Unimed Pharmaceuticals Inc., a subsidiary of Solvay Pharmaceuticals Inc. has settled its pending patent infringement litigation with Watson Pharmaceutical and Par Pharmaceutical Companies Inc. on a generic version of AndroGel, a replacement therapy in men with conditions associated with a deficiency or absence of endogenous testosterone.
Under the separate settlements, generic AndroGel may be marketed in 2015, almost five years before the AndroGel patent expires in 2020. Under terms of settlement agreement, Solvay has granted Watson a non-exclusive license to the U.S. Patents covering AndroGel and Watson would not commence marketing its generic version until August 31, 2015 or the date on which another generic product enter the U.S. market, whichever occurs first.
Watson, which earlier received final approval of its ANDA on January 27, 2006 and was awarded 180 days marketing exclusivity for its ANDA, has agreed to forfeit its 180-day marketing exclusivity. Additionally, Watson has agreed that Watson’s Specialty Products sales force will co-promote AndroGel to urologists in the U.S.
Further, Par has acquired all rights to the ANDA for AndroGel from Paddock Laboratories, and subsequently entered into a separate agreement with Solvay under which Par’s branded sales force will co-promote AndroGel for six years.
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