Dr. Reddy’s Laboratories in Princeton, N.J., announced last week that they are bringing a single dose generic version of Narcan to market.
The pre-filled, single-dose injectable dose of naloxone hydrochloride is a drug used to reverse opioid overdoses. Naloxone is an opioid antagonist that binds to opioid receptors. It is commonly used to reverse and block the effects of opioids and quickly restore a person who is in the midst of an opioid overdose on heroin or prescription pain medications.
The FDA has approved three different versions of Naloxone. Currently, several pharmaceutical companies offer vials of naloxone. A handheld, self-injectable version is available under the brandname EVZIO, and Narcan is available as a single-dose nasal spray. The drug may be administered intramuscularly, intravenously, or subcutaneously.
“We are pleased to bring our second product to market that has been designated as a Competitive Generic Therapy (CGT) by the USFDA,” said Marc Kikuchi, CEO of North America Generics at Dr. Reddy’s Laboratories. “With a CGT designation, we have 180-day CGT exclusivity to market this product.”
Intravenous injections are the recommended method of dosing in emergency situations.
Dr. Reddy’s said the injectable naloxone had sales of an estimated $31 million over the past year.