Our lead generic product candidate is Dexmethylphenidate XR, a generic version of the marketed drug Focalin XR®, which is partnered with Par Pharmaceutical and is currently the subject of an Abbreviated New Drug Application (ANDA) filing with the U.S. Food and Drug Administration (FDA).
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). Focalin XR® had estimated sales of $350 million in 2008.
The license and commercialization agreement for the development of a generic Focalin XR with Par Pharmaceutical was executed in November 2005. Under the agreement we are responsible for some development costs and Par is responsible for certain costs including bioequivalence costs, API costs, and scale up / stability costs. Par is also responsible for costs associated litigation. We have a ten year profit-sharing agreement with Par from commercial launch of the product.