(Phoenix, Ariz. – October 20, 2004) Attorney General Terry Goddard today announced the settlement with drug maker Organon USA, Inc. and its parent company Akzo Nobel N.V. for misleading the US Food and Drug Administration about the scope of a new “combination therapy” patent it had received allowing the company to extend its monopoly over the antidepressant drug, Remeron and its generic equivalent.
Goddard joined all 50 U.S State and territory Attorneys General after a 10-month investigation resulted in a complaint filed alleging that Organon delayed listing the patent with the FDA in an effort to delay the availability of lower-cost generic substitutes. The complaint alleges that this delay resulted in higher prices to those who paid for the drug. Remeron is Organon’s top-selling drug, with annual sales in excess of $400 million.
The preliminary nationwide settlement, which must be approved by the U.S. District Court of New Jersey, includes $36 million for consumers, state purchasers, and other end payerswho purchased Remeron between June 2001 and present. The settlement also includes a requirement that Organon make timely listings of patents, and prohibits Organon from submitting false or misleading listing information to the FDA. A plan to allocate the settlement funds will be filed with the court at a future date.
“The defendants in this case tried to stifle competition and prevent consumers from having access to low-cost generic equivalents of this drug,” Goddard said.
Arizona consumers who purchased Remeron between June 15, 2001 and present will be able to submit claims for reimbursement once the court approves the settlement. A process for claims will be implemented once the settlement is given court approval. Arizona will also be among states receiving monies for damages incurred by state agencies that purchased Remeron during the same time period.