Hospira challenges FDA’s “unlawful” approval of Precedex generics

Illinois-based drug company Hospira has sued the US Food and Drug Administration (FDA), challenging its recent decision to approve generic versions of Precedex (dexmedetomidine hydrochloride).

Precedex is an intravenous sedative used in an intensive care setting. It has one patent listed in the Orange Book, which has been licensed to Hospira by Finnish pharmaceutical company Orion, and is due to expire in 2019.

Filing at the US District Court for the District of Maryland yesterday (August 19), Hospira asked the court to enjoin implementation of the decision, which is said was based on a “clear error of law”, and to recall any generic products sold under the decision.

It argued that the decision was an “unlawful application” of the FDA’s authority, as the generic product labels an indication that overlaps with a use covered by the branded product’s patent. The generic must propose a label that “carves out” the patented method of use from the brand drug’s labelling, it said.

“The FDA’s role is ministerial only and it may only approve such a carve-out where there is no overlap between the brand’s description of the method of use protected by the patent … and the indications remaining in the generic’s proposed labelling,” it added.

It said that the court must take immediate intervention to avoid irreparable harm to the company, adding that the “market will be flooded immediately with generic version of Precedex”, and suggested that at least six months’ worth of the generic product will reach wholesale distribution channels.

One company has offered the Precedex generic at a price 45% lower than the current brand price, it said.

Yesterday, Mylan announced the launch of a dexmedetomidine hydrochloride injection. Quoting figures by IMS Health, it said that the dexmedetomidine hydrochloride injection had US sales of about $156.2 million in the 12 months to June 30, 2014.