The U.S. wants Johnson & Johnson (JNJ) to pay $1 billion to settle a multi-year probe into whether the company falsely marketed the anti-psychotic Risperdal drug for unapproved uses, according to The Wall Street Journal.

The settlement would be the largest in a string of settlements related to off-label marketing of drugs in recent years and would likely have a material impact on the consumer product maker’s quarterly financial results, the Journal said, citing people close to the matter.

The investigation has been ongoing since 2004. Prosecutors have been probing whether J&J’s Janssen Pharmaceutica unit illegally promoted Risperdal for unapproved uses.

On Tuesday, the company said it set aside an unspecified amount of money for a potential settlement, noting it would likely face civil and criminal charges if it didn’t settle. J&J said resolution could have a material impact on its quarterly results.

J&J has reaped substantial profits from Risperdal, a drug used to treat schizophrenia, selling more than $2.2 billion worth in the U.S. in 2007 before the U.S. patent expired.

Follow Jennifer Booton on Twitter at @Jbooton