The First Generic EpiPen Just Received FDA Approval

For people with severe allergies, having an EpiPen on hand could mean the difference between life and death. But that safety net comes at a high price: In the past decade, the cost of the brand-name drug has risen by more than 400 percent, with a set of two pens selling for $600. Now, CNBC reports that patients can finally get the treatment they need for a more reasonable amount of cash: The FDA has approved a generic version of Mylan's EpiPen, making it the first direct generic competitor to the brand-name medication.

Teva Pharmaceutical's versions of both the EpiPen and EpiPen Jr. will work like the originals, with an injector delivering epinephrine, a chemical that opens the airways, into the bloodstream of someone suffering an allergic reaction. Similar generics have been made commercially available in the past: In 2016, Mylan introduced a cheaper version of its own product at $300 for a two-pack, and in 2017 CVS started selling an EpiPen alternative for $110. Teva's drug is different, though. It's a direct generic copy of the EpiPen, which means pharmacists will be free to offer it to patients who have been prescribed Mylan's product. A price hasn't been announced, but Teva's EpiPen could end up being significantly cheaper than Mylan's generic EpiPen, which could in turn bring down prices of the injector drug across the board.

The exorbitant price of the EpiPen has hit patients hard in recent years. Some EMTs have even started loading epinephrine into syringes manually rather than paying for the drug-injector combo. Though the drug itself isn't protected by a patent, the design of the EpiPen device is difficult for competing pharmaceutical companies to replicate, which has allowed Mylan to charge whatever it can for the product.

In 2017, the FDA tweaked its guidelines to make it easier for generic EpiPen competitors to receive market approval, even if the design of the new injector differed slightly from the original. With the approval of Teva's auto-injector made official, more EpiPen generics could soon start appearing behind pharmacy counters.