Barr Laboratories dropped the patent litigation after the trial court found in favor of Eli Lilly on the patent in a suit against Zenith Goldline Pharmaceuticals, Teva Pharmaceuticals USA and Dr Reddy's Labs.
As a result, Barr decided to change the patent certification for its abbreviated new drug application (ANDA) for olanzapine, the generic version of Zyprexa Zydis, which is currently awaiting FDA approval, from a paragraph IV to a paragraph III.
Barr said that the patent litigation dismissal is a result of the company's change to a paragraph III certification. A paragraph III certification states the date on which the patent will expire. If an ANDA contains a paragraph III certification, approval may be made effective on the date certified under paragraph III, while an application under paragraph IV states that the patent is invalid, not infringed or unenforceable.
Barr expects to receive FDA approval after the patent protecting Eli Lilly's anti-psychotic treatment expires. The patent expires on April 23, 2011 and the associated pediatric exclusivity expires on October 23, 2011.
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.
However, on notifying Eli Lilly of this approval, the company filed a lawsuit to prevent Barr from proceeding with the commercialization of its product.
Barr said that the FDA issued a tentative approval for its ANDA for olanzapine in November 2006. The company notified the FDA of the change in its certification in April 2007, and the litigation between the company and Eli Lilly was subsequently dismissed.