FDA Approves Generic Epipen; Expected to Help Costs and Shortages


Earlier this month, the FDA approved the first generic version of Epipens. While Mylan, the manufacturer of Epipen, offers off-brand auto injectors, it has yet to have true competition. Our Malique Rankin explains how a generic can help with prices, and shortages.

For patients with life-threatening allergies, doctors prescribe them one of four epinephrine auto-injectors:
Epipen, off-brand Epipen, Adrenaclick or Auvi-Q

Now that Teva Pharmaceuticals has a green light from the FDA, for the first time, Mylan will have to compete with pricing.
Teva’s product is considered the first generic because the auto-injector will be identical to Mylan’s.

Nana Fenny; Sanford Allergist: “This is very important. It’s going to be about half the price, or even less.”

Nana Fenny is an allergist at Sanford. She says the high costs of Epipens have left her with difficult advice to give patients that can’t afford the price.

Nana Fenny; Sanford Allergist: “And I always would end up saying, its better for you to have an expired Epipen than not to have it at all”

Kelsey Pierson’s 9 month-old is one of Dr. Fenny’s patients. Fortunately, insurance helps her costs.
Pierson believes epinephrine should be more affordable, because without it, the result could be fatal.

Kelsey Pierson; Child has life-threatening allergies:”It’s really important. If she gets into contact with something she shouldn’t have, she could go into anaphylactic shock. If we didn’t have it, she could die.”

For those with several severe allergies, having epinephrine on-hand at all times is a necessity.

Kelsey Pierson; Child has life-threatening allergies:”She has a severe nut allergy, and she’s also allergic to milk and soy.”

Nana Fenny; Sanford Allergist: “There was a price spike to about $650 for a duel pack in 2016. That was extremely restrictive, because the shelf life of epipen is only about 20 months.”

The FDA says patients can expect a lower-cost option, as well as another approved product to help protect against potential drug shortages.
Teva Pharmaceuticals will be launching their new product in a few months.

FDA has had epinephrine and their auto-injectors listed as “in shortage” since May.

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