Teva, GlaxoSmithKline Settle Patent Litigation Over Lamictal

Teva Pharmaceutical has settled patent litigation with GlaxoSmithKline (GSK) that will enable it to market a generic version of GSK's Lamictal.

Under terms of the settlement, Teva will be allowed to distribute a generic version of Lamictal (lamotrigine) chewable tablets in the U.S. in 5- and 25-mg strengths. Although terms of the settlement are still subject to government review, Teva will be allowed to distribute the product in the U.S. beginning no later than June if the agreement is approved.

Additionally, the settlement grants Teva the right to manufacture and sell lamotrigine tablets in 25-, 100-, 150- and 200-mg strengths in the U.S. The intended launch date for this product is 2008, the company said.

Lamictal is indicated to treat bipolar disorder and epilepsy. GSK received approval for the drug as an add-on therapy for partial epileptic seizures in pediatric patients in January 2003. In June 2003, Lamictal became the first drug approved to treat bipolar disorder since the FDA approved lithium in the 1970s.

In 2004, GSK reported sales of $47 million for Lamictal chewable tablets and $825 million for nonchewable tablets.