BARR RECEIVES TENTATIVE APPROVAL FOR GENERIC ZYPREXA ZYDIS

Barr Pharmaceuticals announced that its subsidiary, Barr Laboratories, has received tentative approval from the FDA for its generic version of Eli Lilly's Zyprexa Zydis (Olanzapine) orally disintegrating tablets, 5, 10, 15 and 20 mg. The company anticipates receiving final approval following the expiration of the 30-month stay in April 2007.

The patent listed in the Orange Book for Zyprexa Zydis expires in April 2011, but Barr's abbreviated new drug application (ANDA) alleges that the patent is invalid, unenforceable and/or would not be infringed on by Barr's product.

Barr filed its ANDA containing a paragraph IV certification for generic Zyprexa Zydis in 2004. Eli Lilly then filed suit in U.S. District Court for the Southern District of Indiana to prevent Barr from proceeding with the commercialization of its product, formally initiating the patent challenge process under the Hatch-Waxman Act.

Zyprexa is indicated for the treatment of schizophrenia and for the short-term treatment of acute manic episodes associated with bipolar I disorder. The product had annual sales of approximately $246 million for the 12 months ending in September, Barr said, citing IMS Health.