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The EpiPen is about to get some competition

The pharmaceutical company Mylan is already under fire from families and politicians angry about steep price hikes on its life-saving allergy drug EpiPen, but now there’s a new threat looming.

EpiPen’s former competitor Kaléo Inc. revealed Wednesday that it’s returning to the U.S. market in 2017 with its own epinephrine injector, Auvi-Q, following a two-year hiatus. Auvi-Q was pulled from pharmacy shelves in 2015 due to concerns that dosing was insufficient. Now, Kaléo says it has resolved those issues and is ready to get its product back in the hands of allergy sufferers.


Mylan has been embroiled in controversy since the summer when the high cost of the EpiPen sparked public outcry and congressional hearings. Since 2008, the cost of a two-pack of EpiPens rose more than 400 percent to more than $600. News of Kaléo’s return sent Mylan shares down more than 2 percent in midday trading.

Products like Auvi-Q and EpiPen are used to administer a shot of epinephrine to someone having an allergic reaction in order to prevent them from going into anaphylactic shock. For years, EpiPen was the only available epinephrine injector, a tool now seen as essential for people with allergic reactions to foods like seafood and peanuts. Auvi-Q quickly gained a following when it entered the market in 2013, taking 10 percent of the market by 2015, according to the New York Times.

Auvi-Q was more expensive than EpiPen back when it was still available in the U.S.; its removal from the market allowed Mylan to boost the price of the EpiPen. Kaléo told Bloomberg on Wednesday that it has yet to set a price.

“As we prepare to make Auvi-Q available once again in the United States, our priority is to return Auvi-Q to the market as an epinephrine auto-injector alternative that all patients can afford,” Kaléo CEO Spencer Williamson said in a statement.

The Auvi-Q announcement is just the latest shakeup to the epinephrine injector market since the pricing controversy took hold. Mylan has said it plans to introduce its own generic EpiPen later this year.