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Judge Clears Path for Generic Versions of Crestor

By Andy Szal | July 22, 2016

Generic versions of a popular cholesterol drug are poised to make their debut after a federal judge refused to block their approval earlier this week.

AstraZeneca’s trademark on Crestor expired recently, but the London-based pharmaceutical giant filed a lawsuit seeking seven more years of trademark protection due to the recent approval for treatment of pediatric homozygous familial hypercholesterolemia.

The company last month received seven years of exclusive marketing rights for use of the drug to treat the rare genetic disorder — which causes high cholesterol — but Reuters reports that U.S. District Judge Randolph Moss found that the company was unlikely to prevail in its lawsuit.

Moss declined to issue a restraining order on generic versions of the drug, known as rosuvastatin, which clears the way for new versions from several companies. Sandoz, Apotex and Mylan indicated that they were prepared to introduce generic versions.

A currently available generic version, produced by Allergan under an agreement with AstraZeneca, was not affected by the ruling.

AstraZeneca officials said that the company was “disappointed” with the decision; Crestor accounted for more than 20 percent of the company’s 2015 sales, Reuters reported.

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Filed Under: Drug Discovery

 

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