Mylan settles Levetiracetam patent case

Mylan Inc. has announced that it and its subsidiary Mylan Pharmaceuticals Inc. have entered into an agreement to settle pending litigation with UCB Societe Anonyme and UCB Pharma Inc. (collectively, UCB) relating to Levetiracetam Tablets, 250mg, 500mg and 750mg, the generic version of UCB's Keppra.

Litigation between Mylan and UCB has been pending in the U.S. District Court for the Northern District of Georgia since March 2004. The lawsuit involved U.S. Patent No. 4,943,639, which expires on July 14, 2008.

Pursuant to the settlement, Mylan has the right to market the 250mg, 500mg and 750mg strengths of Levetiracetam Tablets in the United States on Nov. 1, 2008, provided that UCB obtains pediatric exclusivity for Keppra and Mylan's abbreviated new drug application (ANDA) obtains final approval from the Food and Drug Administration (FDA). If granted, pediatric exclusivity relating to the '639 patent would extend to Jan. 14, 2009. Mylan's entry into the market could come sooner than Nov. 1, 2008, if the FDA does not grant UCB pediatric exclusivity. Additional terms of the settlement are confidential, and the agreement is subject to review by the Department of Justice and the Federal Trade Commission.

Levetiracetam Tablets had U.S. sales of approximately $742 million for the 12 months ending June 30, 2007, for these three strengths.