1 + 1 = Huge Windfall for Drug Company About to Lose Patent Protection on a Very Important Drug
Newsday does a good job of framing a problem that has become more common as the titans of pharma deal with big ticket drugs that are falling off of patent protection. At issue is Lipitor, the statin that lowers levels of LDL cholesterol. Pfizer will lose patent protection for Lipitor in 2010, which matters just a little bit because the company earned $10.9 billion last year alone in revenue from the drug.But what if there were a new drug pill that contains two medications - and could produce from the ashes of Lipitor a new "Lipitor-based" product?
That is the hope for Pfizer, who are combining a new drug that elevates levels of HDL (good) cholesterol with Lipitor. It would be a "combination" pill, not unprecedented but certainly never attempted at this scale.
Newsday quotes all sorts of ethics and health service research types about whether it might be a tad disingenuous to make this kind of maneuver with Lipitor.
Pfizer's strategy raises the question of "who's writing the prescription - the drug company or the doctor?" says George Annas, chairman of the health law department at Boston University. "On the surface of it, it looks like they're promoting Lipitor. It looks more like a marketing move than a public health move."But what's the real harm in combining the two drugs in the form of a new product? In 2010, physicians will be able to choose to prescribe a generic form of Lipitor. But the leverage achieved by combining the two drugs will enable the company to charge a fortune for a 'new kind' of Lipitor, and for access to the other medication - which will be bundled with Lipitor.
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Neil Swidey ran a great piece in the Boston Globe Magazine a few years ago about how Astra-Zeneca kept its patent on Prilosec beyond the set time-limit.
Basically, if I recall, they claimed the patent for the prilosec had expired, but not the patent for the encapsulation method, and that generic distributors, trying to use their own methods, would be infringing.
This bought them a few years of legal wrangling, at which point Nexium was ready. Nexium is an enantiomer of prilosec -- same atoms, virtually the same arrangement. It works the same. But they've got another decade or so to milk this cash cow.
- by Nick on Apr 26, 2005 at 1:38 AM | link
And what of the pt who needs torcetrapib, but cannot tolerate lipitor? They're SOL, as far as I can tell. If I were FDA chief, I'd find a way to force them to release the new drug separately AND in combination.
- by moioci on May 3, 2005 at 5:16 AM | link