U.S. court decision favors Teva in generic Temodar ANDA litigation

Jan 27 2010

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. District Court for the District of Delaware has issued a decision in its litigation over the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Schering-Plough’s brain tumor treatment Temodar® (temozolomide). The Court found that U.S. Patent No. 5,260,291 is not enforceable due to prosecution laches and inequitable conduct.

Teva’s tentatively approved ANDA to market temozolomide is currently pending final approval at the U.S. Food and Drug Administration (FDA). As the first company to file the ANDA that contained a paragraph IV certification for Temodar®, Teva is eligible to receive 180-day Hatch-Waxman statutory exclusivity to market this product.

Annual sales of the brand product were approximately $369 million in the United States based on IMS sales data.