Dr Reddy’s launches generic opioid antagonist injection in US

Drug firm Dr Reddy’s Laboratories said it has launched generic Naloxone Hydrochloride injection, indicated for complete or partial reversal of opioid depression, in the US market. The company has launched Naloxone Hydrochloride injection USP, 2 mg/2 mL (1 mg/mL) single-dose prefilled syringe after the approval from the United States Food and Drug Administration (US FDA), Dr Reddy’s said in a statement.

The product is a generic version of ADAPT Pharma Operations’s Narcan injection, it added.

“We are pleased to bring our second product to market that has been designated as a Competitive Generic Therapy (CGT) by the US FDA,” Dr Reddy’s Laboratories North America Generics CEO Marc Kikuchi said.

With a CGT designation, the company has 180-day CGT exclusivity to market this product, he added.

According to IQVIA Health data, Naloxone Hydrochloride injection USP, 2 mg/2 mL (1 mg/mL) had US sales of around USD 31 million (about Rs 230 crore) moving annual total for the most recent twelve months ended in January 2020.

Shares of Dr Reddy’s Laboratories on Thursday closed 1.69 per cent lower at Rs 2,622.75 on the BSE.