Dr. Reddy's Laboratories Announces First-to-Market Launch of Naloxone Hydrochloride Injection USP, 2 mg/2 mL (1 mg/mL) Single-dose Prefilled Syringe in the U.S. Market
With a CGT designation, we have 180-day CGT exclusivity to market this product.
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.
https://www.drreddys.com/pi/Naloxone_Hydrochloride_Injection_PI.pdf
NARCAN® is a trademark of ADAPT Pharma Operations Limited
*IQIA Retail and Non-Retail MAT January 2020
RDY-0320-282
About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy’s operates in markets across the globe. Our major markets include – USA, India, Russia & CIS countries, and Europe. For more information, log on to: www.drreddys.com
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