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Drugmaker AstraZeneca pushes to protect Crestor from generic competition

Published Wed, Jun 29, 2016 · 09:50 PM

New York

NO more than a few hundred US children have a rare disease characterised by ultra-high levels of bad cholesterol. Yet, to the giant drugmaker AstraZeneca, this small group could be worth billions of dollars.

The company is making a bold attempt to fend off impending generic competition to its best-selling drug, the anti-cholesterol pill Crestor, by getting it approved to treat the rare disease. In an unusual legal argument, the company says Crestor is entitled to seven years of additional market exclusivity under the Orphan Drug Act, a three-decade-old law that encourages pharmaceutical companies to develop treatments for rare diseases.

Critics say AstraZeneca is trying to abuse the law, since the overwhelming use of Crestor is for treating adults with high…

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