Generic Lamictal® XR™
A sixth product candidate in our generics pipeline is lamotrigine extended-release tablets. It is a generic version of the marketed drug Lamictal® XR™. This product is currently the subject of an Abbreviated New Drug Application (ANDA) filing with the U.S. Food and Drug Administration (FDA) and is partnered with Mallinckrodt LLC ("Mallinckrodt"). In October 2016, the Company also announced it had entered into a license and commercial supply agreement with Mallinckrodt, by which the Company has granted Mallinckrodt an exclusive license to market, sell and distribute in the United States its ANDA for generic Lamictal® XR™ under a 10 year agreement.
Lamotrigine is an anticonvulsant drug used in the treatment of epilepsy. According to Symphony Health Solutions, U.S. sales of Lamictal XR™ were approximately US$516 million for the 12 months ending December 2016 (TRx MBS Dollars).