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Clobetasol propionate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for clobetasol propionate?

Clobetasol propionate is the generic ingredient in ten branded drugs marketed by Perrigo Israel, Taro, Wockhardt, Fougera Pharms, Mylan Pharms Inc, Hi Tech Pharma, Actavis Mid Atlantic, Perrigo, G And W Labs Inc, Ingenus Pharms Llc, 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 forty-eight 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 suppliers are listed for this compound.

Summary for Generic Name: clobetasol propionate

Tradenames:10
Patents:12
Applicants:19
NDAs:48
Drug Master File Entries: see list13
Suppliers / Packagers: see list30
Bulk Api Vendors: see list40
Clinical Trials: see list123
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

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hi Tech Pharma
EMBELINE
clobetasol propionate
GEL;TOPICAL076141-001Apr 12, 2002RXNoNo► Subscribe► Subscribe
Fougera Pharms
TEMOVATE
clobetasol propionate
GEL;TOPICAL020337-001Apr 29, 1994DISCNYesNo► Subscribe► Subscribe
G And W Labs Inc
CLOBETASOL PROPIONATE
clobetasol propionate
OINTMENT;TOPICAL074089-001Feb 16, 1994RXNoNo► Subscribe► Subscribe
G And W Labs Inc
CLOBETASOL PROPIONATE
clobetasol propionate
CREAM;TOPICAL074139-001Aug 3, 1994RXNoNo► Subscribe► Subscribe
G And W Labs Inc
CLOBETASOL PROPIONATE
clobetasol propionate
SOLUTION;TOPICAL074331-001Dec 15, 1995RXNoNo► 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, 19853,721,687► Subscribe
Fougera Pharms
TEMOVATE
clobetasol propionate
OINTMENT;TOPICAL019323-001Dec 27, 19853,721,687► Subscribe
Fougera Pharms
TEMOVATE
clobetasol propionate
SOLUTION;TOPICAL019966-001Feb 22, 19903,721,687► Subscribe
Mylan Pharms Inc
OLUX
clobetasol propionate
AEROSOL, FOAM;TOPICAL021142-001May 26, 20006,126,920► 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
8,449,867Microemulsion and sub-micron emulsion process and compositions► Subscribe
8,298,515Vitamin formulation► Subscribe
5,886,038 Composition and method for treatment of psoriasis► Subscribe
9,492,384Microemulsion and sub-micron emulsion process and compositions► Subscribe
8,263,580Vitamin 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
Poland187891► Subscribe
Norway320483► Subscribe
European Patent Office1872776► Subscribe
Austria444054► Subscribe
Israel121769► 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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