AstraZeneca Sues FDA to Prevent Generic Competition for Crestor

June 29, 2016

The drug maker AstraZeneca has sued the FDA to prevent generic competition for its anti-cholesterol drug Crestor (rosuvastin calcium), demanding market exclusivity for 7 years for all of the drug's approved indications.

Crestor is most commonly prescribed for adults with high cholesterol. According to IMS Health, Crestor was the second-most prescribed brand-name drug in the United States in 2015, with the drug being prescribed 20.3 million times.

Crestor won FDA approval in late May for the treatment of children with the rare disease homozygous familial hypercholesterolemia (HoFH). It is estimated that between 300 to 1000 people in the United States have the disease, involving two deleterious mutations, one from each parent. Katherine Wilemon, president of the FH Foundation, an advocacy group, said that some with the disease experience heart attacks when they are only 5 years old.

Because HoFH is a rare disease, Crestor’s approval came with market exclusivity rights for 7 years, but in that indication only. The drug is scheduled to lose patent protection on July 8, at which time generic versions of the drug may become available for the treatment of high cholesterol in adults.

Now, AstraZeneca has filed a lawsuit against the FDA to extend its exclusivity rights, claiming that if the correct dose for children with HoFH could not be placed on the generic label, then it would be dangerous to approve generic versions for any use. Furthermore, the lawsuit claims that such a labeling approach is not legal and would violate the FDA’s own rules on including pediatric information in drug product labels.

Although it is uncertain whether the FDA will begin approving generics on July 8, similar attempts to block generic competition in the past have failed. AstraZeneca says it plans to work with the FDA on an expedited schedule for the case but that, if the agency refuses, the company will file for a temporary restraining order while the legal argument is pending.



Pollack A. AstraZeneca Pushes to Protect Crestor From Generic Competition. New York Times. June 27, 2016.

Staton T. With no time to waste, AstraZeneca sues FDA to block Crestor copycats. Fierce Pharma. June 29, 2016.