TITUSVILLE, N.J., Oct. 16 /PRNewswire/ -- Janssen, L.P. today announced that a U.S. District Court upheld the validity and enforceability of the RISPERDAL(R) (risperidone) patent. The injunction that was entered prohibits Mylan Pharmaceuticals, Inc. and Dr. Reddy’s Laboratories, Ltd. from selling their proposed generic risperidone products in the U.S. until the Janssen patent on RISPERDAL expires in 2007.
The ruling, issued by U.S. District Court Judge John C. Lifland in Newark, N.J. directs the U.S. Food and Drug Administration (FDA) to change the effective date of Mylan’s tentative approval to market its generic risperidone tablets to no earlier than the December 29, 2007 RISPERDAL patent expiration.
The patent infringement complaint was filed by Janssen in December 2003 and claimed that Mylan and Dr. Reddy’s generic products infringed the RISPERDAL patent -- a charge that Mylan and Dr. Reddy did not dispute at trial. Two additional suits against Dr. Reddy’s for its orally-disintegrating risperidone tablet, filed in February 2005 and November 2005, were consolidated in this trial.
The FDA first approved RISPERDAL in 1993. RISPERDAL is indicated for the treatment of schizophrenia in adults, the short-term treatment of bipolar mania in adults, and for the treatment of irritability associated with autistic disorder in children and adolescents. RISPERDAL is available as tablets and solution for oral administration, as well as orally- distintegrating tablets (M-tabs).
Janssen, L.P., based in Titusville, N.J., is the only large pharmaceutical company in the US dedicated solely to mental health. For more information about Janssen, L.P., visit http://www.janssen.com, and for more information on RISPERDAL, visit http://www.risperdal.com.
Janssen, L.P.
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