Rea Blakey: Barr Labs sparked Prozac decision

Blakey

The Food and Drug Administration has granted approval for the sale of fluoxetine, a generic version of the popular antidepressant Prozac, which had been under patent by Eli Lilly and Co. CNN's Rea Blakey gives some perspective.

Q. What is Prozac and why is it popular?

A. Prozac is an antidepressant medication, the first in a class of drugs called selective serotonin reuptake inhibitors, or SSRIs. These SSRIs specifically target the neurotransmitter (a brain chemical) called serotonin, the lack of which is associated with depression. Unlike the previous medications designed to treat depression, Prozac doesn't cause side effects like sedation, blurred vision, constipation and dry mouth.

Q. Tell us how this battle over the Lilly patent started.

A. Barr Laboratories went after the Prozac patent starting in December of 1995. That's when Barr submitted an application for generic Prozac to the FDA, suggesting Eli Lilly patents were invalid. The issue languished in the courts until February of this year, when Eli Lilly was told its exclusive patent on Prozac would expire, except for "pediatric exclusivity" since Eli Lilly was testing the medication in children. As of Aug. 2, Eli Lilly's exclusive hold on Prozac expires. Several generic drug manufacturers filed for patents to manufacture specific dosages. Barr Laboratories won the most lucrative dosage, 20 milligrams, which represents 85 percent of Prozac sales.

Q. Why has Barr been successful in challenging the Lilly patent? Is Lilly's patent weak, as Barr says?

A. In 1984, Congress passed the Hatch-Waxman Act designed to get less expensive generic versions of drugs to the marketplace faster by allowing generic drug makers to file an application to make patent-protected drugs -- giving the big brand name drug company 45 days to sue to stop generic manufacturing. The validity of a drug's patent is up to the courts. In this case, Eli Lilly, after a hard-fought battle, lost.

Q. Does the company have a chance of stopping the release of the cheaper capsule, or is this a done deal?

A. Eli Lilly can appeal to the U.S. Supreme Court. But that does not appear likely.

Q. Will the consumer benefit from a generic Prozac capsule?

A. Absolutely, prices are expected to tumble during the next three years. The Generic Pharmaceutical Association estimates consumers will save $3 billion over the course of the next three years.

Q. Will this make consumers more reliant on anti-depressants?

A. It shouldn't. Doctors should only prescribe antidepressants when medically necessary.

Q. How have other drug giants fared after the release of generic capsules? Will Lilly still hold its own, even with the release of these generics?

A. Typically, when a generic version of a drug hits the market, retail costs tumble over time. It's not unusual to see the original brand name medication decrease in price by 60 percent to 70 percent three years after a generic version is introduced on the market. Meanwhile, Eli Lilly says it was prepared for the expiration of its exclusive Prozac patent. The company claims it will bring at least 10 new drugs onto the market during the next two to three years.