Generic Prozac Coming to Stores

Prozac, the antidepressant medication that is taken by some 40 million Americans, will soon be available in a less expensive generic version.

Prozac’s manufacturer, Eli Lilly & Co., lost its patent protection on Prozac last Thursday. When it was introduced in 1988, Prozac--the first in a class of antidepressants--had a dramatic impact on how depression was treated in this country.

Barr Laboratories Inc., the Pomona, N.Y., company that will manufacture the first generic version of Prozac, said it will begin shipping the product to pharmacies this week.

It is expected that health insurers will encourage the use of generic Prozac, or fluoxetine, because it will cost less than the brand-name version. Barr Laboratories said its product will probably be available to wholesalers at 25% to 40% below the cost of Prozac, said company spokeswoman Carol Cox.

Prozac is among a class of antidepressants known as selective serotonin reuptake inhibitors. When it first went on the market, Prozac was heralded as the first treatment for depression that attempted to specifically address a biological cause of the disease. In this case, the drug treats a deficiency of a brain chemical called serotonin.

The arrival of the generic fluoxetine may finally end a long battle by Eli Lilly to extend patent protection on Prozac through 2003. Barr challenged the patent expiration date in federal court, winning a series of rulings, including a June 30 court decision that paved the way for Barr to launch its generic product.

Lilly has pledged to continue fighting the patent expiration and has asked the U.S. Supreme Court to look at the case. Such petitions are typically turned away by the high court, say legal experts.

Barr will have exclusive rights to manufacture generic Prozac in its most popular 20-milligram dosage for 180 days. Two other drug companies are expected to begin manufacturing fluoxetine after Barr’s exclusivity period expires, according to the Generic Pharmaceutical Assn. in Washington, D.C. The competition among generic versions of the drug could help lower prices even further.

Barr’s version of Prozac will contain the same active ingredients as the brand-name version and work identically, according to Cox. Eli Lilly officials have advised patients on Prozac to discuss any changes of medication with their physician. The generic version has different inactive ingredients that could affect an individual’s response.