Staxyn is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is protected by 3 US drug patents filed from 2013 to 2014. Out of these, 1 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 23, 2028. Details of Staxyn'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). | |||
| US8613950 | Pharmaceutical forms with improved pharmacokinetic properties |
Dec, 2028
(3 years from now) | Active |
| US6362178 | 2-phenyl substituted imidazotriazinones as phosphodiesterase inhibitors |
Oct, 2018
(6 years ago) |
Expired
|
| US7696206 | 2-phenyl substituted imidazotriazinones as phosphodiesterase inhibitors |
Oct, 2018
(6 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 Staxyn's patents.
Latest Legal Activities on Staxyn's Patents
Given below is the list of recent legal activities going on the following patents of Staxyn.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Jun, 2021 | US8613950 (Litigated) |
| Mail O.P. Petition Decision | 16 Jan, 2015 | US8613950 (Litigated) |
| Mail-Record a Petition Decision of Granted for Patent Term Adjustment after Issue | 13 Jan, 2015 | US8613950 (Litigated) |
| O.P. Petition Decision | 12 Jan, 2015 | US8613950 (Litigated) |
| Record a Petition Decision of Granted for Patent Term Adjustment after Issue | 12 Jan, 2015 | US8613950 (Litigated) |
| Adjustment of PTA Calculation by PTO | 07 Jan, 2015 | US8613950 (Litigated) |
| Petition Entered | 21 Feb, 2014 | US8613950 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 24 Dec, 2013 | US8613950 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 24 Dec, 2013 | US8613950 (Litigated) |
| Email Notification Critical | 05 Dec, 2013 | US8613950 (Litigated) |
FDA has granted several exclusivities to Staxyn. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Staxyn, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Staxyn.
Exclusivity Information
Staxyn holds 1 exclusivities. All of its exclusivities have expired in 2013. Details of Staxyn's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Jun 17, 2013 |
Several oppositions have been filed on Staxyn's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Staxyn's generic, the next section provides detailed information on ongoing and past EP oppositions related to Staxyn patents.
Staxyn's Oppositions Filed in EPO
Staxyn has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jan 11, 2013, by Generics [Uk] Limited. This opposition was filed on patent number EP06706994A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP06706994A | Jan, 2013 | Accord Healthcare Ltd | Opposition rejected |
| EP06706994A | Jan, 2013 | Generics [UK] Limited | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Staxyn 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 Staxyn's family patents as well as insights into ongoing legal events on those patents.
Staxyn's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Staxyn's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 23, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Staxyn Generic API suppliers:
Vardenafil Hydrochloride is the generic name for the brand Staxyn. 7 different companies have already filed for the generic of Staxyn, with Macleods Pharms Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Staxyn's generic
How can I launch a generic of Staxyn before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Staxyn's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Staxyn'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 Staxyn -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mg | 22 Dec, 2011 | 1 | 23 Apr, 2015 | 31 Oct, 2018 | Extinguished Eligible |
Alternative Brands for Staxyn
Staxyn which is used for treating erectile dysfunction., has several other brand drugs in the same treatment category and using the same active ingredient (Vardenafil Hydrochloride). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Vardenafil Hydrochloride. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Bayer Hlthcare |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Vardenafil Hydrochloride, Staxyn's active ingredient. Check the complete list of approved generic manufacturers for Staxyn
About Staxyn
Staxyn is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is used for treating erectile dysfunction. Staxyn uses Vardenafil Hydrochloride as an active ingredient. Staxyn was launched by Bayer Hlthcare in 2010.
Approval Date:
Staxyn was approved by FDA for market use on 17 June, 2010.
Active Ingredient:
Staxyn uses Vardenafil Hydrochloride as the active ingredient. Check out other Drugs and Companies using Vardenafil Hydrochloride ingredient
Treatment:
Staxyn is used for treating erectile dysfunction.
Dosage:
Staxyn is available in tablet, orally disintegrating form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING | Discontinued | ORAL |