As the first company to file an abbreviated new drug application (ANDA) containing a Paragraph IV certification for this product, Teva said that it has been awarded a 180-day period of marketing exclusivity.
The approval follows an April 11, 2008 order by the US District Court for the District of Columbia granting a request of the company’s subsidiary, Teva Pharmaceuticals USA, that the FDA relist in the Orange Book the US patent of the company and grant Teva 180-day exclusivity for its Risperidone tablets. The FDA has appealed this decision and a hearing has been scheduled for September 12, 2008.