Par Pharmaceutical Receives Final Approval to Market Generic Ultram(R) ER
Mon, 11/16/2009 - 3:36am
Par PharmaceuticalCompanies, Inc. today announced that it has received finalapproval from the FDA for its Abbreviated NewDrug Application for the 100mg and 200mg strengths of tramadol ER.Ortho-McNeil sells extended-release tramadol tablets under the brand nameUltram ER. Par has been awarded 180 days of marketing exclusivity,commencing at launch, for being the first to file an ANDA containing aparagraph IV certification for the product. Annual U.S. sales of the 100mgand 200mg strengths of Ultram ER are approximately $156 million, according toIMS Health data. Par began shipping tramadol ER to the trade upon approval.In August, Par announced that the U.S. District Court for the District ofDelaware ruled in favor of Par in its challenge of Purdue's patents relatingto extended-release tramadol, which are listed in the Orange Book forOrtho-McNeil's Ultram ER product.