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Serving leading biopharmaceutical companies globally:

Merck
Accenture
Harvard Business School
Fish and Richardson
Queensland Health
Baxter
Chinese Patent Office
US Army
Covington
Argus Health

Generated: January 19, 2018

DrugPatentWatch Database Preview

Oxandrolone - Generic Drug Details

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What are the generic sources for oxandrolone and what is the scope of oxandrolone freedom to operate?

Oxandrolone
is the generic ingredient in two branded drugs marketed by Gemini Labs Llc, Par Pharm, Roxane, Sandoz, and Upsher-smith Labs, 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.

Oxandrolone has three patent family members in three countries.

There are ten drug master file entries for oxandrolone. Three suppliers are listed for this compound.
Medical Subject Heading (MeSH) Categories for oxandrolone

US Patents and Regulatory Information for oxandrolone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz OXANDROLONE oxandrolone TABLET;ORAL 076897-001 Dec 1, 2006 DISCN No 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 013718-001 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
Sandoz OXANDROLONE oxandrolone TABLET;ORAL 076897-002 Dec 1, 2006 DISCN No 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
Roxane OXANDROLONE oxandrolone TABLET;ORAL 077249-002 Jul 10, 2007 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Par Pharm OXANDROLONE oxandrolone TABLET;ORAL 077827-002 Jun 22, 2007 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Roxane OXANDROLONE oxandrolone TABLET;ORAL 077249-001 Jul 10, 2007 DISCN No No ➤ 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 oxandrolone

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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Non-Orange Book US Patents for oxandrolone

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:

Teva
Farmers Insurance
Baxter
Boehringer Ingelheim
US Army
Healthtrust
Covington
Accenture
Federal Trade Commission

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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