.

Flexible Flat-Rate Plans

Flat-rate pricing for predictable budgeting

Short-term plans for project- or client-based billing

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

OXANDRIN Drug Profile

« Back to Dashboard
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
Drug Prices: :see details

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, 1982RXNo5,872,147Dec 5, 2017
Gemini Labs Llc
OXANDRIN
oxandrolone
TABLET;ORAL013718-002Nov 5, 2001RXYes6,576,659Dec 5, 2017
Gemini Labs Llc
OXANDRIN
oxandrolone
TABLET;ORAL013718-001Approved Prior to Jan 1, 1982RXNo6,828,313Dec 5, 2017
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Patents for Tradename: OXANDRIN

These historical archives are available as an add-on to one-year subscriptions.
See the Signup Form for more information.

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>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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>
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Tradename: OXANDRIN

Country Document Number Estimated Expiration
Israel107328<disabled in preview>
Australia5445994<disabled in preview>
World Intellectual Property Organization (WIPO)9408590<disabled in preview>
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

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.

`abc