Crestor ANDAs May Seek Approval For Unpatented Uses, Appeals Court Rules
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.
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Expiration of the Lipitor patent puts tremendous pressure on AstraZeneca’s bestselling statin, Crestor, which accounts for 20% of total revenues. AstraZeneca insists the drug’s value proposition will enable it to withstand the onslaught, but analysts expect a gradual chipping away at market share.
The high court hears oral arguments in a case that could limit the ability of generics to carve out still-patented uses from their labeling to get prompt ANDA approval. Brand manufacturers argue that allowing such challenges will invite a flood of lawsuits. Caraco v. Novo revolves around a patent use code for the diabetes drug Prandin.
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