Barr Pharmaceuticals Inc announced that Barr Laboratories Inc has received tentative approval from the US FDA for its generic version of GlaxoSmithKline's Zofran ODT (ondansetron) Orally Disintegrating Tablets, 4mg and 8mg. The Company anticipates receiving final approval and launching its generic product following the expiration of GlaxoSmithKline's patent on June 24, 2006 or following any additional applicable exclusivity.

Barr's Ondansetron orally disintegrating tablets are indicated for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy, certain radiotherapies, and the prevention of postoperative nausea and/or vomiting. Zofran ODT had annual sales of approximately $167 million, based on IMS data for the twelve months ended June 2004, an official release said.

Barr filed an Abbreviated New Drug Application (ANDA) for Ondansetron Orally Disintegrating Tablets, 4mg and 8mg in March 2003, and received notification of the application's acceptance for filing in April 2003. The ANDA contained a paragraph IV certification that two of the patents listed in the Orange Book for Ondansetron Orally Disintegrating Tablets, 4mg and 8mg tablets were invalid or would not be infringed by Barr's product. Following receipt of notice from FDA, Barr notified GlaxoSmithKline of its ANDA filing. GlaxoSmithKline failed to file suit against Barr within the 45-day period provided for by the Hatch-Waxman Act.

Barr's ANDA also contained a paragraph III certification on the three other patents protecting Zofran ODT, the last of which expires on June 24, 2006.