First Version of Generic EpiPen Approved by FDA

On Thursday, the U.S. Food and Drug Administration approved the first version of a generic EpiPen, in a move that brings new competition for the allergy injection that is lifesaving and helped spark great public outcry over the high prices of drugs.

The generic version, developed by TEVA Pharmaceuticals USA, is the first deemed the therapeutic equal to EpiPen, which means it can be substituted automatically at the drug store counter for prescriptions for both the EpiPen and its smaller version EpiPen Jr.

The approval arrives just prior to the back-to-school season, a time when EpiPen sales typically surge as parents stock up on the injectors for their children to have at school and replace ones that are expired. There have been reports of people having difficulty filling their EpiPen prescriptions.

A spokesperson for the FDA said limited availability of the EpiPen has been experienced in certain places across the U.S., including at the pharmacy level and the manufacturer.

A spokesperson for TEVA said that the price of the drug and the launch date were not available yet, but the statement by the company suggested it would not come in time for most parents who are trying to find available EpiPens in pharmacies around where they live.

The statement from TEVA said the company was applying its full resources to the very important launch during the coming months and is eager to start supplying the U.S. market.

The EpiPen, manufactured by Mylan, injects epinephrine a hormone, into the thigh of the user to stop potentially fatal reactions to things such as peanuts, bee stings and other allergens.

Even though the key ingredient is inexpensive Mylan started increasing its price for the EpiPen in 2007 from under $100 for a two-injector pack to today’s price of $608. As a response to heavy criticism over its price, Mylan introduced its own half-priced EpiPen generic version in 2016.

Other injectors of epinephrine have received approval before, but struggled to win market share versus the brand that uses marketing and lobbying to establish close to a monopoly of the market.

The product by TEVA took a difficult path to receive approval partly because of being a complex generic, which means it has both an injector and drug. Mylan also fought to stop the approval sending the FDA a citizen petition in 2015 that said the drug was not a true equivalent.

In 2017, the drug maker Sanofi accused Mylan of using what it called in a lawsuit, illegal tactics to squeeze its injector out of the market.