Generics for EpiPen and EpiPen Jr Approved
August 16, 2018 – The U.S. FDA has approved Teva’s generic versions of Mylan’s EpiPen® and EpiPen Jr® (epinephrine) auto-injectors. Teva’s generics are indicated to provide emergency treatment for allergic reactions in adults and in children who weigh at least 33 pounds. The new auto-injectors will be available in 0.3mg and 0.15mg strengths.
Mylan’s EpiPen products have famously been at the center of outrage over drug cost increases, although they remain the most widely prescribed epinephrine auto-injectors in the country. More recently, the company has been troubled by spot shortages that make the products difficult to access for some patients.
Although Mylan has marketed its own EpiPen generic in the United States since 2016, Teva’s epinephrine auto-injectors represent the first true generic competition for Mylan’s products. The FDA hopes that Teva’s generics will help ease shortages and provide patients with lower-cost options.
Life-threatening allergies affect an estimated 1 in 50 people in the United States. Many patients must keep at least two epinephrine auto-injectors on hand at any given time. In an emergency, the life-saving injectors can be used by the patient or a nearby individual to deliver a rapid-acting dose of epinephrine that helps to open airways and improve blood circulation.
Teva has not yet announced launch or pricing plans.