Teva Pharmaceuticals (NYSE:TEVA), which won the historic approval, plans to market the generic epinephrine auto-injector in 0.3mg and 0.15mg doses. There are other epinephrine auto-injectors on the market in the U.S., but Teva’s is the first that’s approved to directly substitute the Epipen.
“Today’s 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,” FDA commissioner Dr. Scott Gottlieb said in prepared remarks.
“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. The path to developing generic drug-device combination products like this one is challenging. We remain committed to doing our part to provide scientific and regulatory clarity for sponsors seeking to develop complex generics, as well as prioritize the approval of medicines with little or no generic competition as part of our overarching effort to remove barriers to generic development and market entry of critically important medicines,” he added.
An authorized generic, according to the FDA, is made using the same formulation, process and manufacturing facilities as the ones used by the brand-name manufacturer. The labeling and packaging are different between generic devices/drugs and their brand-name counterparts.
While Teva has not yet revealed the cost of its generic Epipen, advocates are hoping that it will be a cheaper alternative to Mylan’s branded device. The company has weathered intense scrutiny in recent years after reports showed that it hiked the price of its Epipen device from $100 in 2007 to more than $600 in 2016.