We've seen recently that the price of epi-pens has been jacked up six-fold due to one company having a monopoly on the market.

Medically this is quite important as anaphylaxis can kill in seconds.

My question is: Why aren't there any competitors in the market for epi-pens?


The Ludwig von Mises Institute (Economy Institute) has recently written an article about the lack of EpiPen Competitiors. It provides a good summary:

EpiPen is sold by Mylan, and the price for a pack of two has increased from about $100 in 2007 to over $600 as of May 2016. (...) With the FDA, patents, and cozy insurance relationships, Mylan has been able to steadily increase the price of EpiPens without significant market repercussions.

Epinephrine is extremely cheap—just a few cents per dose. The complications come from producing the easy auto-injecting devices. Mylan “owns” their auto-injector device design, so competitors must find work-arounds in their devices to deliver the epinephrine into the patient’s body.

A French pharmaceutical company offered an electronic device that actually talks people through the steps of administering the drug, but it was recalled because of concerns about it delivering the required dose. Just this year, Teva Pharmaceutical’s attempt at bringing a generic epinephrine injector to market in the US was blocked by the FDA. Adrenaclick and Twinject were unable to get insurance companies on board and so discontinued their injectors in 2012.

Adrenaclick has since come back, but it is still not covered by many insurance plans, and the FDA has made it illegal for pharmacies to substitute Adrenaclick as a generic alternative to EpiPen. Another company tried to sidestep the whole auto-injector patent barrier by offering prefilled syringes, but the FDA has stalled them, too.


Here another source in the NY Times which provides some insights too:


  • 2
    It's part regulatory, but I'd say that's more or less standard for a new product. The problem here is that the market is too small to justify large expenses to get past the FDA (because everything has to be tested & equivalence has to be proven). Competitors also run the risk that when they finally enter the market, Mylan will just return the price to $100, ruining all profit margins.
    – VonBeche
    Aug 26 '16 at 12:02

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