Healthy Skepticism Library item: 16871

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Publication type: Electronic Source

Goldstein J
How a Decades-Old Drug Is Still a Patented Blockbuster
The Wall Street Journal Blog 2009 Dec 1
http://blogs.wsj.com/health/2009/12/01/how-a-decades-old-drug-is-still-a-patented-blockbuster/

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.”