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Sales of Vytorin and Zetia both were hurt when Merck, under pressure from a congressional probe, in early 2008 finally released unfavorable results from a study it had hoped would bolster Vytorin sales. Instead, it showed that Vytorin was no better at reducing plaque buildup in neck arteries than just Zocor, which had been available as a cheap generic since 2006. Zetia, also known as ezetimibe, is protected by patent in the U.S. until 2017.
Lipitor, which had peak sales of around $13 billion, is a more powerful statin then Zocor. That could mean that if the new combination drug is approved, it would be tried by at least some patients who have not been able to get their cholesterol numbers to their goal with Vytorin or other treatments.
Meanwhile, last year Lipitor maker Pfizer sued, alleging Merck's application for the FDA to approve the Zetia-atorvastatin combination infringed on a Pfizer patent covering atorvastatin.
A Merck spokeswoman said Monday that the lawsuit "has the potential for holding up FDA approval of the Merck product until" the first quarter of 2014.
Copyright 2012 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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