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Thursday, March 14, 2013 11:30:36 AM
Competition in the U.S. testosterone replacement market includes Abbvie’s Androgel® and Androgel® 1.62%, Lilly’s Axiron®, Endo Pharmaceuticals’ Fortesta® and Delatestryl®, Pfizer’s Depo®-Testosterone, Actavis’ Androderm®, Auxillium’s Testim®, Actient’s Striant® and Testopel® and several generic testosterone in oil products sold by Actavis, Sandoz, Mylan, Bedford Labs, Teva and others. In addition, at least three additional treatments for low testosterone levels are in development. Endo Pharmaceuticals has also filed for U.S. FDA approval of testosterone undecanoate injection, Aveed™. Endo licensed testosterone undecanoate injection from Bayer, which markets the product as Nebido® in Europe and elsewhere. Clarus Labs is developing an oral formulation of testosterone undecanoate, CLR-610, announcing positive Phase III clinical study results in September 2012. Trimel Pharmaceuticals is developing an intra-nasal testosterone formulation, CompleoTRT™, announcing positive Phase III clinical study results in December 2012.
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