PAR PHARMACEUTICALS ANNOUNCES RULING ON ONDANESTRON HCL

Par Pharmaceutical announced that the U.S. District Court for the District of New Jersey has issued a summary judgment ruling that GlaxoSmithKline's U.S. Patent Nos. 5,578,628 and 4,753,789 for Zofran ODT (ondansetron HCl) Orally Disintegrating Tablets are valid, enforceable and infringed by Par's wholly-owned subsidiary, Kali Laboratories. Zofran ODT is used for the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, certain radiotherapies, and the prevention of postoperative nausea and/or vomiting. Annual U.S. sales of Zofran ODT are approximately $225 million. Kali intends to appeal the court's decision.

Kali filed an abbreviated new drug application (ANDA) containing a Pragraph IV certification with the FDA in September 2002 seeking marketing clearance for its generic version of Zofran ODT. In October 2002, Kali's ANDA was accepted for filing by the FDA. GlaxoSmithKline did not file suit against Kali on U.S. Patent Nos. 5,955,488 and 6,063,802, which expire in May 2016.