Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced the launch of Naloxone Hydrochloride Injection USP, 2 mg/2 mL (1 mg/mL) Single-dose Prefilled Syringe, a therapeutic equivalent generic version of Narcan® (naloxone hydrochloride) Injection USP, approved by the U.S. Food and Drug Administration (USFDA).
“We are pleased to bring our second product to market that has been designated as a Competitive Generic Therapy (CGT) by the USFDA,” 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 Naloxone Hydrochloride Injection USP, 2 mg/2 mL (1 mg/mL) had U.S. sales of approximately $31 million MAT for the most recent twelve months ending in January 2020 according to IQVIA Health*.
Dr. Reddy’s Naloxone Hydrochloride Injection USP, 2 mg/2 mL (1 mg/mL) is available in 2 mL single-dose prefilled syringe.
Please see full prescribing information.
NARCAN® is a trademark of ADAPT Pharma Operations Limited