On Thursday (Aug. 16), the US Food and Drug Administration (FDA) approved a generic version of the EpiPen, a life-saving tool that stops severe allergic reactions with an injected dose of epinephrine, the hormone also known as adrenaline.
The decision comes two years after reporting by STAT revealed that Mylan, EpiPen’s manufacturer, had increased the price of the devices by 450% over the previous nine years. Currently, EpiPens are priced at around $600 for a pack of two (the number of pens people with severe allergies should carry, according to the National Institute of Allergy and Infectious Diseases), without insurance. There is an “authorized generic” pack, also manufactured by Mylan, that is priced around $300 without insurance. But now that a true generic has been approved, manufactured by Teva Pharmaceuticals, prices should plummet.
Since Mylan’s EpiPen was first approved by the FDA in 1987, the company has maintained a stranglehold on the market for epinephrine injectors. Recently, competitors have entered the space, including o the Kaléo’s Auvi-Q, which the company says it sells for $360, and Amedra Pharmaceuticals’ Adrenaclick, which CVS sells for $110 (both for two-packs). In 2016, a group of vigilante doctors calling themselves “Four Thieves Vinegar” posted free instructions to making an “EpiPencil” at home with materials costing just $30. Making any kind of drug yourself, though, is far from advisable, especially one that needs to stop a potentially fatal anaphylactic reaction. It was a deadly risk not many were willing to take.
Teva had been trying to create a generic EpiPen for years, according to STAT. Six years ago, Mylan and Teva settled a patent infringement lawsuit, with Teva agreeing to table their generic until 2015. But then in 2016, Teva’s first attempt at a generic was rejected by the FDA.
The news of the Teva generic comes right at the start of back-to-school season, when parents typically purchase new pens for their children who need them. However, according to the Washington Post (paywall), it seems unlikely the Teva pens will be available in time for the beginning of the school year. There is still no official information on the generic’s price or when it will be available in pharmacies.