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Watson Confirms Filing of FDA Application for Generic Lidoderm(R)

By Pharmaceutical Processing | January 19, 2010

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.

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