The U.S. Court of Appeals for the Federal Circuit has favored Mylan Laboratories, Inc. (NYSE: MYL) by upholding a district court decision stating that Mylan's Oxybutynin products do not infringe a patent for Ortho-McNeil Pharmaceutical, Inc.’s DITROPAN XL® and that the patent was invalid.
Meanwhile, Mylan has already been granted USFDA tentative approval and is currently awaiting final approval for Oxybutynin 5 and 10 mg strengths.
Mylan being the first generic company to file Abbreviated New Drug Applications (ANDAs) for these two strengths of Oxybutynin is eligible for 180-days of market exclusivity upon commercial launch.
According to Robert J. Coury, Mylan's Vice Chairman and Chief Executive Officer:
"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."
Source: Mylan Laboratories, Inc.
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