Glenmark Pharmaceuticals receives ANDA approval for Lacosamide Oral Solution, 10 mg/mL

18 Mar 2016 Evaluate

Glenmark Pharmaceuticals Inc., USA (Glenmark) 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.

According to IMS Health sales data for the 12 month period ending January 2016, the Vimpato market achieved annual sales of approximately $55.4 million.

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. 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.

Glenmark Pharma Share Price

1237.10 11.85 (0.97%)
14-Jun-2024 16:01 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1515.00
Dr. Reddys Lab 6080.25
Cipla 1565.50
Zydus Lifesciences 1110.95
Lupin 1601.00
View more..
© 2024 The Alchemists Ark Pvt. Ltd. All rights reserved. MoneyWorks4Me ® is a registered trademark of The Alchemists Ark Pvt.Ltd.