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Details for Generic Name: oxandrolone

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Oxandrolone is the generic ingredient in two branded drugs marketed by Crealta Pharms Llc, Par Pharm, Roxane, Sandoz, and Upsher Smith, 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. One supplier is listed for this compound.

Summary for Generic Name: oxandrolone

Tradenames:2
Patents:4
Applicants:5
NDAs:6
Drug Master File Entries: see list9
Suppliers: see list1
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
Roxane
OXANDROLONE
oxandrolone
TABLET;ORAL077249-002Jul 10, 2007DISCNNo<disabled><disabled>
Par Pharm
OXANDROLONE
oxandrolone
TABLET;ORAL077827-001Jun 22, 2007RXNo<disabled><disabled>
Crealta Pharms Llc
OXANDRIN
oxandrolone
TABLET;ORAL013718-002Nov 5, 2001RXYes5,872,147<disabled><disabled>
Sandoz
OXANDROLONE
oxandrolone
TABLET;ORAL076897-002Dec 1, 2006DISCNNo<disabled><disabled>
Upsher Smith
OXANDROLONE
oxandrolone
TABLET;ORAL076761-001Dec 1, 2006RXNo<disabled><disabled>
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International Patent Family for Ingredient: oxandrolone

Country Document Number Publication Date
World Intellectual Property Organization (WIPO)9408590Apr 28, 1994
Australia5445994May 09, 1994
Israel107328Jan 25, 1994
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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.

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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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