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Teva received approval to market generic versions of Mylan’s epinephrine auto-injector for emergency treatment of allergic reactions for both adults and children in August 2018 after several years of delays in getting the generics approved.
Teva Pharmaceutical EpiPen Jr. (epinephrine) auto-injector 0.15mg is market at a wholesale cost of $300 per two-pack.
This is the first generic alternative for the EpiPen, a life-saving emergency allergy medicine, two years after soaring prices for the original version owned by Mylan stoked controversy.
The EpiPen is designed to automatically inject a dose of epinephrine into a person’s thigh to stop an allergic reaction, whether to bee stings, peanuts or other foods, medications, latex or other causes.
Anaphylaxis is “a medical emergency that affects the whole body and, in some cases, leads to death,” affecting about one in 50 Americans, the FDA said.
People who have suffered from anaphylaxis once face a continual risk of another episode and must carry an emergency dose of epinephrine at all times.
Mylan Pharmaceuticals, which makes the EpiPen, faced an outpouring of criticism after it raised the price of a pack up two to $600 in 2016. The same package cost $100 in 2008. Currently, EpiPens cost about $630 to $700 without insurance.
Most children and adults with severe food or insect allergies carry a device wherever they go and leave a spare at home, school or work. Children with severe allergies have now access to generic version of EpiPen and EpiPen Jr. epinephrine auto-injectors. The new generic version retails for about $225 to $425.
“Many patients rely on self-injectable epinephrine products, such as EpiPen, to reverse life-threatening reactions to bee stings or other allergens for either themselves or for their children. We are doing everything we can to help mitigate shortages of these products, especially ahead of the back-to-school season,” said Janet Woodcock, M.D. from the FDA Center for Drug Evaluation and Research Director.
Children with severe allergies soon will have access to a new generic version of EpiPen and EpiPen Jr. epinephrine auto-injectors.
“Approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S. is part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval,” said the FDA Commissioner Scott Gottlieb, M.D.
“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.”
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