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Crestor ANDAs May Seek Approval For Unpatented Uses, Appeals Court Rules

 
• By Brenda Sandburg

The Federal Circuit ruled that AstraZeneca cannot claim infringement of unpatented uses of rosuvastatin; the court affirmed the validity of section viii labeling carve-outs.

AstraZeneca Pharmaceuticals LP lost its fight to block ANDAs of Crestor (rosuvastatin) that carve out patented indications of the cholesterol-lowering drug. Generic manufacturers will thus be able to launch their products when Crestor’s composition patent expires in 2016.

In a Feb. 9 decision, the U.S. Court of Appeals for the Federal Circuit affirmed a district court ruling that AstraZeneca cannot claim infringement of unpatented indications. It also reiterated...

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