Barr drops challenge on Lilly's US Zyprexa patent

US generic drugmaker Barr Laboratories has dismissed litigation related to its challenge of the patent protecting US drug major Eli Lilly's blockbuster antispychotic Zyprexa (olanzapine) orally-disintegrating tablets, 5mg, 10mg, 15mg and 20mg.

Following the Federal Circuit's affirmation of a decision by the trial court in favor of Lilly in a suit against Zenith Goldline Pharmaceuticals, Teva Pharmaceuticals USA and Dr Reddy's Labs, Barr changed the patent certification for its Abbreviated New Drug Application currently pending at the US Food and Drug Administration for olanzapine tablets from a Paragraph IV to a Paragraph III, and the patent litigation dismissal is a result of this certification change.

On December 1, 2004, Lilly filed a suit in US District Court for Southern District of Indiana to prevent Barr from proceeding with the commercialization of its product. The FDA issued a tentative approval for Barr's ANDA in November 2006 and Barr notified the agency of the change in its certification in April 2007 and so the litigation between the two companies was subsequently dismissed.