Teva’s Generic EpiPen Gets FDA Approval and Drives Mylan’s Stock Down

by | Aug 20, 2018 | NEWS

The FDA announced Thursday the approval of Teva Pharmaceutical’s (NYSE: TEVA) generic version of the EpiPen and EpiPen Jr. The approval comes after a years-long delay which has contributed to the shortage of EpiPens and the rising costs of Mylan’s (NASDAQ: MYL) brand name EpiPen which has been in the headlines repeatedly in the last year.

The EpiPen is a drug/device combination which allows patients to inject epinephrine directly into their thigh in the event of anaphylaxis.

Mylan’s EpiPens retail for about $600 for a two-pack. Patients must carry two auto-injectors with them at all times. After intense backlash at the rising costs of the drug, Mylan issued an authorized generic in 2016, with a cost of $300 per two-pack.

While there are other brands of epinephrine auto-injectors on the market, like Auvi-Q and Adrenaclick, they aren’t generics. They are brand-name competitors.

“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,” said FDA Commissioner Scott Gottlieb, M.D. in Thursday’s press release.

Mylan has made headlines lately with their rising prices and monopoly on the EpiPen’s easy-t-use system which is critical for those with life-threatening allergies. The new generic will mean fewer sales for Mylan and more availability for those who need the life-saving drug.

The approval of a competitive generic couldn’t come at a worse time for Mylan.

The drug company’s stock has been struggling with all the bad press, and the recent supply shortage has compounded the issue. The approval of this generic just made it even worse.

Mylan’s stock dropped 1.3 percent Thursday to $37.31, while Teva’s stock jumped to $23.88, up six percent.