Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (US FDA) for its lacosamide oral solution, 10 mg/ml, the generic version of Vimpat Oral Solution, 10 mg/ml of UCB, Inc. Glenmark will market this product upon receiving final approval of its lacosamide oral solution, 10 mg/ml ANDA.
The patent listed in the Orange Book for Vimpat Oral Solution, 10 mg/ml is scheduled to expire on March 17, 2022.
According to IMS Health sales data for the 12 month period ending January 2016, the Vimpat market achieved annual sales of approximately $55.4 million.
Glenmark’s current portfolio consists of 108 products authorised for distribution in the US marketplace and 61 ANDA’s pending approval with the US FDA.
In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.