Allergy & Asthma Network Mothers of Asthmatics (AANMA)

EpiPens and So-Called “Generic” Versions: The Facts

Published June - 18 - 2010 Print This Post

Recent news reports have presented patients with conflicting and confusing information about EpiPen Auto-Injector and a so-called generic version. These articles contain information that is inaccurate, inflammatory and, in some instances, dangerous.

Mylan Specialty, the company that makes EpiPen, has issued a statement saying:

·     There is no generic version of the EpiPen Auto-Injector product on the market.

·     The U.S. Food and Drug Administration (FDA) has not approved a generic version of the EpiPen Auto-Injector.

·     No product available to patients in the U.S. has been found by the FDA to be therapeutically equivalent to the EpiPen Auto-Injector.

FDA: BX rating means that there is no product that is therapeutically equivalent to EpiPen. The FDA assigns ratings to products in its Orange Book: Approved Drug Products with Therapeutic Equivalent Evaluations. These ratings let healthcare providers and patients know whether any other products can be used as a substitute (or generic) for the brand-name product.

EpiPen Auto-Injector has a BX rating, which means that there’s insufficient data to determine whether any other products can be used as therapeutically equivalent generics.

Background. The confusion comes in because patients using Twinject – a product made by Sciele Pharma that delivered two doses of epinephrine in one pen – were experiencing technical difficulties with the product. Sciele repurposed Twinject as Adrenaclick, which dispenses one dose of epinephrine. A company called Greenstone makes a product – labeled “auto-injectable epinephrine” – that the FDA deemed to be a legitimate generic substitute for Adrenaclick. However, neither product is an FDA-approved generic for EpiPen.

In a recent update to its Orange Book, the FDA gave BX ratings to Twinject, Adrenaclick and its generic version labeled “epinephrine auto-injector.”

From Dey’s statement:

“It may be unsafe, and may be unlawful in certain circumstances, for a pharmacist to dispense a different type of epinephrine auto-injector that is not A-rated when presented with a prescription specifying an EpiPen Auto-Injector.”

If your healthcare provider has prescribed EpiPen Auto-Injector and your pharmacist dispenses another product, contact your healthcare provider.

Patients with issues or questions can contact Dey’s Medical Affairs/Customer Service office:

(800) 429-7751
Mon. – Fri., 9 a.m. – 7 p.m. ET

Report negative side effects of prescription drugs to the FDA:
(800) 332-1088 or http://www.fda.gov/Safety/MedWatch/default.htm