New EpiPen Generic May Prevent Shortages

From RADAR on Drug Benefits

The FDA recently approved Teva Pharmaceuticals' generic version of Mylan N.V.'s EpiPen — a move the FDA says will provide a lower-cost option, though Teva hasn’t released pricing details.

"The approved ANDA [abbreviated new drug application] generic for EpiPen is a welcomed addition to the market," says Mesfin Tegenu, R.Ph., president of PerformRx, LLC. "While it is not out yet and we are not certain of the pricing, we are assuming it will be priced at the minimum similar or cheaper than the authorized generic manufactured by Mylan."

Tegenu says the timing is good for bringing the new generic Epi- Pen to market. "While we do not anticipate the Teva product being significantly less expensive than the Mylan product, it does come at a time when there are some shortages of supply," he says. "Shortages can be problematic particularly around the time that students go back to school."

In May, after consumers around the country reported difficulties in finding EpiPens to treat severe allergic reactions, the FDA announced shortages of two brands of epinephrine auto-injectors: Mylan Inc.'s EpiPen and Impax Laboratories, LLC's Adrenaclick.

"We are hoping that the increased competition may at least prevent shortages and keep the price from rising if not slightly decreasing over time," he adds.

Other generic manufacturers are unlikely to enter the market in the near future. This is due to the requirements from the FDA to demonstrate bioequivalence through five qualitative and quantitative studies.

At this time only Teva completed this requirement. Sandoz had started the process but dropped out, assumingly, due to the patent litigation and FDA requirements.