The terms of the settlement, which remain subject 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 a generic version of lamotrigine chewable tablets (5mg and 25mg) in the US.
In addition, Teva has been granted the exclusive right to manufacture and sell its own generic version of lamotrigine tablets (25mg, 100mg, 150mg, and 200mg) in the US with an expected launch date in 2008.
Additional terms of the settlement agreement were not disclosed.
Lamictal is an anti-epileptic drug (AED) belonging to the phenyltriazine class and is chemically unrelated to existing AEDs, according to the product’s prescribing information. It is indicated for the treatment of partial seizures in adult and pediatric epilepsy patients and for the maintenance treatment of mood episodes in patients with bipolar I disorder.