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Oxandrolone - Generic Drug Details

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Oxandrolone is the generic ingredient in two branded drugs marketed by Gemini Labs Llc, Par Pharm, Upsher Smith, Roxane, and Sandoz, and is included in six NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has three patent family members in three countries.

There are nine drug master file entries for oxandrolone. Four suppliers are listed for this compound.

Summary for Generic Name: oxandrolone

Tradenames:2
Patents:4
Applicants:5
NDAs:6
Drug Master File Entries: see list9
Suppliers / Packaging: see list4
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Clinical Trials for: oxandrolone

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Upsher Smith
OXANDROLONE
oxandrolone
TABLET;ORAL078033-001Mar 22, 2007RXNo<disabled><disabled>
Upsher Smith
OXANDROLONE
oxandrolone
TABLET;ORAL076761-001Dec 1, 2006RXNo<disabled><disabled>
Sandoz
OXANDROLONE
oxandrolone
TABLET;ORAL076897-002Dec 1, 2006DISCNNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: oxandrolone

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gemini Labs Llc
OXANDRIN
oxandrolone
TABLET;ORAL013718-002Nov 5, 20016,670,351<disabled>
Gemini Labs Llc
OXANDRIN
oxandrolone
TABLET;ORAL013718-001Approved Prior to Jan 1, 19826,670,351<disabled>
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Non-Orange Book Patents for Generic Ingredient: oxandrolone

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
8,053,425Use of oxandrolone in the treatment of burns and other wounds<disabled in preview>
6,670,351 Method for ameliorating muscle weakness/wasting in a patient infected with human immunodeficiency virus-type 1<disabled in preview>
8,026,274Use of oxandrolone in the treatment of burns and other wounds<disabled in preview>
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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: oxandrolone

Country Document Number Estimated Expiration
Israel107328<disabled in preview>
World Intellectual Property Organization (WIPO)9408590<disabled in preview>
Australia5445994<disabled in preview>
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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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