PITTSBURGH, Sept. 7 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. (NYSE: MYL - News) today announced that the U.S. Court of Appeals for the Federal Circuit upheld a district court decision that Mylan's Oxybutynin products do not infringe a patent for DITROPAN XL® and that the patent was invalid. Mylan has received tentative approval and is currently awaiting final approval from the United States Food and Drug Administration (FDA) for its 5 and 10 mg strengths of Oxybutynin. Mylan is the first generic company to file Abbreviated New Drug Applications (ANDAs) for these two strengths, and will therefore be eligible for 180-days of market exclusivity upon commercial launch. The 5 and 10 mg strengths represent more than 80% of the approximately $380 million in U.S. sales during the 12-month period ended June 30, 2006, according to IMS. The Company also entered into exclusive supply agreements with Ortho-McNeil Pharmaceuticals, Inc. and Alza Corporation which would allow for Mylan to launch all three strengths of DITROPAN XL.
