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CNN Live At Daybreak

Generic Version of Prozac Set to be Approved

Aired August 02, 2001 - 07:35   ET

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
COLLEEN MCEDWARDS, CNN ANCHOR: Well, it looks like a generic version of Prozac is about to be approved. If it goes as planned, it would dramatically reduce the price of the popular antidepressant, but this is a complicated world of drugs and drug patents.

So let's get some help wading through all this. Rea Blakey is with us now -- Rea.

REA BLAKEY, CNN MEDICAL CORRESPONDENT: Good morning, Colleen.

Basically, the patent on Prozac is expiring today and that's being hailed as a major victory for consumers. An estimated $3 billion over the next three years are the potential savings, that according to the Generic Pharmaceutical Association.

Now as soon as the Food and Drug Administration gives the nod, which is expected today, Barr Laboratories can sell generic fluoxetine hydrochloride. That's a big word for the active compound in Prozac. Now Barr says it will sell the compound to pharmacies possibly as soon as Friday with national market penetration by next week. Barr will share the market with Eli Lilly, the makers of Prozac, for six months. After that, any pharmaceutical company can produce and sell 20 milligram tablets of fluoxetine hydrochloride. Now that could potentially take a big bite out of Prozac's $2.4 billion in annual sales.

Now Eli Lilly says it's been preparing for this day for a long time. In the words of company spokesman Ed West -- quote -- "We have a clearly articulated strategy for success in the future that has yielded the industry's strongest pipeline of new products, 10 of which will be introduced over the next two to three years."

So let's cut to the chase here. How much will the generic cost consumers? Barr says it doesn't know yet, but the Generic Pharmaceutical Association says generally during the first year generics cost 25 percent less than the brand name rivals. The discount gets deeper over time. Generics usually cost 60 to 70 percent less after three years on the market. Generics have to be the bio equivalent, meaning they have the same active ingredient as the brand name drug. They're just as safe, just as effective as the brand names, but patients should also expect the same possibility of side effects. The side effects most commonly reported by people taking Prozac include sexual dysfunction reported by 40 percent of patients, nausea, headache, insomnia, diarrhea and drowsiness. Now Prozac is one of the best selling drugs in history and Eli Lilly wants to hold on to as much of that revenue as possible. The company is now marketing a weekly Prozac pill directly to consumers. The drug company says it will save consumers 5 percent over the daily 20 milligram dosage.

So a lot is going on in this world of pharmaceuticals, Colleen.

MCEDWARDS: Sure is. Now, Rea, is Barr Laboratories the only generic company that's got a piece of this?

BLAKEY: Actually, it depends on the dosages. Barr has the most popular dosage, which is the 20 milligram, and that's about 80 percent of the Prozac market. But there are other dosages available and other smaller generic companies have a hold of those little chunks of Prozac's world as well.

MCEDWARDS: And I mean what can Eli Lilly do? Can it extend its patents or not?

BLAKEY: Eli Lilly's last resort is to try the Supreme Court, but quite frankly, this battle has drug out for a number of months and the company really does seem resigned to allowing it to proceed as anticipated today. But ,of course, that all depends on a letter from the FDA going to Barr Laboratories. But the patent for Prozac does, in fact, expire today. And unless there's some really serious last- ditch effort, it will probably become a generic drug.

MCEDWARDS: Understood.

CNN's Rea Blakey, thanks very much.

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