Teva Pharmaceutical Industries has introduced limited doses of the FDA-approved generic version of EpiPen (epinephrine injection, USP) auto-Injector, 0.3mg, in the US.
Image: Teva has launched generic version of EpiPen auto-injector in US. Photo: courtesy of Baitong333 / FreeDigitalPhotos.net.
Teva’s generic version of the EpiPen Jr (epinephrine injection, USP) Auto-Injector, 0.15 mg, and an additional supply of Teva’s generic version of the EpiPen (epinephrine injection, USP) auto-Injector, 0.3mg is expected in 2019.
The publically-available Wholesale Acquisition Cost (WAC)2 for the product is $300.
Teva North America commercial head and EVP Brendan O’Grady said: “We’re pleased to provide access to Epinephrine Injection (Auto-Injector) for patients who may experience life-threatening allergic emergencies and we’re fully dedicated toward ensuring additional supply in 2019.”
With over 550 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market and holds the leading position in first-to-file opportunities, with over 100 pending first-to-files in the US. Currently, one in seven generic prescriptions dispensed in the US is filled with a Teva generic product.
Epinephrine Injection (Auto-Injector) is a prescription medicine in a disposable, prefilled automatic injection device (auto-injector) used to treat life-threatening, allergic emergencies including anaphylaxis in people who are at risk for or have a history of serious allergic emergencies. Each device contains a single dose of epinephrine.
Epinephrine Injection (Auto-Injector) is for immediate self (or caregiver) administration and does not take the place of emergency medical care. You should get emergency help right away after using Epinephrine Injection (Auto-Injector).
Anaphylaxis can be life-threatening, can happen within minutes, and can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or unknown causes. Use Epinephrine Injection (Auto-Injector) right away when you have an allergic emergency (anaphylaxis).
Get emergency medical help right away. You may need further medical attention. You may need to use a second Epinephrine Injection (Auto-Injector) if symptoms continue or recur. Only a healthcare provider should give additional doses of epinephrine if you need more than 2 injections for a single anaphylaxis episode.
Epinephrine Injection (Auto-Injector) should only be injected into the middle of your outer thigh (upper leg) through clothing if necessary.
Do not inject the Epinephrine Injection (Auto-Injector) into your: veins, buttocks, fingers, toes, hands, or feet. If you inject a young child with Epinephrine Injection (Auto-Injector), hold their leg firmly in place before and during the injection to prevent injuries.
If you accidentally inject Epinephrine Injection (Auto-Injector) into any other part of your body, go to the nearest emergency room right away. Tell the healthcare provider where on your body you received the accidental injection.
Rarely, patients who have used Epinephrine Injection (Auto-Injector) may develop infections at the injection site within a few days of an injection.
Some of these infections can be serious. Call your healthcare provider 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.
Teva Pharmaceutical Industries is a global leader in generic medicines, with innovative treatments in select areas, including CNS, pain and respiratory. We deliver high-quality generic products and medicines in nearly every therapeutic area to address unmet patient needs.
Source: Company Press Release