FDA Approves Generic Version of EpiPen

People with potentially life-threatening allergies got some welcome news last week when the Food and Drug Administration (FDA) approved a generic version of EpiPen, an auto-injector that contains the drug epinephrine to treat severe allergic reactions.

The launch of the device from Teva Pharmaceuticals USA is still months away, but it is expected to ease concerns about potential supply shortages and offer a less expensive alternative for users.

A two-pack of the Mylan brand EpiPen retails for $600. In May, the FDA had put Mylan's EpiPens on a list of drug shortages.

“Any measures that can improve the availability and costs of these medications is a real benefit for our patients,” says Robert Wood, MD, president of the American Academy of Allergy, Asthma & Immunology and a professor of pediatrics at the Johns Hopkins University School of Medicine in Baltimore.

Devices Are Used by Millions

The EpiPen is a handheld automatic injector prefilled with the drug epinephrine, which is administered into the thigh to quickly reverse a severe allergic reaction.

Millions of people in the United States live with allergies to certain medication, foods, latex, or insect stings. A severe allergic reaction (anaphylaxis) constricts the airways and impedes breathing. The epinephrine opens the airways and can prevent the body from going into shock.

Physicians generally recommend that people with severe allergies keep a device at home and at work or school. Many people also always keep one with them in a case or purse.

Even if they have never been used, the devices expire within about 18 months and need to be replaced.

Elizabeth Diament of Silver Spring, Maryland, whose 13-year-old son, Josh, has a nut allergy, says, “I like to have two at home, two in his backpack, and two with the school nurse, and they expire very quickly.”

Pricing Is a Big Issue

Teva has not yet announced when the new generic device will be available or what it will cost. Price is important. The price of the currently available EpiPens has soared 300 percent in the past decade.

People with health insurance can often get auto-injectors for the cost of their insurer’s co-pay. But for people who are uninsured or who have a high-deductible health insurance plan, the devices can cost them thousands of dollars per year.

Mylan released its own lower-cost "authorized generic" last year at half the price (about $300 for a two-pack). According to the FDA, the term authorized generic drug is used to describe an approved brand name drug that is marketed without the brand name on its label. A generic drug, on the other hand, is a copy of a brand-name drug made by a company other than the company that makes the brand-name drug.

There are two other brands of auto-injectable epinephrine on the market: Adrenaclick and Auvi-Q.

A Commitment to Generics

Teva was turned down for a generic version of the EpiPen two years ago, but it reapplied after the FDA issued some guidance last year.

“We’re especially committed to the development of generic copies of complex products,” said FDA commissioner Scott Gottlieb in a statement. The EpiPen is categorized as a “complex product” because it combines a device and a drug.

“These products can be hard to copy, and therefore sometimes don’t face timely generic competition once patents and exclusivities are no longer a block to approval,” Gottlieb said. “We’re advancing new guidance for sponsors to make the development of generic versions of complex products more efficient, and we’re prioritizing review of many complex generic drug applications.”

Lisa Gable, CEO of the McLean, Virginia–based advocacy group Food Allergy Research & Education (FARE), says that “for far too long, families managing food allergies have struggled to afford epinephrine auto-injectors, or even to fill their prescriptions, given the current national shortage. It is critically important that this life-saving medication is easily accessible and affordable for anyone at risk for anaphylaxis.”

If you have difficulty finding currently available epinephrine auto-injectors, FARE offers the following advice on its website:

  • Visit healthmart.com to find independent pharmacies that may have the device in stock.
  • If you can’t find the device brand that you normally use, discuss other options with your doctor.

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