A generic version of EpiPen is finally being approved by the FDA — and with a looming shortage, it couldn't be better timing

The US Food and Drug Administration approved a generic version of the EpiPen on August 16, which is a life-saving tool for people with severe allergies that injects them with a dose of epinephrine, known by its more common name, adrenaline.

There are more than 3.6 million people in the US with severe allergies and in Canada, one in 13 people have a severe food allergy that might warrant the need for an EpiPen. These tools are covered by most provincial drug plans in Canada but in the US, those without insurance must choose between generic alternatives or to go without, risking a serious reaction.

With high prices of the EpiPen causing people to come to Canada to purchase the drug and both the US and Canada facing shortages that could drag on into 2019. Health Canada has warned this week that they will be in short supply at pharmacies and though shipments will still be supplied across the country, there will most likely be limited supply going into the new year. In fact, Health Minister Ginette Petitpas Taylor has signed a temporary order allowing Auvi-Q auto-injectors to be imported into Canada for a period of two weeks, and is seeking to extend that time to one year.

This decision comes more than two years after STAT reported that Mylan, the producer of EpiPen, has raised the price of the devices by more than 450 percent over the last nine years. Since the EpiPen was approved by the FDA in 1987, there has been a stronghold over the market for these injectors, but since there was no competition, the company has been able to charge whatever it wants. Through some clever marketing techniques and branding gimmicks, Mylan has turned the EpiPen into a household name synonymous with the word allergies.

Cigna, a top insurance company in the US, previously announced that it will only cover the generic version of the drug since the price increased so rapidly.

There have been alternatives to the brand-name in the past — Auvi-Q, voice-enabled one that was recalled last year and the now-discontinued Twinject — but with most others now unavailable, there isn't much option for consumers. However, now that Teva Pharmaceuticals has received clearance from the FDA to manufacture generic versions of the EpiPen and EpiPen Jr. after years-long delays, prices should fall as Mylan faces more competition.

Average EpiPen prices in the United States

EpiPen's are currently priced at $600 USD for a two-pack, the number of pens recommended that someone with severe allergies carry with them, though this price might be cheaper depending on someone's insurance and benefits. Oddly enough, Mylan introduced its own generic form of the EpiPen in 2016, which is exactly the same as the original but without the brand name for costing $300 for a two-pack.

The company, led by Heather Bresch — who, by the way, talked West Virginia University officials into faking her master's degree, an investigation found — makes $274 from each $608 pack of EpiPens it sells because of the list of middlemen it goes through before reaching the customer. But if the company cuts out the middleman, it can pocket the full $300 price, making it a few more dollars for each one sold to consumers, depending on shipping costs. It's smart for Mylan to release a generic version from a business perspective because the lower price will also entice people to purchase an extra pen for emergencies.

Even with all the discontinuations luckily EpiPen isn't the only epinephrine injector on the market; there's a cheaper version called Adrenaclick is available for $109 at CVS and Target, according to GoodRX. Generic drugs contain the same ingredients as the name-brand ones, but might operate differently than them.

One of the main issues with the lack of options is due to the backlog of generic drugs waiting to be approved by the FDA, which is currently numbering in the thousands and according to the Generic Pharmaceutical Association, it takes on average around four years for a generic drug to be approved.

Mylan initially patented the technology used to make EpiPens from Merck in 2007 when they were priced at $57 each, but now they can range from $300 with insurance to more than a thousand dollars for people with high deductibles. Each device lasts for approximately one year before expiring, meaning patients have to fork out the cost of EpiPens annually.

📸: Flickr