Teva said Tuesday that its generic version of Mylan's EpiPen Jr (epinephrine), which is delivered at a 0.15-mg dose for patients weighing 15 kg to 30 kg, is now available in most retail pharmacies in the US at a wholesale acquisition cost of $300 for a twin pack. Teva's product, in both the 0.15-mg dose as well as the 0.3-mg strength for patients who weigh 30 kg or more, gained FDA approval in August last year as the first generic version of the auto-injector for the emergency treatment of allergic reactions. Shares in Teva were up as much as 10% on the news.
Brendan O'Grady, head of Teva's North America commercial operations, stated "we will continue working to ensure availability of both strengths in the US and plan to accelerate production to meet the urgent need for this medicine."
Last November, Teva introduced a "limited quantity" of the 0.3-mg dose of EpiPen in the US, indicating at the time that "an additional supply" of the product, as well as a generic version of EpiPen Jr would be released this year. Teva previously estimated that its generic version of EpiPen could capture 25% of the US market by the end of 2019.
Raymond James analyst Elliot Wilbur, who estimates the current US epinephrine market is worth about $700 million, remarked that "Teva can capture about $290 million to $300 million in annual sales, or roughly 45% market share."
The FDA added Mylan's EpiPen to its drug shortage list in May 2018, after the company had disclosed that Pfizer's Meridian Medical Technologies unit, which manufactures all EpiPens sold globally at a single plant near St. Louis, Missouri, had widened a recall of the auto-injector to include the US.
Mylan launched an authorised generic version of EpiPen in 2016 at a cost of $300 per two-pack amid scrutiny by US lawmakers over the branded product's increased pricing. Kaléo re-introduced its epinephrine auto-injector Auvi-Q to the US market the following year.
In addition, Novartis launched Symjepi (epinephrine) in January of this year in hospitals after gaining US marketing rights to the product from Adamis Pharmaceuticals in 2018. The launch was expanded last month to include local pharmacies across the US in response to ongoing shortages of Mylan's product.
Meanwhile, Teva said its generic versions of EpiPen and EpiPen Jr use Antares Pharma's VIBEX device, adding that the companies have an exclusive licencing, development and supply agreement covering Teva's epinephrine auto-injector products in the US.
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