September 14, 2018

Why the Approval of Generic EpiPen Is a Great News?

When it comes to severe allergic reactions, epinephrine is often a life-saver. Therefore, people with a history of anaphylaxis are recommended to always have an epinephrine auto-injector at hand.


At the moment, there are three brands of auto-injectable epinephrine available in the United States: EpiPen, Adrenaclick, and Auvi-Q. EpiPen is the most commonly used one, but its price is a big issue for some people. Recently, the drug has been put on the FDA’s list of drug shortages, which has risen even more issues for users.

Fortunately, there is some good news for people with severe allergies, as the Food and Drug Administration has approved a generic version of EpiPen.

The new device was developed by Teva Pharmaceuticals USA and it’s expected to offer cheaper alternatives to EpiPen users and relieve the problems related to the supply shortage of the original medication. However, it will still take several months for the generic device to launch.

According to allergists, this can significantly improve the availability and affordability of the anaphylaxis treatment, which is a real benefit for allergy patients.

How Many People Use Auto-Injectors?


Allergies to certain foods, stinging insects, medications, or latex affect millions of people in the U.S. Exposure to these allergens may cause a severe reaction such as anaphylaxis. This reaction can lead to the constriction of the airways, which makes it difficult or impossible to breath.

An injection of epinephrine (adrenaline) helps to open the airways and prevent an anaphylactic shock.

The EpiPen is a handheld device prefilled with epinephrine that can automatically inject the medication. The drug is normally administered into the thigh muscle, in order to stop a life-threatening allergic reaction.

If you have a severe allergy, your doctor will likely prescribe this device to you. Usually, experts recommend having EpiPen at home and at work or school. Some people prefer to have one in a purse or case, in case of an emergency.

Some parents of allergic children say that they usually keep two at home, two at the school (with the school nurse), and two in a child’s backpack.

However, the problem is that the medication has an expiration date, and it expires bery quickly. Even if it has never been used, EpiPen should be replaced in about 18 months.

What’s the Price of an Auto-Injector?


In the past years, the price of a two-pack of Mylan’s EpiPen has been raised to more than 600$, while the original price was 100$. This increase in the price left many EpiPen users angry.

The price and the release date of the new generic EpiPen has not been announced yet, but the pricing factor is very important.

If you have a health insurance, the cost of your auto-injectors can be covered by your insurer’s co-pay. However, if you have a high-deductible insurance plan or if you don’t have any insurance at all, you may need to pay thousands of dollars for epinephrine auto-injectors per year.

After the negative feedback from EpiPen users, Mylan released their own authorized generic auto-injector, which costs around $300 for a two-pack. According to the Food and Drug Administration, an authorized generic drug is an approved brand name drug which is available on the market, but without the brand name on the label.

On the other hand, a generic drug is a copy of a brand-name medication which produced by another pharmaceutical company.

Are There More Generics?


Teva Pharmaceuticals had already applied for the approval of a generic EpiPen, but it was turned down. Last year, the U.S. Food and Drug Administration released a certain guidance concerning the issue, and Teva reapplied again. Now successfully.

According to the FDA, they are especially interested in the development of generic copies of medication categorized as “complex products”. The EpiPen is an example of a complex product, as it includes a drug and a device.

It may be difficult to copy complex products, which is why there is not much generic competition on the consumer market. However, new guidance issued by the FDA can help sponsors to develop generic versions of such products more efficiently. Besides, many applications for complex generic drug approval are reviewed as a matter of priority.

High prices and the current national shortage of epinephrine auto-injectors have long been a big problem in families with food allergies and other potentially severe allergies. Experts believe the easy access and affordability of these life-saving drugs is extremely important, when it comes to effective allergy management.

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