Generic Drug Opportunity Assessment - Avanafil (Stendra)

  • ID: 2727291
  • Report
  • Greystone Associates
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Stendra is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED). Stendra received FDA NDA approval in April 2012. In June 2013, the drug, which will be marketed outside the U.S. under the brand name Spedra, received EC approval to market the drug in the EU.

The drug is formulated as an oral tablet and is supplied in three dosages: 50 mg, 100 mg and 200 mg. Stendra is intended to be taken no more than once per day and based in clinical trial data has an onset of action of as little as 30 minutes. The drug has the same contraindications as those of competing PDE-5 inhibitors approved fro treating ED.

Vivus intends to market Stendra via third parties. An agreement for marketing in the U.S. was recently concluded and the company now anticipates market entry by the end of 2013.

The Market

For the treatment of ED, Stendra will compete with currently approved and marketed PDE5 inhibitors in the form of oral medications including Viagra (sildenafil citrate), marketed by Pfizer, Inc.; Cialis (tadalafil), marketed by Eli Lilly and Company; Levitra (vardenafil), comarketed by GlaxoSmithKline plc and Schering-Plough Corporation in the U.S.; and STAXYN (vardenafil in an oral disintegrating tablet, or ODT), co-marketed by GlaxoSmithKline plc and Merck & Co., Inc.

In addition to the above currently marketed PDE-5 inhibitors indicated for treating ED, WarnerChilcott plc has licensed the U.S. rights to udenafil, a PDE5 inhibitor from Dong-A Pharmaceutical.

ABOUT THIS REPORT

This report is part of the Generic Drug Opportunity Reports series. These reports are designed to allow Industry managers to understand and evaluate the market potential for selected branded drugs from the viewpoint of creating and refining FDA ANDA regulatory filings in pursuit of first-filer generic drug applications. Each report contains timely and insightful data and information on drugs that have been approved by the FDA under existing New Drug Applications (NDA), and which have one or more Orange Book listed patents with patent expiration dates that fall in 2016 or beyond, providing interested market participants with a time window to prepare and submit an ANDA filing.

Each Generic Market Opportunity Assessment includes data and analysis on key strategic and tactical factors designed to provide generic drug managers with decision support tools in the form of specific and comprehensive information and data.
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Report Highlights

Stendra – The Brand
Avanafil – The Product
Avanafil – The Market
Avanafil – The Opportunity
Manufacturing and Sourcing
Stendra Patents and Exclusivity
Therapeutic Class P4 Certifications
Generic First-to-File Revenue Opportunity
Business Risk Assessment
First-to-File – Probabilistic Scenario
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