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Generic Drug Opportunity Assessment : Avanafil (Stendra)

  • January 2014
  • Greystone Research Associates
Report ID: 1973866


Greystone Research has identified a branded drug that represents an attractive opportunity for generic drug companies. Details of our findings are contained in an insightful assessment.


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.

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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