PARSIPPANY, N.J. — Watson Pharmaceuticals Inc. has received approval from the Food and Drug Administration for its lidocaine topical patch 5%.
The company said Thursday that the product is the generic equivalent of Endo Pharmaceuticals Inc.’s Lidoderm.
Plans call for Watson to launch the Lidoderm generic product in September 2013 based on its settlement agreement with Endo. Watson added that it believes it will be entitled to 180 days of marketing exclusivity under Hatch-Waxman rules.
In late May, Watson announced it had entered into an agreement with Endo and Teikoku Seiyaku Co. Ltd. to settle all outstanding patent litigation related to Watson’s generic version of Lidoderm. Watson said the accord allows it to launch its lidocaine topical patch 5% product on Sept. 15, 2013.
Lidoderm had total U.S. sales of about $1.2 billion for the 12 months ended June 30, according to IMS Health figures cited by Watson.
