Sales of Lipitor, the top-selling drug in history, have leveled off after a steep plunge following the start of U.S. generic competition.
New figures from data firm IMS Health show that at the end of December, sales of Pfizer Inc.'s Lipitor were at just above a 37 percent market share.
Two new generic versions of the cholesterol-lowering drug came on the market at the beginning of December, and in the first full week of the month they had siphoned off a combined 59 percent of sales. By the last week of December, atorvastatin pills from Ranbaxy Laboratories Ltd. and the authorized generic from Watson Pharmaceuticals Inc. _ manufactured by Pfizer and marketed by Watson _ only picked up another 4 percent between them.
That's because Pfizer is fighting hard to retain branded Lipitor sales, with big discounts to patients and insurers.
Lipitor lost U.S. patent protection on Nov. 30.
Pfizer, the world's largest drugmaker, has been offering patients discount cards that give them a $4 copayment _ less than the copay for all but the most popular generics _ if they keep taking Lipitor rather than defecting to a cheaper generic version.
New York-based Pfizer also has been giving insurance plans that agree to only cover brand-name Lipitor for the time being the difference between what they had been paying for the brand and what they would pay for cheaper generics.
Until recently, Pfizer has been heavily advertising the copay program, called "Lipitor For You," and is still running some ads. Usually drugmakers end all advertising of brands well before the first generic competition arrives.
But with Lipitor generating about $7.9 billion in annual sales in the U.S. and nearly $11 billion worldwide _about 16 percent of Pfizer's annual revenue _ the company elected to pull out all the stops to hang onto sales for as long as possible.
The unprecedented strategy, closely watched because most other big drugmakers have their own blockbusters facing generic competition in the next couple of years, appears to be paying off. Normally, sales of a brand name drug continue to fall over the weeks and months after the start of generic competition.
"It's been pretty stable after the first few weeks," Michael Kleinrock, research director at the IMS Institute for Healthcare Informatics, told The Associated Press. "Normally you see a free fall."
"It's still early days," he added.
Because the arrival of generics brought a chance for health insurers, plan sponsors and patients to save significant money, insurers had prepared long ago to automatically switch all their patients on Lipitor to generics. Pfizer's strategy upended that.
IMS data show that U.S. patients were filling about 865,000 Lipitor prescriptions a week in November. That plunged by more than 55 percent, to about 397,000 prescriptions, in the first full week of December. But in the last three weeks of December, patients were filling about 350,000 brand-name Lipitor prescriptions a week. The number was down a bit for the week ended Dec. 30 because patient visits to doctors, and prescription sales as well, dropped during that holiday week.
Of the two generic versions, Ranbaxy's has grabbed greater market share, about 35 percent of atorvastatin prescriptions to Watson's 27 percent and Pfizer's 37 percent.
Ranbaxy spokesman Chuck Caprariello said the company is "delighted that we are able to market atorvastatin and we anticipate increased market share over time."
Ranbaxy, India's largest maker of generic drugs, did not get permission from the Food and Drug Administration to sell its generic until the night of Nov. 30. That was because long-standing manufacturing issues at some Ranbaxy factories led the FDA to block shipments of many Ranbaxy drugs to the U.S. Ranbaxy, which has been working to resolve those issues, got FDA permission to make its atorvastatin at a New Brunswick, N.J., factory.
Watson spokesman Charlie Mayr said IMS data doesn't capture all sales, and he believes his company is splitting the generic sales fairly evenly with Ranbaxy. Watson is based in Parsippany, N.J.
Pfizer spokesman MacKay Jimeson wrote in an email response to questions that "Lipitor continues to meet our expectations.
"Enrollment in the Lipitor For You program has been in line with our expectations, as we expect the majority of patients will be automatically switched to a generic," he wrote. "Our goals are to support patient choice."
Mayr said his company expected that "Pfizer's very aggressive strategy would retain about 40 percent of the overall market. The fact that it's below 40 demonstrates that they haven't been quite as successful as we had anticipated."
Sanford Bernstein analyst Dr. Tim Anderson has estimated that for a 90-day supply of Lipitor, even after paying the rebates to insurers and patients, Pfizer still can make a profit of roughly $100, compared with about $225 before generic competition.
That math all changes come this June, when additional generic companies will be allowed to enter the market. The increased competition will send prices for atorvastatin plunging, to as little as 25 percent of the original Lipitor price, about $115 to $160 per month, depending on dosage. It's unlikely that Pfizer would then be able to offer discounts big enough to still make a profit.
"This will be an all-generic market" at that point, Mayr predicted.
Kleinrock, of IMS, said that having a brand-name company competing with generics, as Pfizer is doing now, should push down prices for all the versions.
"It's clear that every company's watching to see if this works," he said, because up till now brand-name drugmakers have accepted rapid loss of sales of their blockbusters as inevitable.
"This could have repercussions," he said, if other brand-name companies decide to follow suit.