Oxandrin is a drug owned by Savient Pharmaceuticals Inc. It is protected by 5 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 05, 2017. Details of Oxandrin's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US5872147 | Use of oxandrolone in the treatment of chronic obstructive pulmonary disease |
Dec, 2017
(7 years ago) |
Expired
|
| US6828313 | Use of oxandrolone in the treatment of burns and other wounds |
Dec, 2017
(7 years ago) |
Expired
|
| US6576659 | Use of oxandrolone in the treatment of burns an other wounds |
Dec, 2017
(7 years ago) |
Expired
|
| US6090799 | Method for ameliorating muscle weakness/wasting in a patient infected with human immunodeficiency virus-type 1 |
Jul, 2017
(7 years ago) |
Expired
|
| US6670351 | Method for ameliorating muscle weakness/wasting in a patient infected with human immunodeficiency virus-type 1 |
Oct, 2012
(12 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Oxandrin's patents.
Latest Legal Activities on Oxandrin's Patents
Given below is the list of recent legal activities going on the following patents of Oxandrin.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Correspondence Address Change Critical | 23 Dec, 2008 | US6828313 |
| Patent Issue Date Used in PTA Calculation Critical | 07 Dec, 2004 | US6828313 |
| Recordation of Patent Grant Mailed Critical | 07 Dec, 2004 | US6828313 |
| Issue Notification Mailed Critical | 18 Nov, 2004 | US6828313 |
| Dispatch to FDC | 27 Oct, 2004 | US6828313 |
| Reverse Issue Fee | 19 Oct, 2004 | US6828313 |
| Issue Fee Payment Received Critical | 19 Oct, 2004 | US6828313 |
| Issue Fee Payment Verified Critical | 19 Oct, 2004 | US6828313 |
| Mail Notice of Allowance Critical | 18 Oct, 2004 | US6828313 |
| Notice of Allowance Data Verification Completed Critical | 15 Oct, 2004 | US6828313 |
US patents provide insights into the exclusivity only within the United States, but Oxandrin is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Oxandrin's family patents as well as insights into ongoing legal events on those patents.
Oxandrin's Family Patents
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Generic Launch
Generic Release Date:
Oxandrin's generic launch date based on the expiry of its last outstanding patent is estimated to be Dec 05, 2017 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Oxandrin Generic API suppliers:
Oxandrolone is the generic name for the brand Oxandrin. 4 different companies have already filed for the generic of Oxandrin, with Par Pharm having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Oxandrin's generic
How can I launch a generic of Oxandrin before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Oxandrin's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Oxandrin's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Oxandrin -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 2.5 mg and 10 mg | 19 Jun, 2006 | 1 | 05 Dec, 2017 | Extinguished |
About Oxandrin
Oxandrin is a drug owned by Savient Pharmaceuticals Inc. It is used for promoting weight gain after weight loss in specific patient populations. Oxandrin uses Oxandrolone as an active ingredient. Oxandrin was launched by Savient Pharms in 1982.
Approval Date:
Oxandrin was approved by FDA for market use on 01 January, 1982.
Active Ingredient:
Oxandrin uses Oxandrolone as the active ingredient. Check out other Drugs and Companies using Oxandrolone ingredient
Treatment:
Oxandrin is used for promoting weight gain after weight loss in specific patient populations.
Dosage:
Oxandrin is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2.5MG | TABLET | Prescription | ORAL |
| 10MG | TABLET | Prescription | ORAL |