Judge Dismisses AstraZeneca’s Bid to Block Generic Crestor

AstraZeneca has lost its bid to stop the US Food and Drug Administration from approving any new generic versions of its blockbuster statin, Crestor. 

On Tuesday in Washington, DC, US District Judge Randolph Moss refused to grant a temporary restraining order that would block new generic versions of rosuvastatin from entering the market, ruling that AstraZeneca was unlikely to win a lawsuit it launched against the agency on June 27. As previously reported by TCTMD, AstraZeneca lawyers sued the agency after it failed to act on a citizen’s petition, filed on May 31, requesting that it not approve any abbreviated new drug applications or new drug applications for Crestor until the expiration of its orphan drug exclusivity.

The company had earlier been awarded a 7-year exclusivity extension for Crestor under the Orphan Drug Act for the treatment of pediatric patients ages 7 to 17 with homozygous familial hypercholesterolemia. The company has argued that this extension should protect its brand-name drug against copycat medications intended for the vastly larger adult primary prevention population.

Bloomberg reports that three generics companies have already received approval to start selling their rosuvastatin copies this month—Aurobindo, Glenmark Pharmaceuticals, and Sun Pharmaceutical Industries. A fourth company, Allergan Plc’s Watson Pharmaceuticals, started selling its generic version in early May after being granted exclusive rights to do so following a patent litigation settlement. Reuters reports that Apotex, Myland, and Novartis AG unit Sandoz, have also stated, in court filings, their intention of launching generic versions of Crestor.

AstraZeneca is widely reported to have made at least $5 billion in annual sales from its brand-name drug—revenue that will plummet as generics flood the market.





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