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Generics taking toll on Lipitor; World's top-selling drug is poised to be toppled from perch in 2012

Lipitor, the best-selling drug in the history of pharmaceuticals, is the blockbuster that almost wasn't.

When it was in development, the cholesterol-lowering medicine was viewed as such an also-ran it almost didn't make it into patient testing.

By the time Lipitor went on sale in early 1997, it was the fifth drug in a class called statins that lower LDL, or bad cholesterol. The class already included three blockbusters, drugs with sales of $1 billion a year or more. Normally, that would make it very tough for a latecomer to sway many doctors and patients to switch.

But a 1996 study showed Lipitor reduced bad cholesterol dramatically more than the other statins, from the very start of treatment and even more so over time. A striking graph of those results helped Lipitor sales representatives turn it into the world's best-selling drug ever, with more than $125 billion in sales over 14 1/2 years.

Nicknamed "turbostatin," Lipitor became the top-selling statin barely three years after it was launched. It has provided 20 percent to 25 percent of Pfizer Inc.'s annual revenue for years.

But after nearly a decade as the top-selling drug, Lipitor is set to be toppled in 2012 after getting its first generic rivals four weeks ago.

It will end a run not likely to be repeated.

Back in the early 1980s, the public was just starting to learn what cholesterol was. There was little evidence that controlling it with medication could be so crucial in preventing disability and early death, and the coming epidemic of obesity and diabetes in an aging population wasn't foreseen.

At the time, heart attack prevention basically amounted to telling patients to eat more oatmeal and skip the steak.

Lipitor creator Warner-Lambert, a midsized drugmaker best known for consumer health products including Listerine, Benadryl allergy pills and Halls cough drops, got a late start in what turned into a surprisingly fast-growing market.

Merck & Co. had a decade lead with Mevacor, launched in 1987. By 1994, its successor drug, Zocor, along with Bristol-Myers Squibb Co.'s Pravachol and Novartis AG's Lescol, had crowded the market.

Warner-Lambert partnered with much-larger Pfizer Inc., considered the industry's top marketer, first to help fund the expensive late-stage testing of the drug in people and then to promote Lipitor after it was launched. Pfizer bought out Warner-Lambert in 2000 to block two other companies trying to acquire it and get control of Lipitor.

In recent years, Pfizer has focused on creating other types of drugs and on another unprecedented strategy -- this one for hanging onto Lipitor revenue until June, when multiple new generic Lipitor versions will join one sold by Ranbaxy Laboratories and the authorized generic from Watson Pharmaceuticals Inc.

Pfizer is offering patients and insurance plans big discounts and rebates, including cards giving patients a $4 monthly co-payment, if they stay on Lipitor until then.

The Lipitor brand is by no means history. Its patent is still in force in many major foreign countries, and Pfizer is promoting it heavily in emerging markets such as China.

Pfizer's strategy to keep U.S. patients on Lipitor appears to be working a little better than some analysts expected: The number of Lipitor prescriptions filled in the first full week after generics arrived fell by only half.

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