Par Pharmaceutical Wins On Invalidity In Ultram ER Litigation

Par Pharmaceutical has announced that the US 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 had filed an Abbreviated New Drug Application (ANDA) seeking marketing approval for generic extended-release tramadol, and that it was the first-filed ANDA with respect to the Ultram ER product.

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