New Court Battle May Dictate How Generics Can Use Label Carve Outs To Enter Market

An emerging court battle over the generic drug Precedex, if successful, could arm branded drug companies with a way to block generic drug competition by preventing label carve outs with Orange Book patent listings, industry attorneys said. Hospira sued FDA last week after the agency approved generic versions of the company's sedation drug Precedex with labeling that carved out a patent-protected use; Hospira contends that the product's two uses overlap and the product is still under patent protection. A short-lived...