Pediatric Exclusivity Granted on Risperdal

U.S. firm Janssen said Thursday it has won six months’ pediatric market exclusivity for doing pediatric studies of Risperdal.

The patent on the drug — indicated for bipolar 1 disorder and schizophrenia in adults — was set to expire in December, but the pediatric exclusivity extends the patent through June 2008, the company said.

Last October the Food and Drug Administration approved expanded labeling for the anti-psychotic drug 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.

The new indication marks the first time the FDA has approved any drug for use in autistic children and adolescents, Janssen said.