As Lipitor’s Patent Expires, Is Era of ‘Blockbuster Drugs’ Over?

After 14 years on the market, the most profitable prescription drug in history, Lipitor, is going generic as patients, doctors and the pharmaceutical industry wait to see what will happen. Margaret Warner discusses the implications with Dr. Jerry Avorn of Harvard Medical School.

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    And finally tonight, a blockbuster drug goes generic, and patients, doctors and the pharmaceutical industry all have an interest.

    Margaret Warner has the story.


    It's been the most profitable prescription drug in history, with many millions of people taking it over the last 14 years.

    But, today, Lipitor, a so-called statin that lowers cholesterol levels, lost its patent protection, opening the door to low-cost generics. Lipitor accounted for more than $10 billion in worldwide sales last year for its manufacturer, Pfizer, and more than $130 billion over the patent's life. It's the first of several blockbuster drugs due to lose their patents in the next year.

    We look at the implications of all this now with Dr. Jerry Avorn, a professor at Harvard Medical School and a senior physician at Brigham and Women's Hospital in Boston. He's also the author of the book "Powerful Medicines."

    And, Dr. Avorn, thank you so much for being with us.

    How big a change is this for the world of pharmaceuticals and for consumers to have Lipitor going off patent today?

  • DR. JERRY AVORN, Harvard Medical School:

    Well, for consumers, it's welcome news for those who are on Lipitor, because they will be able to switch to the generic drug, which is called atorvastatin, and it's the exact same molecule. It will work every bit as well, and it's going to cost a fraction of what they have been paying thus far. So, from that perspective…


    How small a fraction?


    Well, Lipitor is now selling for about $5 a pill. It probably costs about a dime a pill to make. So it's a nice business to be in with that kind of a markup.

    And probably the rate will drop down to maybe about half as much initially, and then even lower than that. There are statins that are now available at discount stores for $4 a month, as opposed to $5 a pill. So it could well get down into that $4- to $10-a-month category, certainly after six months, when there will be many more generic manufacturers selling it.


    Now, Pfizer, though, is fighting back against generic competitors.


    Yes, they are.

    It's really kind of like trying to hold back the tide, because, in six months, because of a variety of legal reasons, there will be many generic manufacturers. And, at that point, Pfizer can't keep fighting them all back.

    I think what it's trying to do is just preserve whatever franchise it can in the waning months of its availability on the market. And, frankly, I would rather that all of that enormous creativity that they're showing in ways of dealing with this legally and through deals and economically were being spent on developing new products, rather than trying to figure out other ways to get people not to use the generic.


    But explain what they're trying to do. It's quite a novel approach.


    It involves arranging deals with prescription benefit management companies to not make the generic available. It involves making coupons available to patients to bring down the co-pay to get them to stay on Lipitor, as opposed to the generic.

    It involves a variety of kind of side deals with insurers, with druggists, with anybody who's a player to try to desperately hang on to a couple more months of Lipitor use.


    Now, is there not a debate about whether generics are — quote — "as good" or at least as reliably good as the brand name manufacturer, or do you consider that a settled point?


    It's not subtle. And it should not be a debate. And it should not have been a debate for decades.

    Generics are every bit as good as the brand name drugs. There's a lot of disinformation that gets spewed out there. It's not scientifically accurate information. All the data we have is that generics are every bit as good as the brand name products. They're held to the same high standards by FDA. They contain the exact same molecules in the exact same strength.

    And I really wish that that old canard about generics don't work as well could be put to bed, because it hasn't been true, and it isn't true.


    So, now, as I said in the introduction, there are other blockbuster drugs like Lipitor, for instance, Plavix, the blood thinner, that have been a hefty chunk of the sales of the company, of the manufacturer.

    Are there other such drugs in the — either on the market or in the pipeline, or are we seeing a turning point in the industry?


    Well, there are people who have said the era of the blockbuster drug is over.

    And when I think of blockbusters like Vioxx or Avandia, both of which cause heart attacks, maybe those blockbusters, we won't miss so much. But there could be new blockbusters coming along. There's a variety of new drugs for treating — anticoagulants, or blood thinners, for treating a condition called atrial fibrillation that are just coming to market.

    Some of them could be blockbuster, if, by that, I mean billion-dollar-a-year drugs. But we may see fewer of them than we have in the past, in part because people are looking much more carefully at how we spend every health care dollar. And a lot of the blockbusters of recent years probably, if they had been subjected to the kind of scrutiny that drugs are going to get from here on out — and, again, I'm thinking of Avandia and Vioxx — may never have been blockbusters in the period that we're living in, in the first place.


    And is it also the case that the blockbuster drugs, as we call them, apply to just such a huge class of people, and that now the whole nature of the research and the formulas for various drugs has become more refined, more targeted?


    Well, I wouldn't dismiss the possibility that there is going to be some wonderful new drug that we can't even imagine. I think nobody saw Google or Facebook coming a few years before they hit the streets, and they were in a sense blockbusters of their own.

    There's a lot of exciting science going on. And I wouldn't rule out the possibility of some really exciting major drugs for huge numbers of people coming down the road. It's just a little hard to know what they might be sitting here in 2011.


    Well, Dr. Jerry Avorn, Harvard Medical School, thank you so much.


    You're very welcome.