While numerous companies attempted to set foot in the epinephrine auto-injection market, none were able to significantly impact Canonsburg, Pa.-based Mylan's control of the market. This dominance allowed Mylan to make major price hikes to its EpiPens, increasing the price by more than 400 percent since 2007 to $608.
Here are five reasons Mylan's EpiPen has little to no competition, according to STAT.
- Patent protection. Mylan holds a patent for its EpiPen protecting the device from competition until 2025. The Food and Drug Administration has guidelines to standardize the way epinephrine injection devices work. Companies often struggle to develop a competing device that meets industry standards without infringing on Mylan's patent.
- Developmental complexities. While an EpiPen seems like a basic device, the auto-injector is actually fairly difficult to develop. EpiPens are composed of 26 different parts and must be able to reliably deliver a consistent dose of epinephrine within seconds, according to the report. "It's a tough thing to nail down the drug supply chain, the plastics and design, and then incorporate that all together, and put the drug inside it — and then regardless of how the user uses it, get the appropriate dose within the acceptable limits of the FDA," said Chris Stepanian, CEO of Windgap Medical, a Somerville, Mass.-based startup that has been working on a next-generation epinephrine auto-injector for five years.
- Consumers stick with what they know. Valencia, Calif.-based startup MannKind is developing an inhalable form of epinephrine as a variation to Mylan's EpiPen. The company already offers an inhalable form of insulin for diabetics. Sales of the drug have been far lower than expected, as patients are less willing to switch from the familiarity of insulin injections to an inhaler. Allergy patients may show the same hesitation in switching to an inhalable form of epinephrine. Plus, the report suggests it may be difficult for patients to use an epinephrine inhaler since one of the symptoms of anaphylactic shock is a constricting airway.
- FDA approval is slow and expensive. The difficulty of maneuvering the regulatory process discourages many companies from seeking approval for a competing epinephrine auto-injector. "The only time it makes economic sense to take the risk of going through these clinical trials is when you have a situation like this," said Mark Baum, CEO of San Diego-based Imprimis Pharmaceuticals, who is developing a cheaper version of the EpiPen. "But when the market was more normalized — when the EpiPen was only retailing around $100 — competitors questioned whether it was worth taking that risk."
- No public pressure to innovate. The EpiPen's design is less than perfect. It is bulky, the epinephrine is not shelf stable and can degrade at low or high temperatures. It also expires in a year and is not very user-friendly, as users sometimes mistake which end contains the needle and stab their thumbs instead of thighs, according to the report. Most consumers have not spoken out about these flaws or pressured the company to update the device. "I guess Mylan's motto is, 'If it ain't broke, don't fix it,'" said Denise Clark, whose son has a peanut allergy and has been buying EpiPens every year for the last 16 years. "They have such a monopoly, so why would they bother improving the EpiPen?"