U.S. COURT OF APPEALS RULES IN FAVOR OF MYLAN IN OXYBUTYNIN PATENT LITIGATION

Mylan Laboratories Inc. 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.
Drug Newswire