AZ Files Lawsuit Against FDA to Stop Generic Competition of Crestor

AstraZeneca is suing the FDA in an exclusivity dispute over its anti-cholesterol drug Crestor, claiming that the agency’s interpretation of the FD&C Act unfairly subjects the drug to early generic competition.

The British drug giant alleges that because Crestor currently has orphan drug exclusivity for pediatric homozygous familial hypercholesterolemia, the FD&C Act prohibits the FDA from granting final approval to generic versions of the drug until that exclusivity expires in May 2023.

Specifically, the company contends that any generic version of the drug must include all pediatric labeling information for the drug, including the exclusivity-protected HoFH indication Crestor was granted in May. This demand effectively prevents generic competition for the drug because protected indications cannot appear on competitors’ products.