AstraZeneca loses legal bid to block Crestor generics

pharmafile | July 20, 2016 | News story | Research and Development, Sales and Marketing |  AstraZeneca, Crestor, FDA, generics, legal 

A US district court judge has refused AstraZeneca’s request for a temporary restraining order blocking the approval of generic versions of its blockbuster cholesterol drug, Crestor (rosuvastatin), in the US.

The drug, which lost patent protection earlier this month, generates revenues of around $5 billion a year, constituting around 20% of AstraZeneca’s overall revenue. The company had sought to extend its exclusivity to the drug by suing the FDA in a bid to prevent the approval of generic versions.

The company said the regulator should hold off any approvals until a decision is made on its claim that the statin is protected by seven more years of exclusivity due to a paediatric indication. AstraZeneca had initially won seven years of exclusive marketing rights to the drug in a new paediatric indication, with an orphan drug designation.

US District Court judge Randolph Moss indicated in his ruling that AstraZeneca was unlikely to win a lawsuit claiming it should receive seven more years of exclusive rights based on this paediatric designation.

Companies such as Novartis, Apotex and Mylan have indicated their intention to file generic versions of the drug in the near future. Allergan launched its own generic version of the drug in the US in May, while Sun Pharma has just received final approval for its own generic.

According to Reuters, an AstraZeneca spokesperson said the company was “disappointed” with the decision.

Sean Murray