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Serving leading biopharmaceutical companies globally:

Julphar
Merck
Teva
Chubb
Boehringer Ingelheim
Colorcon
McKesson
AstraZeneca
US Department of Justice
Mallinckrodt

Generated: October 20, 2017

DrugPatentWatch Database Preview

OXANDRIN Drug Profile

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Which patents cover Oxandrin, and what generic Oxandrin 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 nine 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 Tradename: OXANDRIN

US Patents:4
Applicants:1
NDAs:1
Bulk Api Vendors: see list30
Clinical Trials: see list3
Patent Applications: see list1,321
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:OXANDRIN at DailyMed
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;ORAL013718-001Approved Prior to Jan 1, 1982ABRXYesNo► 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
Gemini Labs Llc
OXANDRIN
oxandrolone
TABLET;ORAL013718-001Approved Prior to Jan 1, 1982ABRXYesNo► 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
Gemini Labs Llc
OXANDRIN
oxandrolone
TABLET;ORAL013718-002Nov 5, 2001ABRXYesYes► Subscribe► Subscribe ► Subscribe
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Expired Patents for Tradename: OXANDRIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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
Gemini Labs Llc
OXANDRIN
oxandrolone
TABLET;ORAL013718-002Nov 5, 2001► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges 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
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
8,026,274Use 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 Tradename: OXANDRIN

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 leading biopharmaceutical companies globally:

Accenture
Covington
Dow
Medtronic
Queensland Health
Cerilliant
Colorcon
Express Scripts
Cantor Fitzgerald
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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