Teva Pharmaceuticals Industries Ltd.’s generic EpiPen has been approved for U.S. use, the Food and Drug Administration announced on Thursday afternoon, clearing the path for the market-dominating product’s first true generic rival.
The development represents a success for the generic drugmaker TEVA, +6.85%[1] as the FDA previously declined to approve its treatment for life-threatening allergic reactions back in 2016.
It also comes at a time of monthslong spot shortages [2]of Mylan’s EpiPen MYL, -0.08%[3] an authorized generic also made by the company and a separate generic autoinjector.
Parents with allergic children have been worried about securing the products in time for back-to-school season, MarketWatch reported earlier this week[4].
Read more: There’s an EpiPen shortage — and parents fear for their allergic kids[5]
The new alternative should help protect against shortages as well as offer patients a lower-cost option, Food and Drug Administration Commissioner Scott Gottlieb said in a statement[6]. The regulator also noted that generic versions of products like the EpiPen, called “combination products” because they are made up of both a drug and a device, can be more difficult to make, and that it has previously put out guidance intended to clarify that development process.
The FDA approved both adult and child-appropriate dose levels of the generic epinephrine autoinjector. Teva has not yet said how much the product will cost or when it will come to market; the company did not immediately return MarketWatch’s request for comment.
See: There’s a shortage of U.S. EpiPens and other allergic reaction treatments[7]
A generic EpiPen is already available, at around $320 per two-pack, but it is sold by Mylan, the same company that sells the brand-name, which is priced at about $630 per two-pack, and came only after an outcry over the branded product’s price. These so-called “authorized generics” are viewed by experts as a way of undercutting generic competition, as new entrants typically must come in at a lower price.
Shares of the U.S.-listed Teva surged 6.5% in extremely heavy Thursday afternoon trade, while Mylan shares rose 0.4%. Rival Amneal Pharmaceuticals Inc. AMRX, -1.66%[8] which sells a generic of the epinephrine auto-injector Adrenaclick, saw its shares drop 1.4%.