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OXANDRIN Drug Profile

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Oxandrin is a drug marketed by Gemini Labs Llc and is included in one NDA. 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. Four suppliers are listed for this compound. Additional details are available on the oxandrolone profile page.

Summary for Tradename: OXANDRIN

Patents:4
Applicants:1
NDAs:1

Clinical Trials for: OXANDRIN

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gemini Labs Llc
OXANDRIN
oxandrolone
TABLET;ORAL013718-001Approved Prior to Jan 1, 1982RXNo5,872,147<disabled> <disabled>
Gemini Labs Llc
OXANDRIN
oxandrolone
TABLET;ORAL013718-002Nov 5, 2001RXYes6,576,659<disabled> <disabled>
Gemini Labs Llc
OXANDRIN
oxandrolone
TABLET;ORAL013718-001Approved Prior to Jan 1, 1982RXNo6,828,313<disabled> <disabled>
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Expired Patents for Tradename: OXANDRIN

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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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Paragraph IV activity for: OXANDRIN

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

Premature patent expiration for: OXANDRIN

Expiration due to failure to pay maintenance fee

Patent Number Tradename Expiration Date
6,576,659
OXANDRIN
June 10, 2015

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
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>
8,026,274Use 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 Estimated Expiration
Israel107328<disabled in preview>
World Intellectual Property Organization (WIPO)9408590<disabled in preview>
Australia5445994<disabled in preview>
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