On September 22, 2004, Ortho-McNeil filed a complaint in the US District Court alleging that Caraco’s filing of an ANDA seeking approval to market the generic version of the drug infringed Ortho-McNeil’s patent, which expires on September 6, 2011.
Ortho-McNeil sought an order from the court which, among other things, directed the FDA not to approve Caraco’s ANDA any earlier than the claimed expiration date. However, the court has now granted Caraco’s motion for non-infringement. Ortho-McNeil still has the option to appeal the decision.
“We are pleased that summary judgment was granted in our favor and that the decision was handled swiftly,” said Daniel Movens, CEO. “We are currently awaiting final FDA approval of Tramadol with Acetaminophen, our generic version of Ultracet, in order to market this product,” he added.