In a case brought by the U.S. Attorney's Office in Philadelphia, drug company Eli Lilly & Co. is expected to agree tomorrow to pay a record $1.4 billion to settle allegations that it illegally marketed its best-selling antipsychotic drug, Zyprexa, to patients who did not need it.

The Indianapolis company and the U.S. Attorney's Office would not comment. But sources familiar with the case said the agreement, which has been expected since October, when Lilly set aside $1.4 billion to cover the cost of the litigation, was to be announced tomorrow.

The case was brought under federal whistle-blower laws by former company employees. It asserts that Lilly promoted Zyprexa for uses not approved by the U.S. Food and Drug Administration. By marketing Zyprexa heavily for such uses, such as treating dementia in the elderly and disruptive behavior in children, Lilly defrauded government programs that paid for the drug, the litigation says.

The FDA has approved Zyprexa to treat schizophrenia and bipolar disorder, also known as manic depression.

Pharmaceutical companies can promote drugs only for FDA-approved uses, but doctors are allowed to prescribe them for whatever they wish.

Lilly has been accused of encouraging the use of Zyprexa by the young and the elderly. Those two groups are especially vulnerable to the drug's risks, which include diabetes, sudden death, weight gain, heart failure and vulnerability to certain infections, including pneumonia.

Zyprexa belongs to a class of drugs known as atypical antipsychotics. They originally were thought to work better than older antipsychotics, with fewer side effects, but more recent research has shown them to be more dangerous in some cases. A report tomorrow in the New England Journal of Medicine found that the newer drugs, compared with the older ones, doubled the risk of suddenly dying from a heart problem.

Most major drug companies have been sued for promoting drugs for unapproved uses.

The stakes are high for Lilly. It sold $4.76 billion worth of Zyprexa globally last year, $2.5 billion of it in the United States. The company's full-year earnings were $2.95 billion on revenue of $18.6 billion.

If Lilly had not settled, the federal government could have banned the company from participating in federal Medicaid and Medicare programs.

"We announced on Oct. 21 that we are in advanced discussions to resolve these investigations. That is all we can say at this time," a Lilly representative said today.

The case was consolidated in Philadelphia because the U.S. Attorney's Office here has many years of experience in pharmaceutical litigation.

The Zyprexa settlement is far larger than earlier record false-claims settlements. In 2006, Tenet Healthcare Corp. paid $900 million over allegations that it had improperly billed Medicare.

In October, Lilly said it would pay $62 million to settle claims by several states over illegal marketing of Zyprexa. Pennsylvania received $2.2 million of that settlement.