US federal court issues restraining order against FDA's approval for generics of Hospira's Precedex

A judge in US federal court has issued a temporary restraining order following the US Food and Drug Administration’s decision to allow the sale of generic versions of sedative Precedex (dexmedetomidine), produced by Hospira (NYSE: HSP). The judge ruled on the grounds that Hospira was likely to win its law suit against the FDA.

Precedex is Hospira’s top product, bringing in $4.1 billion and constituting 11% of its global net sales. Novartis has an agreement with Hospira to launch a generic of Precedex in December subject to certain conditions, and has suggested that the FDA’s ruling would deprive the drugmaker of its exclusivity period.

The law suit came as Mylan said this week it had begun shipping generic Precedex to the market on Monday, the same day the FDA approved generic versions of Precedex with prescribing labels that omit information about intensive care unit use and only include information about the drug’s use in other settings. This is due to the fact that Hospira’s only remaining patent covers Precedex for use in sedation in an intensive care unit. All other patents have expired already.