Par Pharmaceutical Companies, Inc has received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for the 100mg and 200mg strengths of tramadol ER. Ortho-McNeil sells extended-release tramadol tablets under the brand name Ultram ER. Par has been awarded 180 days of marketing exclusivity, commencing at launch, for being the first to file an ANDA containing a paragraph IV certification for the product. Annual US sales of the 100mg and 200mg strengths of Ultram ER are approximately US$ 156 million, according to IMS Health data. Par began shipping tramadol ER to the trade upon approval.
In August, Par announced that the US District Court for the District of Delaware ruled in favour 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 Pharma develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets.