Focalin XR® is an extended-release formulation of dexmethylphenidate and is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 years and older. ADHD is one of the most common childhood disorders and can continue through adolescence and adulthood. Symptoms include difficulty staying focused and paying attention, difficulty controlling behavior, and hyperactivity (over-activity). According to Wolters Kluwer Health, sales of Focalin XR® in the U.S. were approximately US$564 million for the 12 months ending September 2011.

Our license and commercialization agreement for the development of generic Focalin XR® with Par Pharmaceutical was executed in November 2005 and expanded in August 2011 to include additional strengths of the product that were recently introduced into the market. In 2010, we entered into license agreements with the product’s innovator in conjunction with the settlements of the litigation concerning our generic FDA drug application for the for the 5, 10, 15 and 20mg strengths of dexmethylphenidate hydrochloride extended-release capsules. Under the terms of the agreement, and subject to FDA approval, we expect that our generic version of Focalin XR will be launched in the fourth quarter of 2012. We have a ten year profit-sharing agreement with Par from commercial launch of the product.