Epinephrine Auto-Injector Manufacturer Sues State Over Affordability Program

As allergic consumers grapple with the high cost of life-saving epinephrine auto-injectors — which can run up to $600 for the un- or underinsured — a handful of individual states have stepped into the fray. One such state, Colorado, passed epinephrine affordability legislation that took effect on January 1.

The legislation requires health insurers to cap the cost of auto-injectors at $60 per two-pack. It also requires pharmacies to provide auto-injectors with the same $60 price cap to those whose insurance doesn’t cover them and requires manufacturers to replace them free of charge or reimburse the pharmacy for each auto-injector sold under that requirement.

Now, one manufacturer is pushing back.

Amneal Pharmaceuticals, an NJ-based company specializing in generic and specialty drugs, has sued the State of Colorado in federal court to block the reimbursement requirement. Amneal markets a generic version of the Adrenaclick auto-injector, which CVS currently sells for $109.99.

In the complaint, Amneal claims it has had to replace 304 injectors since the program began and says:

Colorado’s reimburse-or-resupply requirement plainly effects an unconstitutional, ‘per se physical taking’ of Amneal’s personal property in violation of the Fifth Amendment.

State affordability legislation is being introduced after years of price gouging during which the price of Viatris’ — formerly Mylan — EpiPen brand auto-injector was raised sixfold in less than a decade. The company reached a $465 million settlement with the Department of Justice in 2017 over claims it employed anti-competitive tactics to drive up the price, and in 2022 agreed to pay $264 million to settle related private litigation.

Pfizer, which manufactured the device for Viatris, also reached settlements with private plaintiffs totaling almost $345 million.