WatsonPharmaceuticals, Inc.,today confirmed that its subsidiary, Watson Laboratories, Inc., has filed anAbbreviated New Drug Application (ANDA) with the U.S. Food and DrugAdministration (FDA) seeking approval to market its lidocaine topical patch 8%prior to the expiration of U.S. Patent No. 5,827,529. Watson’s lidocainetopical patch 8% is a generic version of Endo’s Lidoderm. On January 15, 2010, pursuant to the Hatch-Waxman Act, Watson notifiedEndo’s partners Teikoku Seiyaku Co., Ltd. and Teikoku Pharma USA that its ANDArequesting approval from the FDA for a generic version of Lidoderm containeda paragraph IV certification asserting that the Lidoderm patent is invalid,unenforceable and/or not infringed. Lidoderm is indicated for relief of painassociated with post-herpetic neuralgia.
