TWi Pharmaceuticals, Inc. today announced that it has entered into a settlement agreement with Endo Pharmaceuticals Inc., Teikoku Seiyaku Co., Ltd. and Teikoku Pharma USA, Inc. to settle all outstanding patent litigation related to TWi's lidocaine topical patch 5% product. An Abbreviated New Drug Application (ANDA) for TWi's product is currently under review at the U.S. Food and Drug Administration (FDA). If approved, TWi's product would be a generic version of Endo's Lidoderm®.
The settlement agreement allows TWi to launch its generic Lidoderm® product on or after March 1, 2015, if the product is approved by the FDA. The agreement also provides for an earlier launch date under certain circumstances. Pursuant to the agreement, the litigation on this matter, currently pending in U.S. District Court for the District of Delaware, will be dismissed. Other terms of the settlement agreement were not disclosed.
The settlement agreement is subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice.
SOURCE TWi Pharmaceuticals, Inc.