Viatris was formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer. Viatris sells the EpiPen (epinephrine injection, USP) 0.3 mg and EpiPen Jr (epinephrine injection, USP) 0.15 mg, which are single-dose auto-injectors and combination products containing drug and device components. EpiPens are manufactured by two Pfizer subsidiaries, King Pharmaceuticals and Meridian Medical Technologies.
EpiPen and EpiPen Jr are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. EpiPen and EpiPen Jr are intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions.
Over 3.6 million prescriptions for the EpiPen were written in 2018. The EpiPen has a maximum 18-month expiration date from the date of manufacturing, which insures the need for a continuing supply of the life-saving medical device.
From the time Mylan Pharmaceuticals bought EpiPen from Merck KGaA in 2007, the list price of a two-pack went from $93.88 to $608.61 (as of May 16, 2016). In 2015, Mylan’s profits from selling the EpiPen reportedly reached $1.2 billion, which represented 40% of Mylan’s operating profits that year. A class action lawsuit was filed in which the plaintiffs alleged the price increase was not the result of supply shortages or other external factors but rather by “unaccountable executives and companies who sought to profit off of human misery and fear.” In 2021, Pfizer and its subsidiaries settled the EpiPen pricing allegations claims against them by agreeing to pay $345 million while also denying any wrongdoing.
Viatris stated on February 28, 2022 in announcing its settlement of the class-action EpiPen pricing lawsuit: “The Company has agreed, subject to approval by the Court, to a $264 million settlement, while denying any allegation of wrongdoing, to resolve the EpiPen® Auto-Injector indirect purchaser class action cases pending in the U.S. District Court for the District of Kansas. The Company maintains that it acted lawfully and pro-competitively and the settlement contains no admission of liability. The Company recorded an accrual of approximately $264.0 million related to this litigation in 2021. The Board of Directors believes that this settlement is in the best interests of the Company and its stakeholders. The resolution of these indirect purchaser cases will allow the Company to move forward and continue focusing on its strategic priorities and its mission of empowering people worldwide to live healthier at every stage of life.”
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