Crestor ANDAs May Seek Approval For Unpatented Uses, Appeals Court Rules
Executive Summary
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.
You may also be interested in...
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.
Companies Reveal Hurdles In Providing Drugs Via Expanded Access Programs
GSK, Stealth BioTherapeutics and Blueprint Medicines discuss the difficulties getting participation of physicians, the excessive cost of expanded access, and whether physicians should report research data.