Glenmark receives tentative approval from US FDA for lacosamide tablets

The US Food & Drug Administration (FDA) has granted tentative approval for Glenmark Pharmaceuticals’ lacosamide tablets (50 mg, 100 mg, 150 mg and 200 mg), the generic version of UCB’s Vimpat tablets. Glenmark will market this product upon receiving final approval of its lacosamide tablets. The patent listed in the Orange Book for Vimpat tablets is scheduled to expire on March 17, 2022.
 
According to IMS Health sales data for the 12 month period ending September 2015, the
Vimpat market achieved annual sales of approximately $ 691 million.
 
Glenmark’s current portfolio consists of 102 products authorised for distribution in the US marketplace and 64 ANDA’s pending approval with the US FDA.