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Healthy Skepticism Library item: 16871

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.


Publication type: Electronic Source

Goldstein J
How a Decades-Old Drug Is Still a Patented Blockbuster
The Wall Street Journal Blog 2009 Dec 1

Full text:

Abbott isn’t likely to face generic competition on its cholesterol drug TriCor until at least March, 2011, according to an SEC filing the company put out yesterday. Filings like this come out all the time, but this one is particularly striking because the key compound in TriCor, generically known as fenofibrate, was discovered in the 1960s and hit the market in Europe in 1975. Drugs that old are almost always generic.

Abbott licensed the compound to sell in the U.S. in 1998, and has been jockeying to keep it patented protected ever since, as this WSJ story explained last year.

In 1999, a generic drug company that was later acquired by Teva applied to market a generic version of TriCor. Abbott sued for patent infringement, changed the dosage of TriCor and changed it to a tablet from a capsule. Then the company filed for a patent on the slightly modified form of the drug and bought back the capsules that pharmacies still had on their shelves.

Because the company had changed the type of pill and the dosage, pharmacists couldn’t swap in the generic capsules Teva planned to introduce, because they were no longer identical to the tablets Abbott was selling. In 2002, Teva asked the FDA for permission to sell a generic version of the tablets, and Abbott again altered the dosage and formulation.

Last year, Abbott agreed to pay $184 million to settle litigation that alleged the company created a monopoly and prevented generic competition for TriCor. Other lawsuits in the matter are still pending. The company denied wrongdoing.

Also last year, the FDA approved a new Abbott drug called Trilipix, which is similar to TriCor but which is approved for use in combination with statins, a popular class of cholesterol drug. Now Abbott is busy trying to get patients to switch from TriCor to TriLipix before TriCor goes generic.

Yesterday’s SEC filing didn’t disclose any details of the deal between Teva and Abbott. Abbott didn’t pay Teva to delay selling a generic, according to an Abbott spokeswoman. (“Pay-for-delay” deals have come under a lot of regulatory scrutiny lately.) The spokeswoman told the WSJ the deal is a “pure licensing agreement.”


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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909