citi
Novartis
Baxter

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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