Watson Pharmaceuticals, Inc. has
announced that its subsidiary, Watson Laboratories, Inc. has reached a
settlement with Endo Pharmaceuticals, Inc. on outstanding patent litigation
related to Endo’s Opana ER (Oxymorphone ER) product. Endo filed its lawsuit on
March 4, 2010, following Watson’s filing of an Abbreviated New Drug Application
(ANDA) with the FDA for seeking approval to market its product
in the 5, 7.5, 10, 15, 20, 30 and 40 mg dosage strengths.
Under terms of the settlement agreement, Endo has granted
Watson a royalty-free license to U.S. patents covering Opana ER.
Watson will have the right to launch its generic equivalent version of the
product on September 15, 2012, or earlier under certain circumstances. Other details
of the settlement were not disclosed.
