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Research and Markets: Generic Drug Opportunity Assessment - Avanafil (Stendra)
[January 24, 2014]

Research and Markets: Generic Drug Opportunity Assessment - Avanafil (Stendra)

DUBLIN --(Business Wire)--

Research and Markets ( has announced the addition of the "Generic Drug Opportunity Assessment - Avanafil (Stendra)" report to their offering.

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 thoe 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.

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

For more information visit

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