Research and Markets (http://www.researchandmarkets.com/research/ghxlmt/generic_drug)
has announced the addition of the "Generic
Drug Opportunity Assessment - Avanafil (Stendra)" report to
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
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.
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.
For more information visit http://www.researchandmarkets.com/research/ghxlmt/generic_drug
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