The US Food and Drug Administration (FDA) has just approved a generic version of the EpiPen and EpiPen Jr, the department announced Thursday.
“Today’s approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the US 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,” FDA Commissioner Scott Gottlieb said in a statement.
The alternative epinephrine auto-injector will be produced by Teva Pharmaceuticals USA and come in two strengths – 0.3 mg and 0.15 mg.
This is likely to be welcome news to the one in 50 Americans at risk of anaphylaxis, a severe allergic reaction that can trigger symptoms including swelling, nausea, lightheadedness, and – in some cases – death. Products currently on the market come with a hefty price tag and have been vulnerable to drug shortages.
"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," Gottlieb added.
Teva is yet to release more information on the price and launch date but it promises to be a cheaper generic alternative.
Much of the problem with EpiPens comes down to a pharmaceutical company called Mylan. The prototype for the EpiPen (an auto-injectable device that administers doses of the hormone epinephrine, aka adrenaline) was invented in the 1970s by a man called Sheldon Kaplan, an engineer at Northeastern University. The FDA approved what was then called the EpiPen 1987 and Mylan bought up the rights in 2007.
Since then, the company worked hard (and often unscrupulously) to maintain a virtual monopoly on the market, choking potential competitors including Teva. This has been to the detriment of consumers who have seen prices for the life-saving device rocket from $57 in 2007 to $600 in 2016. In response to public outcry over EpiPen costs, Mylan released a generic option at a cheaper price – it still marketed at $300.
What's more, EpiPens have been at the center of ongoing shortages (which will affect the 2018-2019 school year) as a result of high demand and manufacturing delays, as well as reports of defective devices leading to hospitalizations and deaths. In response, consumers have started to turn away from the EpiPen brand, instead choosing cheaper alternatives like Adrenaclick, which is available for a little more than $100.
While the development of generic drug-device combination products like this is "challenging" in Gottlieb's words, it should offer more options to the consumer – and hopefully prevent more stories like Doreen Rudolph's, which went viral last month.