The U.S. Food and Drug Administration (FDA) has granted pediatric exclusivity for RISPERDAL? (risperidone), based on studies conducted in Bipolar 1 Disorder and schizophrenia. The patent is set to expire in December 2007, however, this grant will extend the period of exclusivity on risperidone through the end of June 2008.
RISPERDAL is approved in the U.S. to treat acute manic or mixed episodes of Bipolar I Disorder and for the treatment of schizophrenia in adults. It is marketed by Janssen, L.P.
In October 2006, RISPERDAL? was also approved for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods, in children and adolescents ages 5 to 16 years. That indication was the first time the FDA approved any medication for use in children and adolescents with autism.