Glenmark Pharmaceuticals receives tentative ANDA approval for Lacosamide Oral Solution, 10 mg/mL
Glenmark Pharmaceuticals has been granted tentative approval by the United States Food & Drug Administration (U.S. 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.
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According to IMS Health sales data for the 12 month period ending January 2016, the Vimpat® market achieved annual sales of approximately .4 million.
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Glenmark’s current portfolio consists of 108 products authorized for distribution in the U.S. marketplace and 61 ANDA’s pending approval with the U.S. FDA.