Barr filed an Abbreviated New Drug Application (ANDA) for Risperidone Orally Disintegrating Tablets, 0.5mg, 1mg & 2mg containing a paragraph IV certification with the U.S. Food & Drug Administration (FDA) in March 2005 and received notification of the application's acceptance for filing in August 2005. Following receipt of the notice from the FDA, Barr notified Janssen Pharmaceutica, the New Drug Application (NDA) holder and patent owner. On October 3, 2005, Janssen filed suit in the U.S. District Court of New Jersey
to prevent Barr from proceeding with the commercialization of its product. This action formally initiates the patent challenge process under the Hatch-Waxman Act.
Risperdal is indicated for the treatment of schizophrenia, and the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder. The product had annual sales of approximately $67 million for the twelve months ended August 2005, based on IMS sales data.