Barr Nixes Zyprexa Patent Challenge

U.S. generic firm Barr said Monday it has nixed its patent challenge to Eli Lilly’s Zyprexa, after Lilly racked up wins against other generic rivals.

Barr said it withdrew its challenge against Lilly’s patent covering Zyprexa Zydis orally disintegrating tablets in 5-mg, 10-mg, 15-mg and 20-mg strengths, after a federal circuit court upheld the same patent against a string of generic challengers including Zenith Goldline, Teva and Dr. Reddy’s Labs Ltd.

Barr said it now anticipates receiving final FDA approval for its generic version of Zyprexa upon the patent’s normal expiration in 2011.

The listed patent expires on April 23 of that year, with the associated pediatric exclusivity lapsing on October 23, 2011.

The company said it filed for approval of its generic copy in August 2004, and Lilly filed suit to protect the Zyprexa patent in December of that year. The Food and Drug Administration granted tentative approval to Barr’s generic drug in November 2006.

Zyprexa — used to treat schizophrenia and for short-term treatment of acute manic episodes associated with bipolar disorder — had annual sales of roughly $252 million for the 12 months ended March 2007, based on IMS data, Barr said.