U.S. regulators cleared the first generic competitor to Mylan's (NASDAQ: MYL) EpiPen, after a lengthy delay that many said contributed to the emergency allergy drug's rapid rise in price.
Teva Pharmaceuticals (NYSE: TEVA) received Food and Drug Administration (FDA) approval for generic versions of both the EpiPen and EpiPen Jr, the agency said in a statement Thursday.
The products are the first competitors cleared by the FDA that are direct generic copies of the EpiPen and could be substituted for the brand-name product by a pharmacist. Other versions of epinephrine auto-injectors, such as the Adrenaclick and Auvi-Q, are on the market, but aren't considered EpiPen generics.
It may be an especially welcome time for a new entrant into the market, as the EpiPen has been facing supply issues, according to Mylan and Pfizer, which makes the EpiPen in a partnership with Mylan.
"We're applying our full resources to this important launch in the coming months and eager to being supplying the market," Teva said in a statement. The company didn't provide any details about specific timing or the planned price.
Mylan introduced its own authorized generic form of the EpiPen in late 2016, after an uproar about the branded version's price, which rose more than 400% over a decade. The authorized generic, identical to the original except without the brand name, cost half the price: $300 for a two-pack.
Teva stock slouched 47 cents, or 2%, to $23.64 Friday, while Mylan prices improved 19 cents to $38.04
