Mylan Launches the First Generic for EpiPen® (epinephrine injection, USP) Auto-Injector as an Authorized Generic

The authorized generic for EpiPen® (epinephrine injection, USP) Auto-Injector will soon be available to patients in the U.S., as announced in the Dec. 16, 2016, press release.

Mylan is offering the generic product at a wholesale acquisition cost (WAC) of $300 per two-pack, which is more than 50% lower than the WAC of EpiPen Auto-Injector. At this price point, the authorized generic has the lowest WAC of all epinephrine auto-injectors on the U.S. market. Releasing the authorized generic is the most meaningful way to help reduce costs for patients and families and the best way to help ensure that cost savings are passed on to the patient, while assuring access to the product.

More information on Mylan’s Epinephrine Injection, USP Auto-Injector and our patient resources can be found at MyGenericEAI.com and Mylan.com/epipenaccess.

Following are a few frequently asked questions.

  1. Is the authorized generic for EpiPen Auto-Injector the exact same drug in the exact same auto-injector? Are there any differences between the generic and the brand name version?
    According to the Food and Drug Administration (FDA), the only difference between an authorized generic and a brand name product is the label. They are exactly the same, except the authorized generic does not bear the branded name. A company can create and sell an authorized generic of a branded product it already produces under a previously approved New Drug Application.

    Mylan’s Epinephrine Injection, USP Auto-Injector is the same as EpiPen Auto-Injector, including dosage, administration and formulation. The only difference is the label, which does not include the EpiPen® brand name.

  2. What are the anticipated savings for consumers who purchase the authorized generic?
    Mylan offers the authorized generic at a wholesale acquisition cost of $300, which is more than 50% lower than EpiPen Auto-Injector. Mylan is taking steps to help ensure that it will be available to consumers at the lowest possible price, including a Patient Access Program for qualified patients. The final retail cost to the patient for either EpiPen Auto-Injector or the authorized generic will be dependent upon their insurance and any mark-ups within the supply chain.

  3. Is the authorized generic available now? How do I receive the authorized generic?
    The product will soon be available in local retail pharmacies. For patients who would otherwise need to pay more than $300 to obtain the product from their local retail pharmacy, Mylan also offers a Patient Access Program, which provides the option to purchase the authorized generic at $300 per two-pack through a third-party pharmacy network. Patients can learn more about this program by calling 844-357-3699.

  4. Why would patients pay more for the branded EpiPen Auto-Injector if the generic is the same medicine and device?
    Depending on several factors – for example, a patient’s health insurance – the out-of-pocket cost for EpiPen Auto-Injector may be a more affordable option. Mylan continues to offer both options for patients so that they can work with their healthcare professional to determine the best, most affordable option for them.  Our goal is to enable everyone who needs EpiPen Auto-Injector to have access to treatment at the lowest possible price.  Patients need to evaluate which is the most cost-effective option for them based on their individual circumstances, including their personal insurance, in consultation with their pharmacist.

  5. Does Mylan offer a copay program for the authorized generic for EpiPen Auto-Injector?
    Yes.  Mylan offers a savings card for the authorized generic for eligible patients with commercial health insurance. This provides up to $25 off the consumer’s out-of-pocket cost for each two-pack of the authorized generic, up to three two-packs per prescription.

    Mylan will also continue to maintain the My EpiPen Savings Card® for EpiPen Auto-Injector.  You can find information on the updated My EpiPen Savings Card at epipen.com/savings.


Indications  

Epinephrine Injection, USP Auto-Injectors are for the emergency treatment of life-threatening allergic reactions (anaphylaxis) caused by allergens, exercise, or unknown triggers; and for people who are at increased risk for these reactions. Epinephrine Injection, USP Auto-Injectors are intended for immediate administration as emergency supportive therapy only. Seek immediate emergency medical help right away.

Important Safety Information  

Use Epinephrine Injection, USP 0.3 mg or Epinephrine Injection, USP 0.15 mg Auto-Injectors right away when you have an allergic emergency (anaphylaxis). Get emergency medical help right away.  You may need further medical attention.  Only a healthcare professional should give additional doses of epinephrine if you need more than two injections for a single anaphylactic episode. Epinephrine Injection, USP Auto-Injector should only be injected into the middle of your outer thigh (upper leg), through clothing if necessary. Do not inject into your veins, buttocks, fingers, toes, hands or feet. Hold the leg of young children firmly in place before and during injection to prevent injuries. In case of accidental injection, please seek immediate medical treatment.   

Rarely, patients who have used Epinephrine Injection, USP Auto-Injector may develop an infection at the injection site within a few days. Some of these infections can be serious. Call your healthcare professional right away if you have any of the following at an injection site: redness that does not go away, swelling, tenderness, or the area feels warm to the touch.

Tell your healthcare professional about all of your medical conditions, especially if you have asthma, a history of depression, thyroid problems, Parkinson’s disease, diabetes, high blood pressure or heart problems, have any other medical conditions, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Be sure to also tell your healthcare professional all the medicines you take, especially medicines for asthma. If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have longer lasting side effects when you use Epinephrine Injection, USP Auto-Injector.   

Common side effects include fast, irregular or “pounding” heartbeat, sweating, nausea or vomiting, breathing problems, paleness, dizziness, weakness, shakiness, headache, feelings of over excitement, nervousness or anxiety. These side effects usually go away quickly if you lie down and rest. Tell your healthcare professional if you have any side effect that bothers you or that does not go away.  

Please see the full Prescribing Information and Patient Information.  

You are encouraged to report negative side effects of prescription drugs to the FDA.  Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For additional information, please contact us at 800-395-3376.

EpiPen® is a registered trademark owned by Mylan Inc.

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