Teva Wins FDA Approval for First Generic EpiPen

On Thursday, the U.S. Food and Drug Administration announced it has awarded the U.S. branch of Teva Pharmaceutical Industries Ltd. approval to market the first generic version of Mylan NV’s EpiPen auto-injectors.

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Amidst growing public and parliamentary criticism of rising drug prices in the U.S., under FDA Commissioner Scott Gottlieb the agency has made it its mission to slash prices and encourage the introduction of generic versions into the market. Teva itself has faced criticism over its prices, and specifically over its flagship multiple sclerosis drug Copaxone, which saw several generic versions launched in 2017 despite Teva’s legal opposition. Teva sells a monthly dose of the drug for almost $6,000.

Mylan has faced harsh criticism over the price of its brand name EpiPen. The pens inject epinephrine, a very inexpensive hormone used to treat a severe allergic reaction to food or insect stings called anaphylaxis, which can be fatal if not treated immediately. The EpiPen’s uniqueness is in its delivery system, which calibrates the dosage very precisely.

When Mylan acquired the EpiPen in 2007 from Merck KGaA, the pens cost around $57. Today the drug costs over $600 for a two-pen package. The company also sells an “authorized generic” pair for around $300.

Though Mylan controls most of the U.S. market, there is a brand competitor called Adrenaclick, a generic version of which can be bought at around $110 a pair. It uses a different delivery mechanism, though, and its makers have struggled with consistent production to meet demand. Another brand competitor, Auvi-Q, was pulled out of the market in 2015 due to quality concerns and returned in 2017 with a list price of $4,500 for insurers and a cash price of $360 a pair.

Teva has been attempting to produce a generic version for a few years, but delayed it until 2015 following a patent infringement lawsuit from Mylan. The FDA, however, only authorized Teva’s generic EpiPen now. The company has yet to announce pricing.

Teva was up 6.11% on Thursday market close on NYSE, and appreciated another 0.2% on Friday. The company is currently trending up in after-hours trading.