BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Cipla
Chubb
Express Scripts
Queensland Health
Covington
Harvard Business School
Argus Health
Cantor Fitzgerald
Medtronic

Generated: January 19, 2018

DrugPatentWatch Database Preview

OXANDRIN Drug Profile

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Which patents cover Oxandrin, and what generic alternatives are available?

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 ten drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the oxandrolone profile page.
Summary for OXANDRIN
Drug patent expirations by year for OXANDRIN
Medical Subject Heading (MeSH) Categories for OXANDRIN

US Patents and Regulatory Information for OXANDRIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gemini Labs Llc OXANDRIN oxandrolone TABLET;ORAL 013718-001 Approved Prior to Jan 1, 1982 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Gemini Labs Llc OXANDRIN oxandrolone TABLET;ORAL 013718-002 Nov 5, 2001 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Gemini Labs Llc OXANDRIN oxandrolone TABLET;ORAL 013718-001 Approved Prior to Jan 1, 1982 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Gemini Labs Llc OXANDRIN oxandrolone TABLET;ORAL 013718-002 Nov 5, 2001 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Gemini Labs Llc OXANDRIN oxandrolone TABLET;ORAL 013718-001 Approved Prior to Jan 1, 1982 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Gemini Labs Llc OXANDRIN oxandrolone TABLET;ORAL 013718-001 Approved Prior to Jan 1, 1982 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Gemini Labs Llc OXANDRIN oxandrolone TABLET;ORAL 013718-002 Nov 5, 2001 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Gemini Labs Llc OXANDRIN oxandrolone TABLET;ORAL 013718-002 Nov 5, 2001 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for OXANDRIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gemini Labs Llc OXANDRIN oxandrolone TABLET;ORAL 013718-001 Approved Prior to Jan 1, 1982 ➤ Subscribe ➤ Subscribe
Gemini Labs Llc OXANDRIN oxandrolone TABLET;ORAL 013718-001 Approved Prior to Jan 1, 1982 ➤ Subscribe ➤ Subscribe
Gemini Labs Llc OXANDRIN oxandrolone TABLET;ORAL 013718-002 Nov 5, 2001 ➤ Subscribe ➤ Subscribe
Gemini Labs Llc OXANDRIN oxandrolone TABLET;ORAL 013718-002 Nov 5, 2001 ➤ Subscribe ➤ Subscribe
Gemini Labs Llc OXANDRIN oxandrolone TABLET;ORAL 013718-002 Nov 5, 2001 ➤ Subscribe ➤ Subscribe
Gemini Labs Llc OXANDRIN oxandrolone TABLET;ORAL 013718-001 Approved Prior to Jan 1, 1982 ➤ Subscribe ➤ Subscribe
Gemini Labs Llc OXANDRIN oxandrolone TABLET;ORAL 013718-001 Approved Prior to Jan 1, 1982 ➤ Subscribe ➤ Subscribe
Gemini Labs Llc OXANDRIN oxandrolone TABLET;ORAL 013718-001 Approved Prior to Jan 1, 1982 ➤ Subscribe ➤ Subscribe
Gemini Labs Llc OXANDRIN oxandrolone TABLET;ORAL 013718-002 Nov 5, 2001 ➤ Subscribe ➤ Subscribe
Gemini Labs Llc OXANDRIN oxandrolone TABLET;ORAL 013718-002 Nov 5, 2001 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for OXANDRIN
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 2.5 mg and 10 mg ➤ Subscribe 6/19/2006

Non-Orange Book US Patents for 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 ➤ Subscribe
8,026,274 Use of oxandrolone in the treatment of burns and other wounds ➤ Subscribe
8,053,425 Use of oxandrolone in the treatment of burns and other wounds ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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Serving leading biopharmaceutical companies globally:

Merck
Julphar
Dow
Cantor Fitzgerald
Farmers Insurance
Harvard Business School
UBS
AstraZeneca
Cipla

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 data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. 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.

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