The United States Food and Drug Administration (FDA) has granted final approval to Watson Pharmaceuticals' Abbreviated New Drug Application (ANDA) for lidocaine topical patch five per cent, 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 five per cent product on September 15, 2013.
For the twelve months ending June 30, 2012, Lidoderm had total US sales of approximately $1.2 billion according to IMS Health data.
Watson Pharmaceuticals, Inc. is an integrated global specialty pharmaceutical company and is engaged in the development, manufacturing, marketing and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology and Women's Health.