Generic Prozac To Hit Shelves Soon
Court ruling against Lilly may save consumers 30%
THURSDAY, May 31, 2001 (HealthDayNews) -- Treating depression should cost less this summer thanks to a court ruling Wednesday that gives a drugmaker the right to sell a generic version of Prozac.
A three-judge panel of the U.S. Circuit Court of Appeals rejected Eli Lilly's argument defending the last patent of its blockbuster antidepressant that was set to expire in December 2003. The decision clears the way for Barr Laboratories of Pomona, N.Y., to begin selling its own version of the drug, fluoxetine hydrochloride (the name of the active ingredient in Prozac), which it hopes to do Aug. 3. That's the day after Lilly's exclusive license for pediatric use of Prozac ends. Lilly took out its first patent on Prozac in 1974, and over the years filed for five more, thereby extending exclusivity for the company.
Last August, the appeals court found that Lilly had illegally held its December 2003 patent for Prozac because it overlapped use on one of its previous patent. Lilly called for a review of that decision, but the latest ruling again concludes, though by different reasoning, that the 2003 protection was improper.
"We disagree with the appellate court's revised ruling as strongly as we disagreed with the original decision of the court," Rebecca O. Kendall, Lilly's general counsel, says in a statement. "We will continue to vigorously pursue the legal options available to us by now seeking a legal review of this decision." Kendall says those options include a new hearing or even an appeal to the U.S. Supreme Court.
But Carol Cox, director of corporate communications for Barr, calls the decision "a huge victory" for the company and patients. "You'll probably see higher utilization and lower costs," says Cox, who predicts that consumers, insurers and retailers will save billions of dollars once other drugmakers enter the market for the knockoff Prozac.
Barr, which has tentative approval from the U.S. Food and Drug Administration to sell fluoxetine once the patent issues are resolved, will have a 180-day window to be the exclusive producer of generic Prozac. During that time, the price of the drug could be about 30 percent less than for the brand-name variety, Cox says.
A 30-day supply of 20-milligram Prozac tablets -- the dosage Barr will introduce -- costs about $75 at drugstore.com. Assuming a 30-percent discount, out-of-pocket savings would be about $22.50 for a monthly supply.
After the initial six-month period other companies can start selling fluoxetine, and Cox says she knows of eight or nine firms already lined up to do so. That should drive the price of the drug down even more sharply, experts say.
According to Lilly, Prozac, a selective serotonin reuptake inhibitor, is the world's most popular brand-name antidepressant. It has some 40 million users worldwide, including more than 22 million in the United States alone. The drug has become a fixture in the popular culture, spawning books and jokes about its powers, abuse and omnipresence.
Lilly recently launched a weekly form of Prozac, a formulation that has its own patent protection. The drug has also been approved for the treatment of severe PMS, for which it is being marketed under the name Sarafem.
Brett Kay, director of food and health policy at the National Consumers League, a nonprofit consumer advocacy group in Washington, D.C., calls the court ruling "good news" for people who take antidepressants. While the introduction of generic drugs will likely make only a small difference in the wallets of patients with a prescription drug benefit, those who pay out of pocket could see significant savings, says Kay.
The group supports the Schumer-McCain Act, introduced earlier this year, that would close loopholes in the 1984 Drug Price Competition and Patent Restoration Act that allow drugmakers to extend their patents.
What To Do
For more on depression, try the Depression and Related Affective Disorders Association.
Read other HealthDay articles about Prozac.