Teva Pharmaceutical Industries on Tuesday released its generic version of Mylan's EpiPen for children who weigh between 33 and 66 pounds, which will be available in the majority of retail pharmacies for $300 for a two-pack, Reuters reports.

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The announcement comes amid a shortage of EpiPens in the United States, Canada, and Europe, according to FOX Business.

Background

Mylan's EpiPen provides a pre-measured dose of epinephrine, the hormone used to stop severe and life-threatening allergic reactions to foods, insect stings, or certain medications. More than 3.6 million prescriptions for two-packs of EpiPens were filled in the United States in 2016.

But Mylan has faced criticism, as well as several investigations and some litigation, related to increases in the list price of a two-EpiPen set, which rose from less than $100 in 2007 to about $608 in 2017. In response to the public concern, Mylan in 2016 launched a generic version of the device at about $300 for a two-pack. The generic has the same drug formulation and device functionality as the original and is administered in the same way.

Since then, several companies have released their own versions of EpiPen to compete with Mylan's versions. For instance, CVS Health in 2017 partnered  with the drugmaker Impax to begin selling Impax's competitor to EpiPen at about one-sixth of EpiPen's price, and FDA approved Adamis Pharmaceuticals' new epinephrine syringe.

FDA later approved a generic version of EpiPen and EpiPen Jr made by Teva for adults and children who weigh more than 33 pounds.

Teva releases generic EpiPen Jr

Teva on Tuesday announced that it has now released its generic version of EpiPen Jr, created for children who weigh between 33 and 66 pounds. The device will be available in a majority of retail pharmacies for $300 for a two-pack.

Brendan O'Grady, EVP and head of Teva's North America Commercial division, in a statement said, "We're pleased to provide access to Epinephrine Injection (Auto-Injector) in two strengths for patients who may experience life-threatening allergic emergencies. We will continue working to ensure availability of both strengths in the U.S. and plan to accelerate production to meet the urgent need for this medicine."

According to Elliot Wilbur, an analyst with Raymond James, the current epinephrine market in the United States is worth about $700 million. "Teva can capture about $290 million-$300 million in annual sales, or roughly 45% market share," Wilbur said (Banerjee/Mathias, Reuters, 8/20; Schmidt, FOX Business, 8/20; Teva release, 8/20).