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news.Barr Pharmaceuticals has received tentative approval from the FDA for its generic version of Eli Lilly's Zyprexa Zydis for schizophrenia.
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The company anticipates receiving final approval following the expiration of the 30-month stay in April 2007.
The Zyprexa Zydis patent expires on April 23, 2011. Barr’s Abbreviated New Drug Application alleges that the listed patent is invalid and would not be infringed by Barr’s product.
Barr filed its new drug application for a generic Zyprexa Zydis product with the FDA in August 2004. Following receipt of the notice from the FDA, Barr notified Eli Lilly & Company of the filing. On December 1, 2004, Eli Lilly filed suit in a US District Court to prevent Barr from proceeding with the commercialization of its product.
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 twelve months ended September 2006, based on IMS sales data.
A tentative approval reflects FDA’s preliminary determination that a generic product satisfies the substantive requirements for approval but does not allow the applicant to market the generic drug product.