The injunction prohibits Mylan Pharmaceuticals and Dr Reddy's Laboratories from selling their proposed generic risperidone products in the US until the patent on Risperdal expires in 2007.
The ruling directs the FDA to change the effective date of Mylan's tentative approval to market its generic risperidone tablets to no earlier than the Risperdal patent expiration.
The patent infringement complaint was filed by Janssen in December 2003. 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 manufactured by Janssen LP a subsidiary of Johnson & Johnson.
Risperdal is indicated for the treatment of schizophrenia, bipolar disorder and for the treatment of irritability associated with autism.