Risperidone (Riosperdal): Teva Launched Generic (with 180 days exclusivity) and Patriot launched authorized generic

Teva Pharma announced the launch of generic version of Janssen's antipsychotic agent Risperdal(R) (Risperidone) Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg. Teva is first Para IV filer and after the expiry of the product patent on 29th June 2008, Teva became eligible to launch generic version of Risperidone. Teva got this exclusivity by successfully relisting a patent (US5158952) on Paliperidone in Orange book by decision from a district court in April, 2011, where court sided with Teva and directed FDA to relist the said patent. The USFDA has appealed against this decision and a hearing has been scheduled in September, 2008.
Innovator Janssen in a bid to affect sale of Teva’s generic formulation announced that it has launched an authorized generic version of Risperidone through Patriot Pharma. The brand products had annual sales of approximately $2.5 billion in the United States.