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The FDA has approved a generic version of the EpiPen.  Though pricing has not been announced, many expect that this will provide a lower cost alternative for those who need epinephrine auto-injectors for allergic reactions.

The cost of an EpiPen has become emblematic of the widely-discussed rise in prescription drug prices.  The cost of an EpiPen has gone up more than 500% since Mylan bought the rights from Merck in 2007; from around $100 to over $600.  The CEO of Mylan has testified that the company pays $35 for each one.  Other analysis has estimated the cost of materials and manufacture to be around $10 per two-pack with the cost of the amount of epinephrine delivered coming in at about $1.

Teva Pharmaceuticals, the company who just received the FDA approval for their generic version, has tried multiple times before to bring an epinephrine auto-injector to market, going as far back as 2009.  They’ve been sued by Pfizer and King as well as had their product rejected by the FDA on their path to eventual success. 

Mylan also announced its own generic version in the meantime with a list price of $300 per two-pack.  Last year, Mylan agreed to pay $465 million to settle a claim with the U.S. Justice Department that it overcharged the government for its EpiPen.  Members of Congress in both parties called the settlement too small given that an analysis by U.S. Department of Health and Human Services’ Office of Inspector General estimated that the overpayment between 2006 and 2016 may have totalled as much as $1.27 billion.