On August 2, 2001, the courts decided to end Eli Lilly's patent on the popular antidepressant drug, Prozac. After a nearly six-year battle in the courts, the doors have opened for generic drug companies to introduce their version of the drug into the market.

Prozac was patented in 1977 by Eli Lilly and Co. and launched into the marketplace in 1987. It was the first of the selective serotonin reuptake inhibitor drugs to be produced. Serotonin, a neurotransmitter, is known to control a number of behavioral and physiological functions such as mood, emotion, sleep, and appetite. What makes Prozac more popular to other antidepressant medications is that it does not cause any side effects such as sedation, blurred vision, and dry mouth.

Barr Laboratories challenged Eli Lilly's exclusive rights to Prozac in 1995 when the company requested Food and Drug Administration (FDA) approval for a generic version of Prozac. Barr Laboratories was able to challenge Lilly's patent on Prozac because of the Hatch-Waxman Act passed by Congress in 1984. This piece of legislation made it easier for generic drug companies to obtain FDA approval for already patented drugs under the conditions that the patent for the original drug had expired, would expire, was invalid, or would not be violated by the manufacture or sale of the generic drug.

Patents grant the original companies exclusive rights to a drug for seventeen years, after which generic drug companies can challenge the patent by requesting approval for production of their own version of the drug. The brand-name companies have forty-five days to sue and stop the production of the generic. Thereafter, the decision is placed in the court's hands. After a six-year court battle, Eli Lilly lost its Prozac patent because of insufficient reasons for extension.

On August 2, 2001, four additional pharmaceutical companies, Dr. Reddy's Laboratories, Teva Pharmaceuticals, Geneva Pharmaceuticals, and Pharmaceutical Resources, received FDA approval to sell fluoxetine, the generic version of Prozac, for six months. Only Barr Laboratories was given the rights to produce the most popular form of the drug, the 20-mg capsules and has already begun production of the generic drug.

There are only minor differences between generic and name brand pharmaceutical medications. The FDA approves a generic drug if it is proven to produce the same effect as the original. The generic drug must contain the same amount of active ingredients as well as be released into the body in the same form and rate. The real difference lies in the inactive ingredients. The size, shape, and color of the generic drugs are different from those of the brand names for legal purposes, and side effects of the generic drugs may be different.

Generic drugs tend to be less expensive than their brand-name counterparts. In the case of Prozac, which was selling for $2.50 per 20-mg capsule, it is postulated that the generic versions will initially sell for $1.75 per 20-mg capsule. After the year of exclusive rights to those select generic companies has expired, production will be opened to the entire market of generic drug-makers. Then, the price is expected to drop to as little as $0.25 per capsule, making the drug much more affordable for consumers.

However, there will be the possibility that insurance companies will force the generic version of the drug onto consumers because of the lower cost. Overall, the consumers will benefit financially from the production of the generic antidepressant drug Prozac.

Peggy Gastinos is a second-year student in the GPPA-Medicine program. She is double-majoring in Biological Sciences and Psychology.