Avanafil Patent Expiration

Avanafil is Used for treating erectile dysfunction. It was first introduced by Metuchen Pharmaceuticals Llc in its drug Stendra on Apr 27, 2012. 2 different companies have introduced drugs containing Avanafil.


Avanafil Patents

Given below is the list of patents protecting Avanafil, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Stendra US6656935 Aromatic nitrogen-containing 6-membered cyclic compounds Apr 27, 2025 Metuchen Pharms
Stendra US7501409 Preparations for oral administration May 05, 2023

(Expired)

Metuchen Pharms



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 Avanafil's patents.

Given below is the list recent legal activities going on the following patents of Avanafil.

Activity Date Patent Number
Patent litigations
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)


Avanafil's Family Patents

Family Patents

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Avanafil Generic API Manufacturers

Several generic applications have been filed for Avanafil.

Given below is the list of companies who have filed for Avanafil generic, along with the locations of their manufacturing plants worldwide.


1. HETERO LABS LTD V

Hetero Labs Ltd Unit V has filed for 3 different strengths of generic version for Avanafil. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd V.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG

tablet Prescription ORAL AB Jun 14, 2024
100MG

tablet Prescription ORAL AB Jun 14, 2024
200MG

tablet Prescription ORAL AB Jun 14, 2024