Mylan NV has finalized a $465 million US settlement with the U.S. Justice Department, resolving claims it overcharged the government for its EpiPen emergency allergy treatment, which became the centre of a firestorm over price increases.
The U.S. Attorney's Office in Massachusetts revealed the accord on Thursday, 10 months after Mylan said it reached a deal resolving claims it misclassified the EpiPen as a generic rather than a branded product to avoid paying rebates owed to Medicaid.
"Taxpayers rightly expect companies like Mylan that receive payments from taxpayer-funded programs to scrupulously follow the rules," Acting U.S. Attorney William Weinreb said in a statement.
Mylan did admit wrongdoing in entering into the settlement.
"Bringing closure to this matter is the right course of action for Mylan and our stakeholders to allow us to move forward," Mylan Chief Executive Heather Bresch said in a statement.
The deal followed a False Claims Act whistleblower lawsuit filed by French rival Sanofi SA in 2016, two years after it first raised the matter with authorities, Weinreb's office said.
Sanofi, which in 2015 ceased marketing a rival product called Auvi-Q, will receive nearly $38.8 million as a reward from the government.
Sanofi said in a statement it considered pursuing the matter "the right thing to do." It has a separate antitrust lawsuit pending, claiming that Mylan engaged in illegal conduct to squelch competition to EpiPen.
The EpiPen, which Mylan acquired in 2007, is a handheld device that treats life-threatening allergic reactions by automatically injecting a dose of epinephrine.
Mylan came under fire last year after raising the price of a pair of EpiPens to $600, from $100 in 2008, enraging consumers and putting it in the center of the ongoing debate over the high cost of prescription medicines in the United States.
Mylan has since offered its own generic version for about $300.
The Justice Department settlement centred on claims that Mylan avoided higher rebates to state Medicaid programs by misclassifying the EpiPen as a generic product, even through the company marketed and priced it as a brand-name product.
Some members of Congress in both parties have previously criticized the $465-million settlement as too small.
A U.S. Department of Health and Human Services' Office of Inspector General analysis released in May found the U.S. government may have overpaid for EpiPens by up to $1.27 billion between 2006 and 2016.