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FAQ: Generic Lipitor

Lipitor Goes Generic: What It Means for You
By
WebMD Health News
Reviewed by 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.

Will generic Lipitor be the same as brand-name Lipitor?

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.

Will I still need a prescription to get generic Lipitor?

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.

Can I still get brand-name Lipitor?

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."

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Congratulations! Your total cholesterol level is in the Desirable range, and your level of "bad" LDL cholesterol is optimal.

Congratulations! Your total cholesterol level is in the Desirable range, and your level of "bad" LDL cholesterol is near optimal.

Your total cholesterol level is in the Desirable range, but your level of "bad" LDL cholesterol is borderline high. If your LDL goes higher, your total cholesterol level could become Borderline High. Consider reducing the amount of foods you eat with saturated fats and increasing physical activity. If you get more exercise, your level of "good" HDL cholesterol may increase, which could also help to keep your levels of LDL and total cholesterol in check.

Your total cholesterol level is in the Desirable range, but your level of "bad" LDL cholesterol is High. This may mean that your level of high-density lipoprotein (HDL), or "good" cholesterol, is too low. It is best to have a high level of "good" HDL and a low level of "bad" LDL. The HDL helps keep your LDL level in check. Ask your doctor for your HDL level. If your HDL is low, increasing your physical activity can increase it, which may help reduce your LDL level.

Your total cholesterol level is in the Desirable range, but your level of "bad" LDL cholesterol is Very High. This may mean that your level of high-density lipoprotein (HDL), or "good" cholesterol, is too low. It is best to have a high level of "good" HDL and a low level of "bad" LDL because the HDL helps keep your LDL level in check. Ask your doctor for your HDL level. If your HDL is low, increasing your physical activity can increase it, which may help reduce your LDL level.

Your total cholesterol level is Borderline High, but fortunately your level of "bad" LDL cholesterol is optimal. This could mean you have a high level of high-density lipoprotein, or "good" HDL cholesterol, which protects against heart disease. Or you could have other non-measured increases in LDL-like particles that can increase heart disease. Your LDL level also could be optimal if you are taking a statin medication. Please check with your doctor to get your complete lipid profile and see if you may need additional treatment. In the meantime, find more information on WebMD's Cholesterol Health Center.

Your total cholesterol level is Borderline High, but fortunately your level of "bad" LDL cholesterol is near optimal. This could mean you have a high level of high-density lipoprotein, or "good" HDL cholesterol, which protects against heart disease. Or you could have other non-measured increases in LDL-like particles that can increase heart disease. Your LDL level also could be optimal if you are taking a statin medication. Please check with your doctor to get your complete lipid profile and see if you may need additional treatment. In the meantime, find more information on WebMD's Cholesterol Health Center.

Your total cholesterol level is Borderline High. Your level of "bad" LDL cholesterol is Borderline High, too. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels!

Your total cholesterol level is Borderline High. Your level of "bad" LDL cholesterol is High. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels!

Your total cholesterol level is Borderline High. But your level of "bad" LDL cholesterol is Very High. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels!

Your total cholesterol is High, but your level of "bad" LDL cholesterol is optimal. This could mean you have a high level of high-density lipoprotein, or "good" HDL cholesterol, which protects against heart disease. Or you could have elevated secondary lipids, such as non-HDL particles that increase the risk of heart disease. Your LDL level also could be optimal if you are taking a statin medication. Please check with your doctor to get your complete lipid profile and see if you may need additional treatment. In the meantime, find more information on WebMD's Cholesterol Health Center.

Your total cholesterol is High, but your level of "bad" LDL cholesterol is near optimal. This could mean you have a high level of high-density lipoprotein, or "good" HDL cholesterol, which protects against heart disease. Or you could have elevated secondary lipids, such as non-HDL particles that increase the risk of heart disease. Your LDL level also could be optimal if you are taking a statin medication. Please check with your doctor to get your complete lipid profile and see if you may need additional treatment. In the meantime, find more information on WebMD's Cholesterol Health Center.

Your total cholesterol level is High. Your level of "bad" LDL cholesterol is Borderline High. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels!

Your total cholesterol level is High. Your level of "bad" LDL cholesterol is High, too. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels! If you are struggling to bring down your total cholesterol and LDL cholesterol levels, your doctor may prescribe medication, such as statins. Following medication, dietary, and exercise instructions should result in improvements.

Your total cholesterol level is High, and your level of "bad" LDL cholesterol is Very High. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels! If you are struggling to bring down your total cholesterol and LDL cholesterol levels, your doctor may prescribe statins or other cholesterol-lowering medications.

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