Watson Pharma (WPI) Confirms Labs Unit Sued by Endo Pharma (ENDO), Penwest Pharma (PENW) in Connection with ANDA for Oxymorphone ER Tablets
Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc., has been sued by Endo Pharmaceuticals Inc. (Nasdaq: ENDO) and Penwest Pharmaceuticals Co. (Nasdaq: PENW) in connection with the filing of Watson's Abbreviated New Drug Application for Oxymorphone Hydrochloride Extended-Release Tablets, 40mg. Watson's Oxymorphone Hydrochloride Extended-Release Tablets product is a generic version of Endo's Opana® ER which is indicated for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time. Opana® ER had approximately $245 million in brand sales for the twelve months ending December 31, 2009, according to IMS Health.
On January 19, 2010, pursuant to the Hatch-Waxman Act, Watson notified Endo and Penwest that its ANDA contained a paragraph IV certification asserting that U.S. Patent Nos. 5,662,933, 5,958,456, and 7,276,250, which are listed in the Orange Book for Opana® ER, are invalid, unenforceable and/or not infringed.
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