WebMD Medical News
Daniel J. DeNoon
Laura J. Martin, MD
Nov. 29, 2011 -- The cholesterol-lowering drug Lipitor -- the best-selling prescription drug in world history -- will be available as a generic drug beginning Nov. 30.
Lipitor's generic name is atorvastatin. Two generic drugmakers, Ranbaxy and Watson, can start selling generic atorvastatin in the U.S. right away. Due to complex generic drug laws, other generic drugmakers will have to wait 180 days, until May 2012, to offer their own generic versions of Lipitor.
But Pfizer, the giant drug company that makes Lipitor, isn't taking this lying down. With a series of unprecedented moves, Pfizer plans to make brand-name Lipitor competitive with generic atorvastatin.
What does this mean to the estimated 8.7 million U.S. patients taking Lipitor? WebMD consulted a cardiologist, a consumer health expert, and Pfizer itself to answer your questions.
Yes, says John Santa, MD, MPH, director of the Consumer Reports Health Ratings Center.
"The FDA imposes strict manufacturing parameters on the makers of generic drugs," Santa tells WebMD. "And when you look back at the manufacturing problems that have occurred, they are just as likely at a brand-name plant as at a generic plant."
Nearly all the time, generic drugs cost less than brand-name drugs.
Until May 2012, there will be only two makers of generic Lipitor. One will be Ranbaxy Pharmaceuticals, the first company to successfully challenge Pfizer's Lipitor patent.
The other will be Watson Pharmaceuticals. Watson has made a deal with Pfizer to distribute an "authorized generic" that actually is made by Pfizer itself, according to Pfizer spokesman MacKay Jimeson.
"The two companies making generic atorvastatin are good companies with good track records," Santa says.
Yes. Lipitor belongs to a class of drugs called statins. All statin drugs are available only by prescription. These drugs include:
There is media speculation that Pfizer intends to ask the FDA to approve an over-the-counter version of Lipitor in the not-too-distant future. But it's not clear that will happen. The FDA in 2008 rejected Merck's application to sell over-the-counter Mevacor.
Yes. Jimeson says the company wants to make brand-name Lipitor available to customers at or below the cost of generic atorvastatin for at least the next six months.
"To create the most options for patients and lower costs during the 180-day exclusivity period, we are offering Lipitor at or below the cost of a generic," Jimeson tells WebMD. "This ensures access to this medication in a time of rapid change in an unpredictable marketplace."
What will happen after May 2012, however, is anybody's guess. Until then, however, Pfizer is making brand-name Lipitor very attractive.
In a controversial move, the company made a deal with pharmaceutical benefit managers -- the middlemen between pharmacies and payers (insurance companies and Medicare).
In return for getting Lipitor at a discount, the companies would offer the brand-name drug for about a $10 co-payment. That's the typical co-payment for a generic drug. Co-pays for brand-name Lipitor currently run about $25 or more. The downside: Some participating pharmacies will not offer generic Lipitor.
But consumers can do even better than that. Pfizer is offering a "Lipitor for You" program that lets qualified patients get the drug for as little as $4 per month. The offer is good through Dec. 31, 2012. It's not available to people who get their drugs through federal or state insurance programs -- including Medicare and Medicaid -- or whose private insurance pays the full cost of their medicines.
Even so, Santa of Consumer Reports warns patients to keep an eye on the pharmaceutical giant.
"Pfizer has made $100 billion on Lipitor. It has received a very great reward for its work developing and marketing the drug," he says. "Now the consumers are supposed to get the benefit. Let us all hope this happens. If it does not, it says something about our system."
Online pharmacies already are offering generic Lipitor. One is selling a 30-day supply of the 40 mg atorvastatin pills for $99.
Of course, people with health insurance that covers prescription drugs will pay much less. And for at least the rest of the year, those in the "Lipitor for You" program will pay even less.
Maybe. Lipitor didn't get to be the best-selling prescription drug of all time without what Santa calls "brilliant marketing."
"Lipitor has been marketed so heavily, this may be a good time to ask your doctor about the best new evidence about statins," Santa says. "For example, if you are a woman at low risk of heart disease and only have a small elevation in LDL cholesterol, the evidence does not support lifetime treatment with statin drugs."
Cardiologist Robert Ostfeld, MD, associate professor of clinical medicine at Montefiore Medical Center, New York, agrees.
"Whether to continue to take statin drugs should be regularly assessed by one's doctor," Ostfeld tells WebMD. "Ideally one should get to one's cholesterol goal by healthy lifestyle. So it is possible for you to reduce your statin dose or even eliminate need for the drug by eating healthy foods and getting regular exercise."
On the other hand, your doctor might find you need to increase your statin dose or even switch to a more potent statin.
Everybody should keep their cholesterol under control. Statin drugs such as Lipitor are powerful cholesterol-lowering medicines.
But for most people, statins are not the best way to lower cholesterol, cardiologist Ostfeld says.
"Far and away the most important thing is that you follow a healthy lifestyle," he says. "That includes a whole-foods, plant-based diet, and regular exercise."
Statin drugs are for people who, despite following a healthy lifestyle, still need help lowering their cholesterol.
They are also for people with symptoms of cholesterol blockage of the heart or arteries, who need immediate cholesterol lowering. These symptoms include:
A person with such symptoms should seek medical care.
SOURCES:Robert Ostfeld, MD, associate professor of clinical medicine, Montefiore Medical Center, New York.John Santa, MD, MPH, director, Consumer Reports Health Ratings Center.MacKay Jimeson, Pfizer Inc.Pfizer web site.Watson Pharmaceuticals web site.Ranbaxy Pharmaceuticals web site.HealthWarehouse web site.Consumer Reports web site.
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