- The Food and Drug Administration on Friday approved the first generic version of Narcan, a nasal spray version of naloxone that's used to reverse opioid overdoses. And more sweeping regulatory action could soon follow to further boost the availability of naloxone, agency officials said.
- Among other ambitions, the FDA is considering whether naloxone should be co-prescribed with all or some opioid prescriptions, Douglas Throckmorton, an FDA deputy director, said in a statement. Additionally, the agency is prioritizing further generic naloxone applications and is pushing for industry to develop an over-the-counter version.
- Teva did not respond to questions on pricing and availability for its newly approved generic. However, a launch does not appear imminent, as Teva remains tied up in a legal battle with Narcan's manufacturer, Emergent BioSolutions. One Wall Street analyst anticipated a trial for the patent litigation to begin later this year.
Despite the magnitude of the opioid overdose crisis, the U.S. market for naloxone remains relatively small.
Using Iqvia prescription data for the month of February, Raymond James analyst Elliot Wilbur estimated the entire naloxone market at about $290 million in annual sales. Given that market size, the analyst predicted annual sales for Teva's generic could reach between $50 million and $60 million.
However, agency action on co-prescription could expand the entire market. Last December, an FDA advisory committee voted 12-11 in support of some level of co-prescribing naloxone.
Even modest regulatory action — such as recommending co-prescribing for patients at high risk of addiction — could greatly expand the market for naloxone, Wilbur wrote in a note to clients.
Assuming at-risk patients account for 20% of opioid prescriptions, and that about a quarter of those co-prescriptions would be filled, the sell-side analyst forecasts an increase in annual naloxone sales to nearly $1 billion.
But while Narcan's nasal spray delivery is convenient, the drug and its now-approved generic are far from the only version of naloxone available. Generic injectables have been around for years from Pfizer, Mylan and a few other drugmakers. Additionally, Kaléo offers an auto-injector, Evzio, albeit at pricing levels that have elicited widespread criticism.
Emergent investors have long been expecting the approval of a generic competitor, Cantor Fitzgerald's Brandon Folkes wrote Friday. Shares in the company, which bought Narcan's maker Adapt Pharma last year, were relatively unchanged Monday, and remain down roughly 15% in the two months since the biopharma reported fourth quarter results in February.