EpiPen patent expiry opens new period for innovation
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 value 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 medication division, to kind Viatris.
In January 2025, Mylan reached a $73.5m settlement with KPH Healthcare Providers 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 throughout the class interval between March 2014 and February 2025.
The generics upswell and innovation rise
In response to Dr Stuart Grant, principal guide at UK-based medtech guide Archetype MedTech, the patent expiration’s rapid impact will result in an increase in generic rivals.
“A rise in generic choices is more likely to decrease costs significantly, increasing decisions for shoppers and healthcare suppliers. Higher availability of reasonably priced choices might enhance entry for people and households who beforehand discovered it too costly,” Grant mentioned.
With the patent expiration, Grant foresees Viatris going through pressures to chop costs or introduce new monetary help programmes to keep up its market share.
“The model may additionally discover growing next-generation units, enhancing consumer expertise, or making use of for secondary patents to remain aggressive. These methods, referred to as ‘evergreening’, might 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 are going to now be capable of use the unique design as a basis, incorporating enhancements equivalent to higher ergonomics, child-friendly options, or smaller kind elements,” Grant mentioned.
“The elimination of patent limitations 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.
“Furthermore, firms can discover different formulations and supply strategies whereas leveraging the expired EpiPen mannequin for regulatory effectivity, probably qualifying for accelerated approval pathways. This reduces each improvement time and value, encouraging new entrants into the market.” Grant concluded.
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