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Details for Generic Name: oxandrolone

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Oxandrolone is the generic ingredient in two branded drugs marketed by Gemini Labs 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 / Packaging: see list2
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)

Clinical Trials for: oxandrolone

Oxandrolone for the Treatment of Bone Marrow Aplasia in Fanconi Anemia
Status: Completed Condition: Fanconi Anemia

Oxandrolone Compared With Megestrol in Preventing Weight Loss in Patients Receiving Chemotherapy for Cancer
Status: Completed Condition: Unspecified Adult Solid Tumor, Protocol Specific; Weight Changes

Pilot Study of the Safety and Efficacy of Oxandrolone in the Prevention and Treatment of Malnutrition in Infants
Status: Recruiting Condition: Malnutrition

Bioavailability Study of Oxandrolone Tablets Under Fasting Conditions
Status: Completed Condition: To Determine the Bioequivalence Under Fasting Conditions

Pilot Study of Goal-Directed Iron Supplementation +/- Oxandrolone for Functional Iron Deficiency of Critical Illness
Status: Not yet recruiting Condition: Functional Iron Deficiency; Trauma; Anemia

Oxandrolone to Heal Pressure Ulcers
Status: Terminated Condition: Pressure Ulcer

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz
OXANDROLONE
oxandrolone
TABLET;ORAL076897-002Dec 1, 2006DISCNNo<disabled><disabled>
Gemini Labs Llc
OXANDRIN
oxandrolone
TABLET;ORAL013718-002Nov 5, 2001RXYes5,872,147<disabled> <disabled>
Gemini Labs Llc
OXANDRIN
oxandrolone
TABLET;ORAL013718-001Approved Prior to Jan 1, 1982RXNo5,872,147<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;ORAL013718-001Approved Prior to Jan 1, 19826,670,351<disabled>
Gemini Labs Llc
OXANDRIN
oxandrolone
TABLET;ORAL013718-002Nov 5, 20016,670,351<disabled>
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International Patent Family for Ingredient: oxandrolone

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

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 information. There is no warranty that the information contained herein is error free. 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.

Copyright 2002-2016 thinkBiotech LLC
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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