With several ANDAs for generic versions of cholesterol treatment Crestor awaiting approval by the FDA, AstraZeneca is suing the agency to prevent approvals prior to May 2023.
The suit asks the court to prevent the FDA from approving any generic Crestor products before AstraZeneca’s seven-year orphan drug exclusivity period on a rare-disease use expires in 2023. FDA granted orphan drug exclusivity on Crestor for a rare pediatric genetic disorder called Homozygous Familial Hypercholesterolemia (HoFH).
However, Crestor is set to lose market exclusivity July 8 when a six-month period of pediatric exclusivity on Crestor's main compound patent expires. Critics contend that AstraZeneca's lawsuit is abusing the law, since the overwhelming use of Crestor is for treating adults with high cholesterol, not children with the rare disease.
Crestor has been a blockbuster product for AstraZeneca, with global sales totaling $5 billion in 2015.
Read the Bloomberg article