Kaléo, a privately held pharmaceutical company, plans to offer an authorized generic of its Evzio (naloxone HCl injection) take home naloxone product at a list price of $178 per carton (each carton contains two auto-injectors).
Offered through Kaléo subsidiary IJ Therapeutics, the authorized generic will be made available in midyear 2019 well in advance of Evzio’s patent expirations. The authorized generic is the same formulation, design, and meets all of the same quality standards as the branded drug, but will have a different label, according to the company. Kaléo will continue to market and distribute Evzio.
“With approximately 130 people dying daily from opioid overdoses, we recognize that more needs to be done to improve access for patients,” said Spencer Williamson, president and CEO of Kaléo. “We have been working for some time with the major pharmacy benefit managers and insurers to identify solutions for removing barriers and restrictions that may impede access. We are encouraged by these ongoing conversations and are confident that introducing an authorized generic is the most efficient way to provide greater coverage of a lower priced option—with the least amount of disruption to the healthcare system.”
Evzio is the only FDA-approved naloxone auto-injector with voice and visual guidance that talks the user step by step through the administration of naloxone to reverse the effects of an opioid overdose.
Presently, Evzio is available for $0 out-of-pocket to eligible patients with commercial insurance. The lower list price of the authorized generic will offer a more affordable and cost-effective solution for Medicare Part D patients and plans.
In addition, effective immediately, Kaléo is introducing new Public Access Pricing for Evzio of $178 per carton (two auto-injectors per carton, $89 per dose). Government agencies, first responders, health departments, and other qualifying groups on the front lines of the nation’s opioid overdose crisis are eligible for this price when they purchase directly from Kaléo or authorized distributors.
(Source: Kaléo, Inc.; AP Photo/Ted S. Warren)