TAIPEI, April 23, 2014 /PRNewswire/ -- 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.
Lidoderm® is indicated for relief of pain associated with post-herpetic neuralgia. For the 12 months ended December 31, 2013, the product had total U.S. sales of approximately $1.2 billion, according to IMS health data.
Lidoderm® is a registered trademark of Hind Health Care, Inc.
About TWi Pharmaceuticals, Inc.
TWi Pharmaceuticals, Inc. is a leading specialty pharmaceutical company based in Taipei, Taiwan, focusing on the development of high barrier generic prescription products ranging from oral controlled release dosage form to novel drug delivery systems including the utilization of nanoparticles, transdermal, and polymeric oral delivery systems. Leveraging its internal research and development capabilities, together with operational flexibility, process development, manufacturing and regulatory expertise, TWi Pharmaceuticals concentrates on products and technologies that present significant barriers to entry or offer Paragraph IV first-to-file or first-to-market opportunities in the United States. For more information of TWi Pharmaceuticals, please visit www.twipharma.com.
Head of Investor Relations
SOURCE TWi Pharmaceuticals, Inc.