Drug Delivery

 Epipen: from monopoly to multiplicity  

EpiPen, the brand name given to epinephrine injectors used across the world, has become synonymous with pharmaceutical greed after the patent holder Mylan was shown to have gradually hiked prices from around $50 to over $600. Now, generic versions are starting to appear, introduced first by Teva and now Adamis. Charlotte Edwards examines the role these injectors serve, and how new challengers could affect the market.


n epinephrine auto-injector, commonly referred to as an EpiPen, is a medical device used to inject a measured dose of epinephrine, also known as adrenaline. It is often used for the treatment of anaphylaxis, a serious allergic reaction, and any patient at risk of an anaphylactic reaction is advised to carry an adrenaline auto-injector with them at all times. A shot of adrenaline during an anaphylactic shock can be the difference between life and death.

While Mylan Pharmaceuticals owns the rights to the EpiPen brand and patent, the devices are actually manufactured by Pfizer. Mylan has come under scrutiny over the past few years as a result of drastic price hikes and an anti-trust investigation into the company, which was opened by the New York State Attorney General in 2016.

Notably, prices of the EpiPen rose from $57 in 2007 to around $600 in 2016. Public backlash against this increase pushed Mylan to introduce its own generic version of the EpiPen that same year, which costs $300 for a pack of two.

Last year, the US Food and Drug Administration (FDA) had to issue a supply shortage alert for EpiPen and other epinephrine auto-injectors after patients and pharmacists in 45 US states reported it was difficult to access the lifesaving treatment. Mylan blamed the supply constraints on manufacturing delays from Pfizer.

Although the global shortage is said to have largely been resolved (the Australian Therapeutic Goods Administration for example announced in January 2019 that the shortage of EpiPen 300mcg adrenaline auto-injectors was finally over) some health professionals and patients are still reporting difficulties when trying to get hold of the devices.

Availability of competitor devices, however, is about to change drastically. The first generic version of the EpiPen and EpiPen Jr auto-injector was approved by the FDA in August 2018. This generic auto-injector is available in 0.3mg and 0.15mg strengths and is marketed by Teva. At the start of this year another contender entered the ring as Adamis Pharmaceuticals and its commercial partner, Novartis’ Sandoz unit, announced the launch of the 0.3mg Symjepi, a prefilled epinephrine syringe.

 Brand vs generic: what’s the difference? 

Critics of Mylan have previously argued that the design of its EpiPen devices needs improvement as they are often lambasted for being bulky, not having a shelf life that is much longer than a year and having a design which is not clear for someone who is a first time user or inexperienced at injecting.

Up until recently, Mylan has had no real competitors and therefore no real need to change a design and brand which is trusted by many. However, some of the new generic EpiPen’s entering the market offer an alternative design to the original Mylan device.

There is always some learning curve with these devices.

GlobalData healthcare analyst Rose Joachim said: “While Teva’s epinephrine auto-injector is a generic version of Mylan’s EpiPen, Adamis and Sandoz’s Symjepi is actually a unique new epinephrine administration device that functions as a manually-administered, pre-filled syringe rather than an auto-injector. Although it may sound preferable to have a device that automatically injects epinephrine during an anaphylactic emergency, ease-of-use studies conducted by Adamis suggest that their product may in fact be easier to administer correctly.

“Size is also a huge differentiator for Symjepi; the device is about three quarters that of the EpiPen and EpiPen generics. This may make it easier for patients to carry their epinephrine with them wherever they go.”

She added: “The only issue that Symjepi might face as a new type of injection device is the learning curve for patients switching from an auto-injector device. However, there is always some learning curve with these devices, even when switching between different types of auto-injectors.”

 How will generic EpiPens change the market? 

The introduction of new generic versions of the EpiPen to the adrenaline injector market was expected to bring prices down and some of the manufacturers even promised consumers that this would be the case. However not all of the generic EpiPen developers dramatically reduced prices.

Joachim observed: “So far, Teva has done little to bring down patient costs for their injection device. Teva’s generic epinephrine auto-injector is the same price as Mylan’s authorised generic, which is $300 per two pack. On the other hand, at $250 per two pack, Adamis and Sandoz fulfilled their promise to consumers by making Symjepi the most inexpensively priced epinephrine injection device on the US market. This 16% price difference may be enough to drive Teva and Mylan to bring down the prices on their epinephrine injection devices in turn.

This 16% price difference may be enough to drive Teva and Mylan to bring down the prices.

“Additionally, the availability of a wider variety of epinephrine injection devices on the market may also help to improve lingering issues of inadequate supply.”

Teva CEO Kare Schultz announced at a news conference in Israel in February 2019 that he expects his company’s generic version of the Mylan EpiPen to claim 25% of the US market by the end of this year and estimated a 50% market share by the end of 2020. The US EpiPen market is worth around $750m a year.

It's clear that the end of Mylan’s monopoly will open rich new pastures for competitors, but whether this will result in lower prices for people dependant on the devices is less clear. At the very least the desire to capture lucrative customer loyalty should inject some life into innovation in this space.