Teva wins FDA nod for its generic of Mylan's EpiPen after 2-year delay

The FDA has approved Teva's generic of Mylan's highly successful EpiPen. (Mylan)

After a delay of more than two years, Teva has won approval of its generic version of Mylan’s highly successful EpiPens. The approval comes at an opportune time given that manufacturing issues have made supplies of Mylan’s epinephrine injectors spotty, leaving some parents of children with life-threatening allergies frantic. 

The FDA Thursday said it had approved Teva’s copies of the EpiPen and EpiPen Jr epinephrine auto-injector in two doses, 0.3 mg and 0.15 mg strengths. They are approved for emergency treatment of allergic reactions, including life-threatening anaphylaxis, in adults and children who weigh more than 33 pounds.

“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,” FDA Commissioner Scott Gottlieb, M.D., said in the announcement.”

In an emailed statement, a Teva spokesperson said: "We’re applying our full resources to this important launch in the coming months and eager to begin supplying the market. Once launched, Teva’s product will be the only generic, AB-rated/therapeutically equivalent version of EpiPen."

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 The FDA first considered the Teva copy in 2016 but rejected it because of "certain major deficiencies," which Teva at the time said would mean a significant delay.

While Mylan’s branded EpiPen once had the market pretty much too itself, other epinephrine autoinjectors are now on the market, including a generic EpiPen from Mylan, which it introduced at the time amidst criticism over its near monopoly position and the high prices of its EpiPens. Impax Laboratories, now part of Amneal Pharmaceuticals, and Kaleo also have approved products.

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The approval of Teva’s products comes as parents of children who need the pens in the event of a severe allergic reaction have been scrambling to find replacements in some markets. Spot shortages of Mylan’s EpiPens developed last year when a Pfizer subsidiary that makes them for Mylan had manufacturing delays. The FDA this May added it and the injectors from Impax Laboratories to its drug shortages list.

In a note to clients, Wells Fargo analyst David Maris said the approval may surprise investors who were thinking it would not happen before 2019. He agreed that given reports of "widespread shortages at back-to-school time", the approval comes at an opportune moment for Teva. He pointed out that Mylan currently has about 73.5% of the epinephrine market, with its branded EpiPen at approximately 24.7% and its own generic at 48.7%. He said the latest data shows that Impax's generic has a 24.9% share and Auvi-Q approximately 2%. 

Other analysts agreed that the supply issues Mylan and Impax face presents Teva with an opportunity, they point out that the value of the market has declined since Teva first missed approval, with pricing pressure from other products. They see the Teva upside at about $300 million annually from its copy.