FDA Approves First Direct Generic Form of EpiPen in Two Decades


On Thursday, the Food and Drug Administration (FDA) approved the first direct generic competitor to EpiPen and EpiPen Jr.  Manufactured by Mylan, EpiPen, is the biggest name-brand injector drug used to treat patients with life-threatening allergic reactions and it just got its first direct generic competitor.

The FDA’s announcement paves the way for more affordable options of the lifesaving medication.

Until now, EpiPen has dominated the market for two decades without any generic, non-brand rivals. The new drug will be made by Israeli generic manufacturer Teva Pharmaceuticals.

“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 drug shortages,” FDA Commissioner Scott Gottlieb said in a news release.

FDA-approved injectors such as Adrenaclick and Auvi-Q already exist on the market, but Teva’s product is the only authorized copy of the EpiPen and could be substituted for the brand-name product by a pharmacist.

There are no details about a launch date or a possible price. Still, Brendan O’Grady, executive vice president who heads North America Commercial at Teva said the company is “applying our full resources to this important launch in the coming months and eager to begin supplying the market.”

Meanwhile, the FDA is trying to avoid an epinephrine crisis by extending the expiration date for certain EpiPens. “We are doing everything we can to help mitigate shortages of these products, especially ahead of the back-to-school season,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a written statement.

On Thursday afternoon, Mylan shares fell 0.2 percent, while Teva’s rosed 6.8 percent.  It could take multiple approved generics to enter the market before epinephrine’s price significantly drops. “The path to developing generic drug-device combination products like this one is challenging,” FDA Commissioner Scott Gottlieb said.

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