MYLAN PREVAILS IN OXYBUTYNIN PATENT CHALLENGE

Mylan Laboratories has cleared another legal hurdle in its quest to market a generic version of Johnson & Johnson's incontinence drug Ditropan XL with a court ruling favoring its challenge to the product's patent.

The U.S. Court of Appeals for the Federal Circuit ruled that Mylan's generic Ditropan XL (oxybutynin) does not infringe on the patent for the drug and that the patent is invalid, the company said Sept. 7. Mylan now awaits final approval from the FDA before it can launch the drug.

As the first company to file abbreviated new drug applications for the 5- and 10-mg dosages, Mylan will get 180 days of market exclusivity. The company has already entered into supply agreements with Ortho-McNeil Pharmaceutical and Alza that will allow it to successfully launch the drug.

Those two dosages represent more than 80 percent of U.S. sales of Ditropan XL, which were approximately $380 million in the 12-month period ending June 30.