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Betamethasone valerate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for betamethasone valerate?

Betamethasone valerate is the generic ingredient in eight branded drugs marketed by Schering, Mylan Pharms Inc, Perrigo, Roaco, Taro, G And W Labs Inc, Actavis Mid Atlantic, Sti Pharma Llc, Perrigo New York, Pharmaderm, Fougera, Savage Labs, Teva Pharms, and Pharmafair, and is included in twenty-nine NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has twenty-six patent family members in twenty countries.

There are sixty-six drug master file entries for betamethasone valerate. Sixteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: betamethasone valerate

Tradenames:8
Patents:2
Applicants:14
NDAs:29
Drug Master File Entries: see list66
Suppliers / Packagers: see list16
Bulk Api Vendors: see list28
Clinical Trials: see list40
Patent Applications: see list2,864
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:betamethasone valerate at DailyMed

Pharmacology for Ingredient: betamethasone valerate

Tentative approvals for BETAMETHASONE VALERATE

Applicant Application No. Form Dosage
► Subscribe► SubscribeFOAM;TOPICAL0.12%
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fougera
BETAMETHASONE VALERATE
betamethasone valerate
LOTION;TOPICAL018866-001Aug 31, 1983RXYesYes► Subscribe► Subscribe
Savage Labs
BETATREX
betamethasone valerate
CREAM;TOPICAL018862-001Aug 31, 1983DISCNNoNo► Subscribe► Subscribe
Taro
DERMABET
betamethasone valerate
CREAM;TOPICAL072041-001Jan 6, 1988RXNoNo► Subscribe► Subscribe
Schering
VALISONE
betamethasone valerate
CREAM;TOPICAL016322-002Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe
Teva Pharms
BETAMETHASONE VALERATE
betamethasone valerate
LOTION;TOPICAL071883-001Apr 22, 1988DISCNNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: betamethasone valerate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Pharms Inc
LUXIQ
betamethasone valerate
AEROSOL, FOAM;TOPICAL020934-001Feb 28, 19996,126,920► Subscribe
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Non-Orange Book Patents for Generic Ingredient: betamethasone valerate

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
6,126,920 Method of treating a skin disease with a corticosteroid-containing pharmaceutical composition► 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: betamethasone valerate

Country Document Number Estimated Expiration
Japan4557310► Subscribe
United Kingdom9504265► Subscribe
China1179720► Subscribe
Austria253367► Subscribe
Poland322088► 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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