FDAnews Drug Daily Bulletin

Par Pharmaceutical and Johnson & Johnson (J&J) unit Ortho-McNeil have entered into a settlement agreement that resolves patent litigation related to Ultracet, the companies announced.

Under the terms of the settlement, Par agreed to stop selling its generic version of the pain reliever Nov. 15 and will pay Ortho-McNeil royalties on sales until then, the companies said. Par will also pay Ortho-McNeil royalties on sales from August 2006 to June 2007.

In addition, Par and its subsidiary Kali Laboratories acknowledged that the reissue patent for Ultracet (tramadol/acetaminophen) is valid and enforceable, and that they infringed on it by selling the generic in the U.S., Ortho-McNeil said.