The U.S. Food and Drug Administration (FDA) has recently approved the first generic EpiPen to be made by Teva Pharmaceuticals. There are currently several brands of epinephrine auto-injectors available to patients: Mylan makes EpiPen, EpiPen Jr. and its own brand-sponsored generic; kaléo offers Auvi-Q; and Impax Laboratories markets Adrenaclick. However, this generic EpiPen by Teva Pharmaceuticals will be the first time a non-brand alternative is available.
Obtaining approval from the FDA for a generic was complicated by the fact that both the medication (epinephrine) as well as the device itself had to be reviewed. There is no firm estimate on when to expect this new generic on the market or the cost of the product once it gets there.
The competition generated by a generic should help the epinephrine auto-injector market. To date, Mylan’s EpiPen has nearly monopolized the market but its exorbitant cost has gained unwanted attention. Mylan’s EpiPen price has risen over 400% in the last 10 years to over $600 a set. To counter the negative press, Mylan created their own generic EpiPen which still average $300 per set. Patients and families are hoping the introduction of a true generic device will drive down the cost of the absolutely necessary, life-saving devices as well as help to prevent epinephrine auto-injector shortages like the one we’re experiencing presently. They’re also hopeful this generic will help expand options covered by their insurance plans. Doctors, emergency workers and advocates are also optimistic that this may help get epinephrine in the hands of patients who may otherwise be unable to afford it.