For the roughly three million Americans who have been taking the brand-name drug Lipitor to reduce their cholesterol, the day they’ve been waiting for has come. On November 30, 2011, this statin drug—which rings up annual sales in the neighborhood of $8 billion for Pfizer, its manufacturer—lost its patent protection, meaning that many different manufacturers can now compete to make the drug in a generic version called atorvastatin. This is good news for consumers because generics tend to be much cheaper than brand-name drugs, and Lipitor itself costs $115 to $160 a month, depending on the dose. But if you are on Lipitor, you may wonder, Is the generic really the same as the brand-name drug?
WHAT THE LAW SAYS
To talk through how similar (and how different) Lipitor and generic atorvastatin are likely to be, I called William Pong, PharmD, administrative director of pharmacy services at Loyola University Medical Center in Maywood, Illinois, who regularly handles patient concerns and questions about generics versus brand-name drugs. The answer is a bit complicated, as you will see, but it is mostly reassuring. To receive FDA approval, generic drugs must meet a variety of criteria, including some of the following.
A generic drug must have:
- The same active ingredient or ingredients as the brand-name drug.
- The same strength as the brand-name drug.
- The same route of delivery (oral, topical, injectable, etc.).
- The same dosage form (capsule, tablet, etc.).
So, looking at that list above, you might think that it tells you all you need to know…generics are essentially identical to brand-name drugs…yay, generics! But that’s not the case, as Pong rightly pointed out—and it’s not all that you need to know.
WHAT HAPPENS IN REAL LIFE
The fact is, there is some wiggle room. When the FDA says that active ingredients need to be the same in generic and brand-name drugs, what it means is that the ingredients have to be what’s called “bioequivalent.” The allowable amount of the active ingredient in the generic drug can be within 5% of what’s in the brand-name drug. And the amount of the active ingredient in a generic drug that gets absorbed in your bloodstream usually falls within 10% of what’s absorbed from the brand-name drug (on average, research shows that the difference is within 3.5%). In other words, compared with a brand-name drug, you could potentially absorb 90% of the active ingredient in the generic drug…or 110% of it…or any amount in between.
So generics are not the same after all. The good news, though, is that Pong said that having a little bit more or a little bit less of the active ingredient in your bloodstream usually doesn’t matter, and here’s an example of why. Suppose that you decide to stop taking Lipitor and take generic atorvastatin instead, and you absorb only, say, 90% of the active ingredient that you were getting from Lipitor. The worst that could happen, Pong said, is that your cholesterol rises a point or two. Now say that you’re taking a different generic version of atorvastatin and you absorb 110% of the active ingredient that you’re used to getting—then your cholesterol might drop a point or two. Neither situation would be cause for concern, said Pong, because the differences are “clinically insignificant in terms of both efficacy and safety.”
The situation is worrisome, said Pong, if you’re taking one of the relatively few drugs that are considered critical-dose medications. With those, you may need to stick with the brand-name drugs. Lipitor is not a critical-dose drug…but to find out if any of your drugs are, talk to your doctor. Pong said that some examples include seizure medications and lithium for bipolar disorder.
WHAT ELSE IS IN THERE?
Although the active ingredients are basically the same in brand-name and generic drugs, there are also a host of inactive ingredients, which are not necessarily the same. This means that you could have new side effects, depending on which generic you take, due to a new inactive ingredient. So if you switch to a generic and have a very mild reaction, Pong said to give yourself a day or two, because your body might adjust. But if mild symptoms persist or if you have a more severe reaction, call your doctor right away.
Also: Don’t be surprised when you first see your generic drug—it may have a different size, shape and/or color than what you’re used to, because the look of Lipitor is trademarked. And don’t get too used to your new generic version either—because if a generic manufacturer quits making it or raises the price, your pharmacy might start getting a generic from a different manufacturer. So your pills could even look different from month to month. (See Daily Health News, March 26, 2011, “Why It Matters What Your Pills Look Like.”)
THE TRUTH ABOUT COST SAVINGS
All in all, if you switch to a generic version of Lipitor, you’ll probably be paying less—but prices aren’t going to drop significantly immediately. In an unusual deal, during the first six months that Lipitor is off-patent, the FDA has given permission to make and sell generic versions of the drug to a limited number of manufacturers—a partnership between the companies Ranbaxy and Teva…and also the generic division of Pfizer—yes, that Pfizer. So look for the price to start tumbling around May, when the race to produce generic atorvastatin becomes wide open.