The authorized generic to EpiPen®
(epinephrine injection, USP) Auto-Injector
Epinephrine Injection, USP Auto-Injector is the authorized generic to EpiPen® Auto-Injector, indicated for the emergency treatment of the signs and symptoms of anaphylaxis, including pruritus, urticarial, angioedema, flushing, syncope, tachycardia and dyspnea due to laryngeal spasm and/or a decrease in blood pressure.1
What is an authorized generic?
According to the Food and Drug Administration (FDA), the only difference between an authorized generic and a brand name product is the label. They are exactly the same, except the authorized generic does not bear the branded name.5 A company can create and sell an authorized generic of a branded product it already produces under a previously approved New Drug Application (NDA).5
What does that mean for patients?
Mylan is launching the first authorized generic to EpiPen® Auto-Injector at a list price of $300 per generic EpiPen® two-pack carton, which represents a discount of more than 50% to the Mylan list price, or wholesale acquisition cost (“WAC”), of the branded medicine. The device functionality and drug formulation are identical to the branded medicine.
Mylan is distributing the authorized generic as it would any other generic medicine working with all parts of the generic drug value chain. Savings for the patient will be determined by their healthcare insurance coverage