Mylan: court upholds patent decision in favor of Oxybutynin products

By Lisa Kerner

Charlotte, N.C., Sept. 7 - Mylan Laboratories Inc. said the U.S. Court of Appeals for the Federal Circuit upheld a district court decision that the company's Oxybutynin products do not infringe a patent for Ditropan XL and that the patent was invalid.

The pharmaceutical company is awaiting final approval from the Food and Drug Administration for the 5 mg and 10 mg strengths of Oxybutynin.

Mylan said it is the first generic company to file Abbreviated New Drug Applications for both strengths, which represent roughly 80% of the approximately $380 million in U.S. sales during the 12-month period ended June 30.

Exclusive supply agreements with Ortho-McNeil Pharmaceuticals, Inc. and Alza Corp. would allow Pittsburgh-based Mylan to launch three strengths of Ditropan XL.

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