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Serving 500+ biopharmaceutical companies globally:

Queensland Health
Teva
Federal Trade Commission
Medtronic
Chinese Patent Office
Colorcon
Cipla
Fuji
Citi
US Army

Generated: August 21, 2017

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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, Upsher-smith Labs, Roxane, and Sandoz, 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 nine drug master file entries for oxandrolone. Three suppliers are listed for this compound.

Summary for Generic Name: oxandrolone

Tradenames:2
Patents:4
Applicants:5
NDAs:6
Drug Master File Entries: see list9
Suppliers / Packagers: see list3
Bulk Api Vendors: see list30
Clinical Trials: see list18
Patent Applications: see list1,985
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:oxandrolone at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roxane
OXANDROLONE
oxandrolone
TABLET;ORAL077249-001Jul 10, 2007DISCNNoNo► Subscribe► Subscribe► Subscribe
Gemini Labs Llc
OXANDRIN
oxandrolone
TABLET;ORAL013718-002Nov 5, 2001ABRXYesYes► Subscribe► Subscribe ► Subscribe
Gemini Labs Llc
OXANDRIN
oxandrolone
TABLET;ORAL013718-002Nov 5, 2001ABRXYesYes► Subscribe► Subscribe ► Subscribe
Gemini Labs Llc
OXANDRIN
oxandrolone
TABLET;ORAL013718-001Approved Prior to Jan 1, 1982ABRXYesNo► Subscribe► Subscribe ► Subscribe
Gemini Labs Llc
OXANDRIN
oxandrolone
TABLET;ORAL013718-002Nov 5, 2001ABRXYesYes► Subscribe► Subscribe ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: oxandrolone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gemini Labs Llc
OXANDRIN
oxandrolone
TABLET;ORAL013718-002Nov 5, 2001► Subscribe► Subscribe
Gemini Labs Llc
OXANDRIN
oxandrolone
TABLET;ORAL013718-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Gemini Labs Llc
OXANDRIN
oxandrolone
TABLET;ORAL013718-002Nov 5, 2001► Subscribe► Subscribe
Gemini Labs Llc
OXANDRIN
oxandrolone
TABLET;ORAL013718-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
8,026,274Use of oxandrolone in the treatment of burns and other wounds► Subscribe
6,670,351 Method for ameliorating muscle weakness/wasting in a patient infected with human immunodeficiency virus-type 1► Subscribe
8,053,425Use of oxandrolone in the treatment of burns and other wounds► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: oxandrolone

Country Document Number Estimated Expiration
Australia5445994► Subscribe
World Intellectual Property Organization (WIPO)9408590► Subscribe
Israel107328► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
Cantor Fitzgerald
McKesson
Baxter
Julphar
Federal Trade Commission
Merck
Daiichi Sankyo
Covington
Teva

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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