Sun Pharma settles litigation with Orion over generic Stalevo, Comtan ANDAs

Jun 22 2010

Sun Pharmaceutical Industries Ltd. announced that together with its affiliates ("Sun Pharma") it has executed a settlement agreement with Orion stipulating a dismissal of the lawsuits filed in the United States against Sun Pharma regarding submission of Abbreviated New Drug Applications (ANDAs) for generic versions of Stalevo® and Comtan® tablets.

Under the terms of the settlement agreement, Sun Pharma will be able to launch generic versions of 25/100/200 mg and 37.5/150/200 mg strengths of Stalevo® tablets in the US on 1 April 2012. In addition to these strengths, Sun Pharma will be able to launch generic versions of other strengths of Stalevo® product on 2 October 2012 and generic versions of Comtan® product on 1 April 2013, unless certain conditions relating to launch are fulfilled even earlier. The parties have agreed that Orion will supply these generic product versions to Sun Pharma. Other terms of the settlement are confidential.

These agreements will be subject to review by the US Federal Trade Commission and the US Department of Justice.

SOURCE Sun Pharmaceutical Industries Ltd.

www.sunpharma.com