Watson Laboratories files ANDA for Lidoderm

Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc., has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its lidocaine topical patch 8% prior to the expiration of U.S. Patent No. 5,827,529.  Watson's lidocaine topical patch 8% is a generic version of Endo's Lidoderm®.

On January 15, 2010, pursuant to the Hatch-Waxman Act, Watson notified Endo's partners Teikoku Seiyaku Co., Ltd. and Teikoku Pharma USA that its ANDA requesting approval from the FDA for a generic version of Lidoderm® contained a paragraph IV certification asserting that the Lidoderm® patent is invalid, unenforceable and/or not infringed.  Lidoderm® is indicated for relief of pain associated with post-herpetic neuralgia.  

SOURCE Watson Pharmaceuticals, Inc.