AstraZeneca recently received FDA approval to use Crestor, its blockbuster cholestrol drug, to treat children with extremely high levels of “bad” cholesterol. This is a rare condition, and is what could help the company extend patent protection on the drug. It’s also a group that could mean billons in dollars in sales.
AstraZeneca wants to use this new treatment to extend its patent clock, which expires next month. The extension would be for another seven years and would be done by classifying Crestor as an “orphan drug.” There would need to be a special designation created by Congress to give drug makers the incentive to cure rare diseases.
“AstraZeneca believes federal law entitles the company to an additional exclusivity period of seven years for Crestor in the US,” Michele Mexiell, a spokeswoman, wrote in an email.
“Because it doesn’t expect an FDA decision before its patent expires, the company has filed suit to block generic competition, she said.
Critics argue that AstraZeneca is trying to abuse the law, since the overwhelming use of Crestor is for treating adults with high cholesterol, not children with the rare disease.
“This represents a deviation from the intent of the Orphan Drug Act,” said Dr. Martin A. Makary, a professor of health policy at Johns Hopkins Medical School. “It is now being used to dominate the market with retrofitted indications.”
Crestor was prescribed 20.3 million times in the United States in 2015. It is the company’s best-selling drug, accounting for $5 billion of its $23.6 billion in product sales last year.
Disclaimer: We have no position in AstraZeneca plc (NYSE: AZN) and have not been compensated for this article.