Teva Pharmaceutical Industries Ltd. has settled patent litigation with GlaxoSmithKline relating to lamotrigine, the generic version of GlaxoSmithKline's Lamictal.
The terms of the settlement, which remain subjected to government review, provide that Teva may, under an exclusive royalty-bearing license from GSK and on a date not later than June 2005, distribute in the United States a generic version of lamotrigine chewable tablets (5 mg and 25 mg). In addition, Teva was granted the exclusive right to manufacture and sell its own generic version of lamotrigine tablets (25mg, 100 mg, 150 mg, and 200 mg) in the United States with an expected launch date in 2008. Additional terms of the settlement agreement were not disclosed, a Teva release said.
GlaxoSmithKline's Lamictal, which is indicated for the treatment of Bipolar Disorder and Epilepsy, had US sales of approximately $47 million in 2004 for the chewable tablets, and approximately $825 million in 2004 for the tablets, according to IMS.