Netherlands-based Mylan has announced that its United States subsidiary will launch the first generic version of the EpiPen autoinjector (epinephrine injection, USP) at a list price of $300 per two-pack carton, which represents a discount of more than 50% off the wholesale acquisition cost of the branded product. The authorized generic will be identical to the branded product, including device functionality and drug formulation, according to the company.
Mylan expects to launch the generic product in several weeks, pending the completion of labeling revisions. Upon launch, the product will be available as a two-pack carton in both 0.15-mg and 0.30-mg strengths. Mylan also intends to continue to market and distribute the branded EpiPen. Further, the company intends to initiate a direct-ship program in conjunction with the launch of the generic at the $300 list price.
EpiPen and EpiPen Jr autoinjectors are used for the emergency treatment of life-threatening allergic reactions. Each EpiPen 2-Pak and EpiPen Jr 2-Pak contains two single autoinjectors, instructions for use, and a training device (with no drug product or needle) to help patients become familiar with the administration technique. The EpiPen autoinjector should be administered immediately at the first sign of an anaphylactic reaction. The product is not a substitute for emergency medical treatment.
Mylan is the latest company to be caught up in the growing anger at hefty drug price increases. Valeant Pharmaceuticals International and Turing Pharmaceuticals have both been publicly excoriated for similar price hikes.
The FDA rejected Adamis Pharmaceuticals Corp.’s rival treatment to EpiPen in June. Sanofi has pulled its device from the market, and Teva Pharmaceutical Industries was forced to delay the launch of its version, leaving Mylan an open field.