Court Grants Organon's Remeron Settlement Preliminary Approval

A federal court has issued preliminary approval for a $36 million settlement agreement that would resolve allegations that New Jersey-based drugmaker Organon USA engaged in anticompetitive acts related to its depression drug Remeron.

Organon inked the settlement agreement with federal prosecutors last fall to resolve claims brought by nine large grocery-store pharmacies, as well as indirect purchaser claims brought by state attorneys general. The company was accused of making a fraudulent misrepresentation to the FDA about the claims of a patent listed in the agency's Orange Book to delay the introduction of generic competition to Remeron (mirtazapine) by approximately eight months.

Under the terms of the settlement agreement, Organon will pay $36 million, a portion of which will be used to reimburse consumers who purchased the drug. Organon also agreed to an injunction that will require it to make timely listings of patents and prohibits it from submitting misleading or false information to the FDA.

The agreement recently received preliminary approval from the U.S. District Court for the District of New Jersey. The court's approval clears the way for attorneys general to implement a claims administration process for consumers who purchased Remeron or a generic equivalent between June 15, 2001, and the date of the settlement agreement. A fairness hearing on the final approval of the settlement will be held June 28.