Mylan has agreed to pay $465m to the US Department of Justice (DOJ) and other government agencies to settle Medicaid claims over its EpiPen auto injector.
The firm has reached the settlement to resolve questions, which were raised about the classification of EpiPen auto-injector and EpiPen Jr auto injector for purposes of the Medicaid Drug Rebate Program.
The Centers for Medicaid and Medicare Services (CMS) classified EpiPen auto-injector as a non-innovator drug since before Mylan acquired the product in 2007.
According to Mylan, the settlement terms provide for resolution of all potential rebate liability claims by federal and state governments as to whether the product should have been classified as an innovator drug for CMS purposes and subject to a higher rebate formula.
In addition, the firm intends to enter into a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services in connection with the settlement.
Mylan CEO Heather Bresch said: "This agreement is another important step in Mylan's efforts to move forward and bring resolution to all EpiPen Auto-Injector related matters.
“The agreement is in addition to the significant steps Mylan has taken in relation to EpiPen Auto-Injector over the past several weeks, including the unprecedented, pending launch of a generic version of EpiPen Auto-Injector and expansion of our patient access programs for this product.”