Published on August 18, 2009 at 3:37 AM
Par Pharmaceutical Companies, Inc. today 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(R) ER product.
Par earlier announced that it had filed an 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. Par intends to review its options with respect to its tramadol ER ANDA.
www.parpharm.com