http://dailynews.yahoo.com/h/nm/20010802/ts/health_prozac_generics_dc.html

Thursday August 2 5:58 PM ET

Flood of Cheaper Prozac Generics Head to Stores

By Jed Seltzer and Ransdell Pierson

NEW YORK (Reuters) - A flood of cheaper, generic forms of Prozac is rolling toward U.S. drugstores, following approval by U.S. regulators on Thursday of numerous copycat versions of Eli Lilly & Co.'s blockbuster anti-depressant.

Barr Laboratories Inc. said the U.S. Food and Drug Administration (news - web sites) approved its 20-milligram capsule of fluoxetine, the chemical name for the antidepressant. The Pomona, New York-based firm expects to have 180 days as the only generic seller of that form, which accounts for about $2.2 billion of Lilly's $2.7 billion in annual sales of Prozac.

A handful of other generic firms from around the world also got in on the act, winning FDA approvals on Thursday for a variety of less popular dosages and formulations of fluoxetine.

A 30-day supply of 20 mg. Prozac capsules now costs about $80 to $95 in the United States, depending on location, but Barr's version is expected to be priced about 30 percent lower. The cost will likely come down much further in about six months, when more knockoffs of the main dosage form are permitted to be sold.

The generics will spell good news for health insurers, many of whom will no doubt try to steer patients to the cheaper copycats. And the drug will now be in somewhat closer reach for the tens of millions of Americans who lack health insurance but need relief for the highly treatable disorder, for which many people do not seek help.

Prozac, launched in the United States in 1988, was the first member of the revolutionary new class of anti-depressants called selective serotonin reuptake inhibitors (SSRIs). These drugs coax serotonin, a brain-messenger chemical, to remain in spaces surrounding nerve endings, instead of moving into nerve endings -- a process believed to stave off depression's symptoms.

DE-STIGMATIZING DEPRESSION

The drug won so much attention, and so many prescriptions, that media headlines soon proclaimed a ``Prozac generation,'' with some critics citing fears Americans would flock to the drug to solve even normal everyday problems.

Discussion of depression, long taboo, came out of the closet and became suitable cocktail conversation as the ailment became more treatable with the advent of Prozac and subsequent SSRIs, including GlaxoSmithKline's Paxil and Pfizer Inc.'s Zoloft.

Now, almost all of the top-selling antidepressants are SSRIs, but Prozac is still the best seller.

More than 38 million patients have taken Prozac since its launch and it is sold in over 100 countries.

More than 85 percent of its annual sales of $2.7 billion comes from the United States. But the cash cow will soon shrink because major branded drugs typically lose up to 80 percent of their annual revenues within a year after facing U.S. competition from generics.

Prozac was named ``product of the century'' by Fortune magazine in 1999 but its sales slipped 2 percent in 2000 -- largely due to the impact of first-time generic competition in the United Kingdom.

Prozac is also among a slate of best-selling prescription drugs expected to lose their U.S. patent protection by 2005, with generic firms expected to sweep in to claim big chunks of the medicines' combined projected sales of $40 billion.

And the rewards for generic firms could be rich.

Barr's earnings are expected to rise to $3.84 per share for the fiscal year ending in June 2002 from a projected $1.60 per share for the fiscal year that just ended, according to research firm Thomson Financial/First Call.

OTHER GENERICS JUMP ON BANDWAGON

Barr has viewed Prozac as a particularly coveted target, but other generic firms have also set their sights on the drug.

The FDA said on Thursday that a unit of Merck KGaA of Germany received approvals on the 10 mg. and 20 mg. tablet forms of Prozac, while Reddy's Laboratories of India received approval for a 40 mg. capsule version.

Those versions have been licensed for sale by Pharmaceutical Resources Inc. of Spring Valley, New York, the company said.

Teva Pharmaceutical Industries Ltd. received approval for a liquid oral formulation with a dose of 20 milligrams per 5 milliliters. Geneva Pharmaceuticals Inc., a unit of Swiss drug giant Novartis AG, received the go-ahead for a 10 mg. capsule generic version.

The other generic firms also receive 180 days of generic marketing exclusivity at the dosage forms they have had approved.

Barr and Lilly went through an exhaustive legal process in which Lilly, maintaining its patent protection ran through 2003, won its original argument in court. But a federal appeals court shocked Wall Street last August by reversing that decision, sending Lilly's stock plummeting and Barr shares soaring.

Lilly has planned to appeal the case to the U.S. Supreme Court (news - web sites), but legal experts have said the high court would be unlikely to take up the case.

For continued strong sales growth, the Indianapolis drugmaker is hoping to fall back on its highly respected drug pipeline and its portfolio of fast-growing marketed products, such as its flagship schizophrenia treatment Zyprexa and osteoporosis drug, Evista.

The firm is awaiting approval for Xigris, a potential hot-seller for a deadly blood infection syndrome called sepsis, and for the impotence pill Cialis.

-- S (S@R.Is), August 03, 2001

Answers

Indeed, a particularly ingenious New Yorker cartoon depicts a Prozac-taking Karl Marx proclaiming jubilantly, "Sure! Capitalism can work out its kinks!"

-- Smile (for@the.day), August 03, 2001.

Is this a good thing?

I've read and heard that Prozac and its family of medications can cause extreme violence in some patients, and leave others feeling like zombies. While I certainly feel for anyone plagued by depression, and believe in the dictum "if it works, use it", I can't help but wonder if anti-depressant medication isn't a band-aid approach to treating this disorder.

Many new chemicals and food additives are entering the market every month, along with other natural stressors that have always been present such as allergens. The pace of modern life may also be something that not everyone can adapt to as easily as others. Could these factors be the root cause of many of the new cases of depression diagnosed every year?

If so, and if properly diagnosed and treated, perhaps many fewer prescriptions for drugs like Prozac would be needed.

-- zipperpull (*@*.*), August 03, 2001.

What I find frightening is that sooooo many doctors are prescribing this stuff in the first visit before running any tests whatsoever and looking for an underlying cause of symptoms. What is in it for the doctors anyway, what do they get from Lilly Corp? I don't get it.

-- (cin@cin.cin), August 03, 2001.