Sep 11 2006
Mylan Laboratories Inc. has 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.
Robert J. Coury, Mylan's Vice Chairman and Chief Executive Officer commented: "We are pleased with the appellate court's decision and expect to launch all three strengths of this product. Oxybutynin is the latest in a series of difficult to formulate products that Mylan over the many years has been able to successfully develop."
Mylan Laboratories Inc. is a leading pharmaceutical company with three principal subsidiaries: Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories Inc. Mylan develops, licenses, manufactures, markets and distributes an extensive line of generic and proprietary products.