Stendra is a drug owned by Metuchen Pharmaceuticals Llc. It is protected by 2 US drug patents filed in 2013. Out of these, 1 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 18, 2025. Details of Stendra's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US6656935 | Aromatic nitrogen-containing 6-membered cyclic compounds |
Apr, 2025
(8 months from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7501409 | Preparations for oral administration |
May, 2023
(1 year, 2 months 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 Stendra's patents.
Latest Legal Activities on Stendra's Patents
Given below is the list of recent legal activities going on the following patents of Stendra.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 27 Aug, 2020 | US7501409 (Litigated) |
| Patent Term Extension Certificate | 18 Mar, 2016 | US6656935 (Litigated) |
| Notice of Final Determination -Eligible | 18 Nov, 2015 | US6656935 (Litigated) |
| FDA Final Eligibility Letter | 21 Jan, 2015 | US6656935 (Litigated) |
| transaction for FDA Determination of Regulatory Review Period | 10 Jun, 2014 | US6656935 (Litigated) |
| transaction for FDA Determination of Regulatory Review Period | 09 May, 2014 | US6656935 (Litigated) |
| Second letter to regulating agency to determine regulatory review period | 19 Mar, 2014 | US6656935 (Litigated) |
| Letter from FDA or Dept of Agriculture re PTE application | 13 Feb, 2013 | US6656935 (Litigated) |
| Initial letter Re: PTE Application to regulating agency | 28 Sep, 2012 | US6656935 (Litigated) |
| Patent Term Extension Application under 35 USC 156 Filed | 18 Jun, 2012 | US6656935 (Litigated) |
FDA has granted several exclusivities to Stendra. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Stendra, 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 Stendra.
Exclusivity Information
Stendra holds 3 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Stendra's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Apr 27, 2017 |
| New Dosing Schedule(D-140) | Sep 17, 2017 |
| M(M-282) | Oct 18, 2025 |
US patents provide insights into the exclusivity only within the United States, but Stendra 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 Stendra's family patents as well as insights into ongoing legal events on those patents.
Stendra's family patents
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Generic Launch
Generic Release Date:
Stendra's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 18, 2025 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Stendra Generics:
Avanafil is the generic name for the brand Stendra. 1 company has already filed for the generic of Stendra. Check out the entire list of companies who have already received approval for Stendra's generic
How can I launch a generic of Stendra before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Stendra's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Stendra'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 Stendra -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 50 mg, 100 mg and 200 mg | 27 Apr, 2016 | 1 | 27 Apr, 2025 |
About Stendra
Stendra is a drug owned by Metuchen Pharmaceuticals Llc. It is used for treating erectile dysfunction. Stendra uses Avanafil as an active ingredient. Stendra was launched by Metuchen Pharms in 2012.
Market Authorisation Date:
Stendra was approved by FDA for market use on 27 April, 2012.
NCE-1 date:
NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Stendra is 27 April, 2012, its NCE-1 date is estimated to be 27 April, 2016
Active Ingredient:
Stendra uses Avanafil as the active ingredient. Check out other Drugs and Companies using Avanafil ingredient
Treatment:
Stendra is used for treating erectile dysfunction.
Dosage:
Stendra is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG | TABLET | Prescription | ORAL |
| 200MG | TABLET | Prescription | ORAL |
| 50MG | TABLET | Prescription | ORAL |