Mylan Ready To Release Generic EpiPen

Mylan (NASDAQ:MYL) CEO Heather Bresch has announced that the “authorized generic” EpiPen will be available next week. The company is introducing the generic at a price of $300 for a two-pack, half the cost of its brand-name cousin. Mylan said it is offering a savings card for eligible patients with commercial health insurance, providing up to $25 off the out-of-pocket cost for the authorized generic. Patients may also be able to get it through a patient assistance program offered by the company.

The generic is coming to pharmacies nearly five months after the company said it would be available. To make an authorized generic available, Mylan had to make sure the product worked correctly, make enough to fulfill expected demand, and create labeling and packaging for it. These types of generics are covered under the company’s initial application with the Food and Drug Administration, so Mylan didn’t have to submit a new application or wait for approval. Mylan’s website for its authorized generic notes the product’s only difference is the label.

Mylan’s authorized generic’s $300 price tag is an improvement on the current $617 list price, but is still far more than the product’s original price tag. In less than 10 years, the price for a two-pack of auto-injectors has risen from about $100 to its current price of more than $600. The original drug has been on the market for nearly 30 years.

Last summer, Mylan came under fire for raising the allergic reaction treatment’s price dramatically over the last several years. The company first tried to quiet the criticism by offering discount coupons for the brand-name drug, but that didn’t work as planned. The broad criticism helped launched a federal investigation. In October, Mylan agreed to pay $465 million to settle allegations that it overcharged the government for its EpiPen products.

An “authorized generic” product is identical to the branded product and is typically used to undercut competition. Mylan decided to create the generic even though there isn’t a strong competitor to the EpiPen right now.

However, the announcement comes just weeks after Mylan competitor Kaleo Pharmaceuticals announced it would bring the Auvi-Q epinephrine auto-injector back onto the market in 2017. The Auvi-Q, which also injects a dose of epinephrine into a person experiencing a severe allergic reaction, was pulled from the market last year after a handful of reports were received claiming that the device didn’t reliably deliver the right dose of epinephrine.