Teva Pharmaceuticals USA wins approval to market its generic epinephrine auto-injector in 0.3 mg and 0.15 mg strengths.

Epipen from Mylan is the most-widely prescribed epinephrine auto-injector in the U.S. for use by people with allergies against insect bites and stings, foods, medications, latex and other items. It treats anaphylaxis, an allergic response that affects the whole body that occurs in 1 out of 50 Americans and, in some cases, leads to death. The Epipen is a convenient way to carry an emergency dose of epinephrine.

There are other branded epinephrine auto-injector products approved by the US Food and Drug Administration (FDA), including Adrenaclick and Auvi-Q, and “authorized generic” versions of EpiPen and Adrenaclick produced under their corresponding existing new drug applications using the same formulation but marketed without the brand names. 

Because epinephrine auto-injectors are combination products consisting of a drug and a device, development of generic versions is more complicated than for a drug alone. The FDA typically works with generic drug developers to support the development of generic versions of these more complex combination products, providing guidance on the steps needed to submit complete, approvable applications. For epinephrine auto-injectors, FDA has published three draft or final guidance since 2009. 

Teva Pharmaceuticals USA recently received the first FDA approval for a generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients who weigh more than 33 pounds. The company will market its generic epinephrine auto-injector in 0.3 mg and 0.15 mg strengths. 

Noted FDA Commissioner Scott Gottlieb: “Today’s approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S. is part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval. This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages.” He added that FDA remains “committed to doing our part to provide scientific and regulatory clarity for sponsors seeking to develop complex generics, as well as prioritize the approval of medicines with little or no generic competition as part of our overarching effort to remove barriers to generic development and market entry of critically important medicines.”