Par Pharma (PRX) Receives Final U.S. FDA Approval for Tramadol ER Doses

November 16, 2009 8:31 AM EST

Par Pharmaceutical Companies, Inc. (NYSE: PRX) today announced that it has received final approval from the U.S. 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 U.S. sales of the 100mg and 200mg strengths of Ultram ER are approximately $156 million, according to IMS 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 of Delaware 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.

Tramadol hydrochloride is a centrally acting synthetic analgesic in an extended release formulation. Tramadol hydrochloride ER tablets are indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.

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