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August 17, 2018

FDA approves first direct generic competitor to EpiPen

Daily Briefing

    FDA on Thursday approved a generic version of EpiPen and EpiPen Jr that is not manufactured by Mylan—two years after Mylan came under fire for raising the devices' prices.

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    According to the Washington Post's "To Your Health," the new device "is the first to be deemed a therapeutic equivalent of the EpiPen, which means that it can be automatically substituted at the pharmacy counter for prescriptions for EpiPen or EpiPen Jr."

    Background: Mylan faces criticism for EpiPen price hikes

    Mylan's EpiPen provides a pre-measured dose of epinephrine, the hormone used to stop severe and life-threatening allergic reactions to foods, insect stings, or certain medications. More than 3.6 million prescriptions for two-packs of EpiPens were filled in the United States in 2016.

    Mylan has faced criticism, as well as several investigations and some litigation, related to increases in the list price of a two-EpiPen set from less than $100 in 2007 to about $608 in 2017.

    In response to the public concern, Mylan in 2016 launched a generic version of the device at about $300 for a two-pack. The generic has the same drug formulation and device functionality as the original and is administered in the same way.

    In addition, CVS Health in 2017 announced that it had partnered with the drugmaker Impax to begin selling Impax's competitor to EpiPen at about one-sixth of EpiPen's price. Further, Adamis Pharmaceuticals in 2017 announced that FDA had approved its new epinephrine syringe to directly compete with Mylan's EpiPen.

    Despite that competition, Mylan has held a near "monopoly" on the market for EpiPen, "To Your Health" reports.

    FDA approves generic version of EpiPen made by Teva Pharmaceuticals

    FDA on Thursday said it approved a generic version of EpiPen and EpiPen Jr made by Teva Pharmaceuticals for adults and children who weigh more than 33 pounds. FDA said the generic epinephrine auto-injector "is intended for immediate administration to patients" in the same manner as branded EpiPens.


    FDA Commissioner Scott Gottlieb said the agency's "approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S. is part of [its] longstanding commitment to advance access to lower cost, safe, and effective generic alternatives once patents and other exclusivities no longer prevent approval." He continued, "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."

    Teva spokesperson Doris Saltkill said the company has not yet released a price for its device, and it does not yet know when the device will be available in the United States. "We're applying our full resources to this important launch in the coming months and [are] eager to begin supplying the market," she said (Diamond, "Pulse," Politico, 8/17; FDA release, 8/16; Johnson/McGinley, "To Your Health," Washington Post, 8/16; Weixel, The Hill, 8/16; Kacik, Modern Healthcare, 8/16).

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