WOODCLIFF LAKE, N.J. -- Barr Pharmaceuticals, Inc. announced that its subsidiary, Barr Laboratories, Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of Eli Lilly and Company's ZYPREXA(R) Zydis(R) (Olanzapine) Orally Disintegrating Tablets, 5mg, 10mg, 15mg and 20mg. 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 on April 23, 2011. Barr's Abbreviated New Drug Application (ANDA) alleges that the Orange Book listed patent is invalid, unenforceable and/or would not be infringed by Barr's product.
Barr filed its ANDA containing a paragraph IV certification for a generic ZYPREXA Zydis product with the FDA in August 2004, and received notification of the application's acceptance for filing in September 2004. Following receipt of the notice from the FDA, Barr notified Lilly Industries Limited, the patent owner, and Eli Lilly & Company, the New Drug Application (NDA) holder. On December 1, 2004, Lilly Industries Limited and Eli Lilly & Company filed suit in U.S. District Court, 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 (olanzapine) 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 twelve months ended September 2006, based on IMS sales data.
The big disadvantage of olanzapine is weight gain.
Barr Pharmaceuticals is down 42 cents today.
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My issue is Zyprexa which is only FDA approved for schizophrenia (.5-1% of pop) and some bipolar (2% pop) and then an even smaller percentage of theses two groups.
So how does Zyprexa get to be the 7th largest drug sale in the world?
Eli Lilly is in deep trouble for using their drug reps to 'encourage' doctors to write zyprexa for non-FDA approved 'off label' uses.
The drug causes increased diabetes risk,and medicare picks up all the expensive fallout.There are now 7 states (and counting) going after Lilly for fraud and restitution.
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Daniel Haszard
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