
AstraZeneca files suit to block FDA from approving copies of cholesterol drug Crestor
pharmafile | July 11, 2016 | News story | Sales and Marketing |ย ย AstraZeneca, Crestor, US FDA, patent, regulationย
Anglo-Swedish drug firm AstraZeneca (LSE: AZN) has filed a temporary restraining order to prevent the US Food and Drug Administration from approving generic versions of its biggest selling cholesterol drug Crestor (rosuvastatin) set for patent expiry.
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.
The FDA has already tentatively cleared several applications for generic Crestor, according to the request filed in US district court for the District of Columbia. The company has argued that the imminent final approvals lead to immediate and irreversible loss of about $400 million in net sales, among others.
Crestor was granted orphan drug status in 2014 for paediatric homozygous familial hypercholesterolaemia along with an additional seven years of exclusivity for the new indication when the label was expanded this past May.
In February, AstraZeneca predicted that its sales and earnings per share would likely decline this year.
Allergan received FDA approval in April to market the first generic version of Crestor in the US, with the company introducing its product soon after in what it said would likely be the largest generic launch in 2016.
Anjali Shukla
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