The USFDA has approved Watson Laboratories' abbreviated new drug application (ANDA) for lidocaine topical patch 5%, the generic equivalent to Endo's Lidoderm.
Lidocaine is an amide-type local anesthetic agent and is suggested to stabilize neuronal membranes by inhibiting the ionic fluxes required for the initiation and conduction of impulses.
In order to settle all the outstanding patent litigation related to Watson's generic version of Lidoderm, the company had entered into an agreement with Endo Pharmaceuticals and Teikoku Seiyaku on 29 May 2012.
Up on the settlement of the agreement with Endo, Watson plans to launch the product in September of 2013 and believes that under Hatch Waxman rules, it will be entitled to 180 days of marketing exclusivity.
According to IMS Health data, Lidoderm had total US sales of approximately $1.2bn for the twelve months ending 30 June 2012.
