Dr. Reddy's Laboratories announced first-to-market launch of Naloxone Hydrochloride injection in the US market.
Dr. Reddy's Laboratories on Thursday (19 March 2020) 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 US Food and Drug Administration (USFDA).
The drug is used to block the effects of opioids. It is commonly used for decreased breathing in opioid overdose. Naloxone may also be combined with an opioid to decrease the risk of opioid misuse.
"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.
Shares of Dr. Reddy's Laboratories were down 3.20% at Rs 2582.45. The stock has fallen 10.63% in four sessions from a recent closing high of Rs 2889.90 recorded on 13 March 2020.
Dr. Reddy's Laboratories is an India-based pharmaceutical company. Through its three businesses - pharmaceutical services and active ingredients, global generics and proprietary products - the company offers a portfolio of products and services, including active pharmaceutical ingredients (API), custom pharmaceutical services (CPI), generics, biosimilars, differentiated formulations and new chemical entities.
The drug maker reported a consolidated net loss of Rs 538.40 crore in Q3 December 2019 as compared to a net profit of Rs 500.30 crore in Q3 December 2018. Net sales rose 13.9% to Rs 4383.80 crore in Q3 December 2019 over Q3 December 2018.
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