Sep 28 2005
Mylan Laboratories today announced that the federal district court in the Northern District of West Virginia ruled in favor of Mylan in its Oxybutynin patent litigation with Alza Corporation, a subsidiary of Johnson & Johnson.
The court held that Mylan's unique delivery system did not infringe Alza's patent and further concluded that the patent was invalid as anticipated and obvious.
Mylan is the first generic company to file Abbreviated New Drug Applications (ANDAs) with the FDA for 5 mg and 10 mg Ditropan XL. The Company will be eligible for 180 days of market exclusivity upon final FDA approval, which has been requested. Ditropan XL had U.S. sales of approximately $440 million during the 12-month period ended June 30, 2005, with more than 80% of the volume in the 5 mg and 10 mg strengths, according to IMS.