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Profile for Tradename: OXANDRIN

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Oxandrin is a drug marketed by Crealta Pharms Llc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has three patent family members in three countries.

The generic ingredient in OXANDRIN is oxandrolone. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the oxandrolone profile page.

Summary for Tradename: OXANDRIN

Patents:4
Applicants:1
NDAs:1
Suppliers: see list1

Clinical Trials for: OXANDRIN

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

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

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: Completed Condition: Malnutrition

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

The Use of Anabolic Steroids to Improve Function After Spinal Cord Injury
Status: Completed Condition: Spinal Cord Injury

Oxandrolone Compared With a Placebo on Growth Rate in Girls With Growth Hormone-Treated Turner's Syndrome
Status: Completed Condition: Turner's Syndrome

Study of Albuterol and Oxandrolone in Patients With Facioscapulohumeral Dystrophy (FSHD)
Status: Completed Condition: Muscular Dystrophies

Assessment of the Treatment of Severely Burned With Anabolic Agents on Clinical Outcomes, Recovery and Rehabilitation
Status: Recruiting Condition: Burns

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Crealta Pharms Llc
OXANDRIN
oxandrolone
TABLET;ORAL013718-002Nov 5, 2001RXYes5,872,147<disabled><disabled>
Crealta Pharms Llc
OXANDRIN
oxandrolone
TABLET;ORAL013718-001Approved Prior to Jan 1, 1982RXNo6,576,659<disabled><disabled>
Crealta Pharms Llc
OXANDRIN
oxandrolone
TABLET;ORAL013718-001Approved Prior to Jan 1, 1982RXNo5,872,147<disabled><disabled>
Crealta Pharms Llc
OXANDRIN
oxandrolone
TABLET;ORAL013718-001Approved Prior to Jan 1, 1982RXNo6,828,313<disabled><disabled>
Crealta Pharms Llc
OXANDRIN
oxandrolone
TABLET;ORAL013718-002Nov 5, 2001RXYes6,090,799<disabled><disabled>
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Paragraph IV activity for: OXANDRIN

Drugname Dosage Strength RLD Submissiondate
oxandroloneTablets2.5 mg and 10 mgOxandrin6/19/2006

Non-Orange Book Patents for Tradename: OXANDRIN

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
8,026,274Use 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>
8,053,425Use of oxandrolone in the treatment of burns and other wounds<disabled in preview>
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International Patent Family for Tradename: OXANDRIN

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