By Beth Mole for Ars Technica
Teva Pharmaceuticals USA now has FDA approval to market a direct generic competitor of the device, as well as a version for pediatric patients, a generic EpiPen Jr. Both products are used in emergency situations to auto-inject a dose of epinephrine into a person’s thigh to thwart potentially deadly allergic reactions. In particular, epinephrine can be used to treat anaphylaxis, a life-threatening reaction in which the airways swell and narrow, making breathing difficult.
The approval comes years after Mylan outraged patients and lawmakers by increasing the price of its product by more than 400 percent.
Mylan purchased the rights to EpiPen in 2007 and gradually raised the list price from about $ 50 per auto-injector to slightly over $ 600 for a two-pack. The move boosted EpiPen profits to $ 1.1 billion a year. In step, Mylan CEO Heather Bresch saw her salary soar by millions, reaching nearly $ 19 million in 2015—a point lawmakers hammered her for during a House Oversight Committee hearing in September of 2016.
Amid the intense scrutiny, Mylan announced that it would release its own “authorized generic” version of the EpiPen. But the product debuted with a list price of $ 300 per two-pack, still triple the price of what the product cost prior to Mylan’s 2007 takeover.
Epinephrine alone is already a generic drug, and the dose in an auto-injector costs less than a dollar to make. But the EpiPen is a drug-device “combination product,” which has been tricky for rivals to replicate exactly in order to get FDA approval. Mylan has also been accused by fellow pharmaceutical companies of trying to squash rivals.
In 2009, Mylan had Teva sued for patent infringement, leading to a settlement that kept Teva off the EpiPen market until 2015. Then, in 2016, the FDA found “major deficiencies” in Teva’s application to market a rival EpiPen generic.
Since then, other makers have made different types of epinephrine auto-injectors, most notably Adrenaclick and the pricey Auvi-Q, but they work differently from EpiPen and can’t be used interchangeably like a generic version.
Teva’s long-sought generic product now offers patients that option—and the potential for lower prices.
In a statement, FDA Commissioner Scott Gottlieb trumpeted the approval as a win in the effort to drag down skyrocketing drug costs:
"Today’s approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S. is part of our longstanding commitment to advance access to lower cost, safe, and effective generic alternatives once patents and other exclusivities no longer prevent approval."
Still, Teva has yet to name the price of its generic, ensuring that the FDA’s hopes are indeed true. Two Teva spokespeople declined to reveal any hints on the device’s list price. They only provided a written statement:
"Today’s approval of our generic version of EpiPen (epinephrine injection, USP) Auto-Injector 0.3 mg and 0.15 mg in the U.S. marks an important step forward in bringing patients additional prescription medications that have met the FDA’s rigorous standards.
"We’re applying our full resources to this important launch in the coming months and eager to begin supplying the market.
"Once launched, Teva’s product will be the only generic, AB-rated/therapeutically equivalent version of EpiPen."