Mylan has announced that its U.S. subsidiary will launch the first generic to EpiPen Auto-Injector (epinephrine injection, USP) at a list price of $300 per generic EpiPen two-pack carton, which represents a discount of more than 50% to the Mylan list price, or wholesale acquisition cost (WAC), of the branded medicine.

The authorized generic will be identical to the branded product, including device functionality and drug formulation. Mylan expects to launch the product in several weeks, pending completion of labeling revisions. Upon launch, the product will be available as a two-pack carton in both 0.15mg and 0.30mg strengths. Mylan also intends to continue to market and distribute branded EpiPen.

Mylan CEO Heather Bresch commented, "We understand the deep frustration and concerns associated with the cost of EpiPen to the patient, and have always shared the public's desire to ensure that this important product be accessible to anyone who needs it. Our decision to launch a generic alternative to EpiPen is an extraordinary commercial response, which required the cooperation of our partner. However, because of the complexity and opaqueness of today's branded pharmaceutical supply chain and the increased shifting of costs to patients as a result of high deductible health plans, we determined that bypassing the brand system in this case and offering an additional alternative was the best option. Generic drugs have a long, proven track record of delivering significant savings to both patients and the overall healthcare system. The launch of a generic EpiPen, which follows the steps we took last week on the brand to immediately reduce patients' out-of-pocket costs, will offer a long-term solution to further reduce costs and ease the burden and complexity of the process on the patient."

Bresch continued, "Ensuring access to medicine is absolutely the core of Mylan's mission and has been since our founding 55 years ago. Mylan currently markets approximately 600 products in the U.S., saving our healthcare system hundreds of millions of dollars annually. We also are committed partners to the allergy community and take our responsibilities to serving these patients very seriously. Today's action further demonstrates this commitment."

To enhance affordability for the broadest patient population possible, both the augmented patient assistance program and the $300 savings card announced last week will remain in place for the brand product. The $300 My EpiPen Savings Card acts as cash at the pharmacy and is available at epipen.com/savings. People interested in learning more about the patient assistance program should contact Mylan's Customer Relations team at 800-395-3376. Mylan also will continue its EpiPen4Schools program.

In addition, Mylan intends to initiate a direct ship program in conjunction with the launch of the generic at the $300 generic list price. Mylan also continues to fight for enhanced access to epinephrine auto-injectors through other measures, such as inclusion of the product on the federal and private insurance preventive drug lists, which could potentially eliminate all co-pays.

Importantly, Mylan remains fully committed to continuing to meet the needs of this under-served patient population. This includes investing in education and awareness about anaphylaxis, a life-threatening allergic reaction. These efforts have proven vital to ensuring patients are aware of their risk, prepared in the event anaphylaxis occurs, and have access to epinephrine auto-injectors whenever and wherever they need them, at an affordable cost.