Mylan’s brand name EpiPen (epinephrine) auto-injector is twice the cost of both generics, with a $600 (€527) price tag. Teva and Mylan’s epinephrine auto-injector generics both retail at $300 for a pack of two.
Teva’s product will be available in limited supply in the US upon launch. The Israeli generics firm has not stated the quantity of supply it intends to introduce onto the market.
Manufacturing of Teva’s product began in August 2018, following its US Food and Drug Administration (FDA) approval. The company stated that additional supply is inbound next year.
Upon US approval of Teva’s product, FDA commissioner Scott Gottlieb stated, “Today’s approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the US is part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives.”
Teva’s epinephrine injector will become the first generic EpiPen to reach the market, aside from Mylan’s own.
Demand for competition
The release of Teva’s generic comes after supply shortages of EpiPen products had an impact in North America and other regions around the world, as low levels of supply led regulatory authorities to extend expiration dates of the treatment.
Mylan stated that the shortages were related to manufacturing issues at a plant run by Meridian Medical technologies, a subsidiary of Pfizer.
Calls for competition have also been issued regarding pricing; In 2016, US Committee on Energy and Commerce expressed concerns about the lack of generic competition to Mylan’s product. The issue arose after the drugmaker increased the price of the EpiPen product by a total of 548% between 2007 and 2016.
While Teva’s product will be the first generic of the EpiPen, aside from Mylan’s, other generic epinephrine injector alternatives have reached the market. Kaleo re-launched its Auvi-Q product, in 2016, and Adamis received approval for its Sympjepi equivalent, in 2017.