The U.S. Food and Drug Administration has approved a generic version of EpiPen and EpiPen Jr., the lifesaving devices carried by individuals who are allergic to things like peanuts and bee stings.
The approval allows Teva Pharmaceuticals USA to market its generic epinephrine auto-injector to treat adults and children over 33 pounds for a potentially life-threatening allergic reaction called anaphylaxis.
The U.S. Food and Drug Administration said the approval is part of its commitment to advance access to “lower cost, safe and effective generic alternatives” and to “remove barriers to generic development and market entry of critically important medicines.”
EpiPen is the most widely prescribed epinephrine auto-injector in the country and has been in short supply lately in Kentucky and elsewhere. It also was the subject of a highly publicized price hike that caused some people to pay more than $600 for a two-pack, said Chris Palutis, a Lexington pharmacist who is president of the Kentucky Pharmacists Association.
Approval of the generic version “means patients living with severe allergies who require constant access to lifesaving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages,” FDA Commissioner Scott Gottlieb said in a news release on Thursday.
Dr. Wes Sublett, a local allergist with Family Allergy & Asthma, agreed that the approval is a positive development for patients.
“The approval of a generic version of EpiPen allows patients access to another low-cost option when filling their epinephrine auto-injector,” Sublett said. “This is especially important due to the recent drug shortages we have seen for the epinephrine auto-injectors.”
However, it will be interesting to see the eventual price of the generic and how quickly insurance companies will embrace the drug, said Palutis, owner of C&C Pharmacy.
Teva hasn’t published the list price yet but released a statement saying, “We’re applying our full resources to this important launch in the coming months and eager to begin supplying the market.”
Anaphylaxis occurs in about one in 50 Americans, according to the FDA.
During an episode of anaphylaxis, epinephrine is injected into the thigh to stop the allergic reaction. It reduces swelling in the airway and increases blood flow in the veins.
Auto-injectors are in high demand around this time of year as school starts and people seek to take them to campus. Alternatives to EpiPen include Auvi-Q and Adrenaclick, according to the American College of Allergy, Asthma and Immunology.
If you can’t find an EpiPen, “your allergist will be able to prescribe you an alternative auto-injector,” said Dr. Bradley Chipps, ACAAI president, in a news release. “They can also teach you how to use them, as each device works differently.”
But you also may find that an alternative, such as Auvi-Q, is in short supply, Palutis said.