India and Princeton, NJ, USA. February 2, 2021— Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced the launch of Vigabatrin Tablets USP, 500 mg, a therapeutic equivalent generic version of Sabril® (vigabatrin) Tablets, USP, approved by the U.S. Food and Drug Administration (USFDA).
“We are pleased that this product has been designated as a Competitive Generic Therapy (CGT) by the FDA,” says Marc Kikuchi, Chief Executive Officer, North America Generics, Dr. Reddy’s Laboratories. “With a CGT designation, we have 180-day CGT exclusivity to market this product.”
The Sabril® brand and generic had U.S. sales of approximately $141 million MAT for the most recent twelve months ending in December 2020 according to IMS Health. Dr. Reddy’s Vigabatrin Tablets, USP are available in 500 mg tablets in a bottle count size of 100.