FDA Gives Teva Green Light for First Generic EpiPen

The FDA cleared the first generic version of EpiPen and EpiPen Jr, an epinephrine auto-injector for severe allergic reactions, 2 years after generic drugmaker Teva Pharmaceuticals was first turned down in its bid to win approval for the device.

The Teva device is the first-ever generic to the one marketed by Mylan, which is still in short supply during the busy back-to-school season in pharmacies due to production issues at Pfizer, which makes the device.

During those 2 years as Teva waited for approval, Mylan, along with insulin companies, became some of the most public corporate faces of drug pricing issues, since epinephrine, like insulin, is an old drug that as a basic compound costs a fraction of its selling price.

Epinephrine saves patients who have gone into anaphylaxis, making devices that deliver an automatic injection essential. When they expire, they must be replaced if they haven’t been used, and it is typical for schools to ask parents whose children have severe allergies to replace injectors at the start of each school year. Families usually keep multiple sets on hand at school, home, and daycare, and when prices started spiking, the costs hit hard, especially with rising copayments, cost sharing and high-deductible health plans.

Read more about insurance designs and the cost of epinephrine.

“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,” said FDA Commissioner Scott Gottlieb, MD, in a statement.

In 2017, HHS estimated that taxpayers overpaid $1.27 billion for Mylan’s EpiPen, and Heather Bresch, the company’s chief executive officer, was the focus of Congressional hearings in 2016.

In response to the rising prices of Mylan’s branded devices, CVS and Cigna stopped covering them, opting last year to include either the company’s “authorized generic” or a different device, the Adrenaclick, made by a different company.

Mylan was also hit with a class action lawsuit claiming the company struck a deal with pharmacy benefit managers over the price of the auto-injectors. The 2-pack injection cost less than $100 in 2007 when Merck was distributing it, and by summer 2016, the price crossed $600.