FDAnews Drug Daily Bulletin

Par Pharmaceutical has won a court battle over a proposed generic of Ortho-McNeil-Janssen Pharmaceuticals’ Ultram extended-release (ER) that may permit it to market its formulation of the painkiller in the U.S. The company has tentative FDA approval of the 100- and 200-mg strengths of Ultram ER (tramadol HCl) and intends to review its options with respect to its ANDA, Par says in a statement. Judge Kent Jordan of the U.S. District Court for the District of Delaware ruled that the ’887 and ’430 patents owned by Purdue Pharma Products are invalid as obvious in light of prior art, according to court documents filed recently.
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