Atorvastatin calcium tablets are a generic form of Lipitor, but Pfizer… (Bill Gallery / Associated…)
Lipitor is the most prescribed name-brand drug in America — nearly 3.5 million people take it every day to control their cholesterol. Since the statin entered the market in 1997, it's earned New York-based pharmaceutical giant Pfizer Inc. $81 billion, making it the best-selling prescription drug of all time, according to IMS Health, a Danbury, Conn.-based healthcare information company.
So when Lipitor's patent protection came to an end Nov. 30 and a generic alternative became available, an awful lot of patients had a decision to make: Should they stick with the drug they knew or switch to something less expensive?
But a funny thing happened on the way to the pharmacy.
In a concerted effort to hang on to its customers, Pfizer cut deals with insurers and with companies that process prescriptions as part of an elaborate effort to keep Lipitor available at prices that are just as cheap as — or even cheaper than — the generic competition. The company has also appealed directly to patients to stick with the brand instead of switching to generic atorvastatin with a program that makes Lipitor available for as little as $4 for a 30-day supply.
It was an unprecedented effort, but the motivation was clear: When a drug loses its patent protection, more than 80% of its prescription sales are replaced by generics within six months, according to IMS.
Usually when a drug goes off patent, patients are forced by their insurance companies to switch to generics they may not want; in this case, consumers who want generic Lipitor may not be able to get it.
Here's a guide to what's going on with the blockbuster drug.
Is atorvastatin as good as Lipitor?
The expectation is that the generic will be just as effective as the name-brand drug.
But contrary to popular belief, generics aren't identical to brand-name drugs, says pharmacologist Joe Graedon, co-creator of the consumer health column the People's Pharmacy. In fact, he says his website has become a magnet for reporting problems with generic drugs, which occur for three main reasons: the contents of a generic's inactive ingredients are usually different from those found in the brand-name drug; uninspected foreign manufacturing plants sometimes produce contaminated chemicals; and generics can be released into the bloodstream differently from how it acts in the brand-name version.
Graedon says Lipitor's release mechanism is not unique, and he doesn't anticipate trouble with atorvastatin.
Besides, Lipitor may not be much different from a variety of other statins that already are sold as generics, says Dr. John Santa, director of health ratings for the nonprofit Consumer Reports. Generic statins — the class of cholesterol-lowering drugs to which Lipitor belongs — are just as good for 95 out of 100 people, Santa says. These include lovastatin (Mevacor), pravastatin (Pravachol) and simvastatin (Zocor).
In fact, Pfizer's incredible success with Lipitor may primarily be a function of the company's marketing brilliance, Santa says. "Pfizer was able to convince millions of Americans to ignore less expensive and just as effective drugs," he says.
My doctor wrote me a prescription for atorvastatin, but I was given Lipitor instead. Why can't I get the generic?
It's because of the deals Pfizer has made with insurance companies and pharmacy benefit managers, which negotiate drug prices for insurers.
Normally, one drug maker gets exclusive rights to make the low-cost generic version of a medication for the first six months after it goes off patent. After that, additional generic drug makers enter the market, causing prices to drop even further. At that point, demand for the brand-name drug all but disappears.
But Pfizer is trying to rewrite that story. It agreed to pay rebates to insurers and pharmacy benefit managers (PBMs) to eliminate the cost advantage of atorvastatin. In return, some of the companies are offering only Lipitor.
Pfizer spokesman MacKay Jimeson says the deals allow patients to get the brand-name medicine at generic prices. It seems to be working. According to the Dutch business intelligence firm Wolters Kluwer Pharma Solutions, Pfizer has managed to hold on to about 57% of all retail Lipitor sales since Dec. 1.
That sounds sneaky. Is it legal?
No laws that govern how generics enter the market have been broken, says Erik Gordon, an attorney and professor at the University of Michigan's Ross School of Business. But Pfizer's actions do raise questions about whether antitrust laws, which aim to keep market competition fair, have been violated, Gordon says.
What's tricky is that Pfizer, the biggest drug maker in the world, seems to be using its muscle to make deals with the aim of undercutting the sale of generic Lipitor and limiting consumers' access to it, Gordon says.