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Serving 500+ biopharmaceutical companies globally:

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Generated: September 20, 2017

DrugPatentWatch Database Preview

CLOBETASOL PROPIONATE - Generic Drug Details

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What are the generic drug sources for clobetasol propionate and what is the scope of clobetasol propionate patent protection?

Clobetasol propionate
is the generic ingredient in ten branded drugs marketed by Perrigo Israel, Taro, Ingenus Pharms Llc, Wockhardt, Fougera Pharms, Teligent Pharma Inc, Mylan Pharms Inc, Akorn, Hi Tech Pharma, Actavis Mid Atlantic, Perrigo Co, G And W Labs Inc, Glenmark Pharms, Galderma Labs Lp, Galderma Labs, Novel Labs Inc, Tolmar, Zydus Pharms Usa Inc, Teva Pharms Usa, Fougera Pharms Inc, and Paddock Llc, and is included in fifty-two 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-three 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:52
Drug Master File Entries: see list13
Suppliers / Packagers: see list33
Bulk Api Vendors: see list40
Clinical Trials: see list353
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
Actavis Mid Atlantic
CLOBETASOL PROPIONATE
clobetasol propionate
LOTION;TOPICAL078223-001Dec 4, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Hi Tech Pharma
CORMAX
clobetasol propionate
CREAM;TOPICAL074220-001May 16, 1997AB1RXNoYes► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
OLUX E
clobetasol propionate
AEROSOL, FOAM;TOPICAL022013-001Jan 12, 2007AB2RXYesYes► Subscribe► SubscribeY ► Subscribe
Novel Labs Inc
CLOBETASOL PROPIONATE
clobetasol propionate
SOLUTION;TOPICAL206075-001Nov 23, 2015ATRXNoNo► Subscribe► Subscribe► Subscribe
Hi Tech Pharma
EMBELINE
clobetasol propionate
GEL;TOPICAL076141-001Apr 12, 2002ABRXNoNo► Subscribe► Subscribe► Subscribe
Taro
CLOBETASOL PROPIONATE
clobetasol propionate
SOLUTION;TOPICAL075363-001Dec 29, 2000ATRXNoNo► Subscribe► Subscribe► Subscribe
Akorn
CLOBETASOL PROPIONATE
clobetasol propionate
SPRAY;TOPICAL207218-001Apr 28, 2017ATRXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms Usa
CLOBETASOL PROPIONATE
clobetasol propionate
CREAM;TOPICAL074087-001Feb 16, 1994DISCNNoNo► Subscribe► Subscribe► Subscribe
Fougera Pharms
TEMOVATE E
clobetasol propionate
CREAM;TOPICAL020340-001Jun 17, 1994DISCNYesNo► Subscribe► Subscribe► Subscribe
Fougera Pharms
TEMOVATE
clobetasol propionate
CREAM;TOPICAL019322-001Dec 27, 1985DISCNYesNo► 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
Fougera Pharms
TEMOVATE
clobetasol propionate
SOLUTION;TOPICAL019966-001Feb 22, 1990► 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
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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
9,492,384Microemulsion and sub-micron emulsion process and compositions► Subscribe
8,298,515Vitamin formulation► Subscribe
8,449,867Microemulsion 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
Japan4091257► Subscribe
Israel139940► Subscribe
World Intellectual Property Organization (WIPO)9965456► Subscribe
Japan2928205► Subscribe
Netherlands300225► Subscribe
South Africa9708353► Subscribe
World Intellectual Property Organization (WIPO)0015193► Subscribe
Hong Kong1110198► Subscribe
Australia760153► Subscribe
Spain2299258► 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:

Healthtrust
AstraZeneca
Queensland Health
Teva
Chubb
Julphar
Johnson and Johnson
UBS
Accenture
Novartis

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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