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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Amid The Lipitor Scuffle, What’s Next For Crestor?
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.
Patent Use Codes: Will Supreme Court Curb Carve-outs Or Spawn Suits?
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.
Device Component Of Intarcia’s Diabetes Treatment ITCA 650 Worries FDA
If FDA chief scientist grants Intarcia’s request for advisory committee meeting, CDER wants to provide input on issues to be considered. Director Cavazzoni says the novel drug-device combination product does not notify the user of a critical failure or infusion status.