Par wins on invalidity in Ultram ER litigation

WOODCLIFF LAKE, N.J. A generic drug maker has won a patent litigation for a narcotic-like pain reliever.

Par Pharmaceutical announced that the U.S. District Court for the District of Delaware has ruled in favor of Par in its challenge of Purdue's patents relating to extended-release tramadol, which are listed in the Orange Book for Ortho-McNeil's Ultram ER product.

Par earlier announced that it was seeking marketing approval for generic extended-release tramadol, and that it was the first-filed abbreviated new drug application with respect to the Ultram ER product.

Par currently has tentative approval on two of the three strengths (100 mg and 200 mg) of tramadol ER. Par intends to review its options with respect to its tramadol ER ANDA.