FAQ: Generic Lipitor

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:

• Crestor (rosuvastatin)
• Lescol (fluvastatin)
• Lipitor (atorvastatin)
• Livalo (pitavastatin)
• Mevacor (lovastatin, already available in generic form)
• Pravachol (pravastatin, already available in generic form)
• Zocor (simvastatin, already available in generic form)

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."