Barr Laboratories, Inc a subsidiary of Barr Pharmaceuticals, Inc. has announced the dismissal of litigation related to its challenge of the patent protecting Eli Lilly and Company's Zyprexa Zydis (Olanzapine) Orally disintegrating tablets, 5mg, 10mg, 15mg and 20mg.
Following the Federal Circuit's affirmance of a decision by the trial court in favour of Eli Lilly on this patent in a suit against Zenith Goldline Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc. and Dr Reddy's Labs, Ltd., the company changed the patent certification for its Abbreviated New Drug Application (ANDA) that is currently pending at the US Food and Drug Administration (FDA) for Olanzapine orally disintegrating tablets from a paragraph IV to a paragraph III. The patent litigation dismissal is a result of the company's change to a paragraph III certification.
The patent listed in the orange book for Zyprexa Zydis expires on April 23, 2011 and the associated paediatric exclusivity expires on October 23, 2011. The company anticipates receiving final FDA approval upon expiration of the patent, and any related exclusivities that may be sought and granted.
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 and Company, the New Drug Application (NDA) holder. On December 1, 2004, Lilly Industries Limited and Eli Lilly and Company filed suit in US District Court, Southern District of Indiana to prevent Barr from proceeding with the commercialisation of its product.
The FDA issued a tentative approval for Barr's ANDA for Olanzapine Orally Disintegrating Tablets in November 2006. The Company notified FDA of the change in its certification in April 2007 and the litigation between the company and Lilly was subsequently dismissed.
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 $252 million for the twelve months ended March 2007, based on IMS sales data.