Pharmaceutical giant AstraZeneca failed to block approval of generics for its best-selling cholesterol drug after a federal judge tossed out the company's request.
A federal judge in Washington, D.C., denied the drugmaker's request Tuesday for a temporary restraining order against the Food and Drug Administration in an attempt to prevent generic manufacturing of its drug Crestor. The ruling allows generic companies to officially manufacture generics of the drug.
In an emailed statement, AstraZeneca said, “While we are disappointed with this decision, we appreciate the court's careful consideration in addressing these important issues. We are currently assessing our options.”
In the lawsuit, AstraZeneca argued that its drug Crestor should be entitled to seven years of additional market exclusivity under the Orphan Drug Act. The British-based company won market exclusivity for the drug in May 2015 but only to treat a rare genetic disease in children called homozygous familial hypercholesterolemia. The decision Tuesday allows the FDA to approve generic versions of the drug to use against conditions.
Crestor is AstraZeneca's best-selling drug, accounting for $5 billion of its $23 billion in sales last year.
