FDA Approves First Generic Epinephrine Autoinjectors

The United States Food and Drug Administration recently announced approval for Teva Pharmaceuticals to market generic epinephrine autoinjectors.  According to the press release, Teva’s autoinjectors are the first generic versions of Mylan’s EpiPen® and EpiPen Jr ® to receive FDA approval.

Food Allergy & Research reports that as many as 15 million people in the U.S. have food allergies, which results in about 200,000 needing emergency medical care per year.  Commenting on the approval, U.S. FDA Commissioner Scott Gottlieb stated:

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.

Analyst reports indicate wholesalers are not expecting to receive the generic epinephrine autoinjectors from Teva for several months.  A Teva spokesperson commented that the company “is applying its full resources to this important launch in the coming months and is eager to being supplying the market.”  Currently, Mylan’s EpiPen® 0.3 mg autoinjector 2-pack sells for about $697 at HealthWarehouse.com.  Teva has not yet indicated the price of its generic autoinjector.

 

 

 

Mark Rubinshtein
Mark Rubinshtein's practice focuses on patent litigation and prosecution for clients in the chemical and pharmaceuticals industries. Dr. Rubinshtein earned his J.D. at University San Diego School of Law. Prior to law school, Dr. Rubinshtein obtained a B.A in Chemistry and M.S. in chemical engineering from Columbia University and completed his PhD in organic chemistry in 2011 at UC San Diego. His graduate work focused on developing targeted small molecular therapeutics for Alzheimer's disease and on devising synthetic methods for the preparation of side-chain functionalized biodegradable and biocompatible polymers.
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