The upcoming EpiPen patent expiration on 11 September 2025 units the stage for a pivotal shift within the epinephrine supply market.
Mylan acquired the rights to the injector pen for treating anaphylactic reactions following the $6.7bn acquisition of Merck KGaA’s generics enterprise, Merck Generics, in 2007.
Mylan has since confronted criticism for inflating the worth of EpiPen and constraining affected person entry. The corporate has confronted quite a few lawsuits through the years in relation to overcharging drug wholesalers for entry.
In 2020, Mylan merged with Upjohn, Pfizer’s off-patent drugs division, to type Viatris.
In January 2025, Mylan reached a $73.5m settlement with KPH Healthcare Companies following accusations that it conspired with Pfizer and Teva Prescription drugs to delay the discharge of generic EpiPens, thereby sustaining a monopoly and inflating costs for epinephrine autoinjectors.
The lawsuit contested that costs for a two-pack of EpiPens rose from round $100 in 2008 to $600 through the class interval between March 2014 and February 2025.
Based on Dr Stuart Grant, principal guide at UK-based medtech guide Archetype MedTech, the patent expiration’s instant impact will result in an increase in generic rivals.
“A rise in generic choices is prone to decrease costs significantly, increasing decisions for shoppers and healthcare suppliers. Larger availability of reasonably priced choices may enhance entry for people and households who beforehand discovered it too costly,” Grant mentioned.
With the patent expiration, Grant foresees Viatris dealing with pressures to chop costs or introduce new monetary help programmes to take care of its market share.
“The model may additionally discover creating next-generation units, enhancing person expertise, or making use of for secondary patents to remain aggressive. These methods, generally known as ‘evergreening’, may draw regulatory consideration relying on their intent and market affect,” Grant defined.
Epinephrine injector rivals have beforehand needed to develop their units round EpiPen’s patented spring-loaded mechanism, a actuality that restricted their skill to copy or enhance upon the core supply system.
“They may now be capable of use the unique design as a basis, incorporating enhancements reminiscent of higher ergonomics, child-friendly options, or smaller type components,” Grant mentioned.
“The elimination of patent obstacles additionally paves the best way for modern applied sciences – Bluetooth monitoring, dose reminders, and digital well being integrations can now be layered on prime of the legacy design.