Irish pharmaceutical manufacturer Elan Corporation, PLC, its U.S. subsidiary, Elan Pharmaceuticals, Inc., and Japanese drug manufacturer Eisai, Inc., have all agreed to pay a total for $214.5 million to resolve allegations of off-label promotion of Zonegran, an epilepsy drug.

Elan Pharmaceuticals agreed to plead guilty to misbranding Zonegran, which was approved by the FDA in concert with other drugs to treat partial seizures in adults over age 16 only. Elan promoted the drug for a wide variety of unapproved uses including mood stabilization for mania and bipolar disorder, migraine headaches, chronic daily headaches, eating disorders, obesity control, and movement disorders. Elan also promoted Zonegran for a variety of seizures in children under the age of 16 and as the sole drug needed in treatment rather than in combination with others.

In addition, Elan’s off-label marketing targeted non-epilepsy prescribers and paid illegal kickbacks to physicians to encourage them to prescribe Zonegran for off-label uses.

Elan Corporation and Elan Pharmaceuticals will pay over $203.5 million to resolve these claims. Of this, a whistleblower in this case will receive payments totaling more than $10 million from the federal share of the civil recovery. Elan agreed to enter into a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services. Eisai, Inc., has already paid $11 million as a result of their alleged off-label marketing of Zonegran.