Watson’s Generic Lidoderm(R) Receives FDA Approval
August 25th, 2012 // 11:43 pm @ jmpickett
Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that its subsidiary, Watson Laboratories, Inc., has received final approval from the United States Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for lidocaine topical patch 5%, the generic equivalent to Endo’s Lidoderm®. Watson plans to launch the product in September of 2013 pursuant with its settlement agreement with Endo Pharmaceuticals Inc. and believes that under Hatch Waxman rules, it will be entitled to 180 days of marketing exclusivity.
On May 29, 2012, Watson announced it had entered into an agreement with Endo Pharmaceuticals Inc. and Teikoku Seiyaku Co., Ltd to settle all outstanding patent litigation related to Watson’s generic version of Lidoderm®. The agreement allows Watson to launch its lidocaine topical patch 5% product on September 15, 2013.
For the twelve months ending June 30, 2012, Lidoderm® had total U.S. sales of approximately $1.2 billion according to IMS Health data.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is an integrated global specialty pharmaceutical company. The Company is engaged in the development, manufacturing, marketing and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology and Women’s Health. The Company is also developing biosimilar products in Women’s Health and Oncology. Additionally, Watson distributes generic and branded pharmaceuticals through its Anda, Inc. distribution business. Watson has operations in many of the world’s established and growing international markets.
For press release and other company information, visit Watson Pharmaceuticals’ Web site at http://www.watson.com.
