<p>On June 21, 2006, Belcher submitted its abbreviated new drug application filing with the FDA, and included a Paragraph IV certification under the Hatch-Waxman Act, certifying that Belcher believes its proposed generic version of Clarinex tablets do not infringe Schering's patents. <br /><br />The Hatch-Waxman Act provides for a 180 day period of exclusivity to one or more proposed generic manufacturers that are the first to file a new drug application with a Paragraph IV certification, and prevail in the litigation. <br /><br />Belcher believes that it is among the first to file, but is not able to confirm this. Belcher was one of multiple generic drug companies named as defendants in the action. According to the complaint, the other defendants are alleged to have filed their new drug applications on the same day as Belcher. <br /><br />According to Schering-Plough, US sales of Clarinex for 2005 were $325 million.</p>