AstraZeneca Sues FDA, Seeks to Bar Crestor Copies Until 2023

AstraZeneca Pharmaceuticals is suing the FDA to prevent the agency from approving generics of its cholesterol treatment Crestor in July (AstraZeneca Pharmaceuticals LP v. Burwellcomplaint filed).

The suit asks the court to permanently enjoin the FDA from approving any generic Crestor products before May 27, 2023, when AstraZeneca’s seven-year orphan drug exclusivity period on a rare-disease use expires. The company filed suit in the U.S. District Court for the District of Columbia on June 27.

Crestor (rosuvastatin calcium) is set to lose market exclusivity July 8 when a six-month period of pediatric exclusivity on Crestor’s main compound patent ...