Watson settles ORTHO TRI-CYCLEN LO patent litigation with Janssen

Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that its subsidiary, Watson Laboratories, Inc., has reached a settlement with Janssen Pharmaceuticals, Inc. (formerly Ortho-McNeil-Janssen Pharmaceuticals, Inc.) on outstanding patent litigation related to Watson's generic version of Janssen's ORTHO TRI-CYCLEN® LO (norgestimate/ethinyl estradiol) tablets.  Janssen filed its lawsuit on October 16, 2008 in the United States District Court for the District of New Jersey following Watson's filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its product prior to the expiration of U.S. Patent No. 6,241,815.

As part of the settlement, the parties have entered into a supply agreement whereby Janssen will manufacture and supply Watson with an authorized generic version of ORTHO TRI-CYCLEN® LO.  Watson will have the right to market and distribute the authorized generic on December 31, 2015, or earlier under certain circumstances. Other details of the settlement were not disclosed.

ORTHO TRI-CYCLEN® LO tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.