Judge Grants Temporary Stay On Sale Of Generic's Of Hospira's Precedex

(RTTNews) - Pharmaceutical and medication delivery company Hospira, Inc. (HSP) revealed in a regulatory filing on Wednesday that a federal judge has granted a temporary restraining order against the U.S. Food and Drug Administration or FDA's, decision to allow the sale of generic versions of its proprietary sedative drug Precedex (dexmedetomidine HCl injection).

Lake Forest, Illinois-based Hospira holds a patent on its flagship sedative Precedex relating to intensive care unit sedation which will expire only in 2019. However, the patent that covers use in patients without breathing tubes before and during surgeries and other procedures is said to have already expired.

The drug accounted for 11 percent of Hospira's global net sales of $4.1 billion in 2013, according to Hospira's recent annual report.

The FDA on Monday approved the generic versions for sale as long as the labels do not carry any information about the drug's use for intensive care unit sedation and contain information on only other indications of the drug.

U.S. District Judge George Jarrod Hazel on Tuesday stayed the FDA's decision to allow the sale of generic Precedex and also ordered the FDA to recall any product sold or distributed under its decision. The order is currently to remain in effect until September 2, unless extended, as court proceedings expected to occur over the next few days.

The judge said the potential harm suffered by Hospira from the immediate availability of generics would far exceed what would be suffered by the FDA or Mylan, Inc (MYL). Generic drug companies Mylan and Sandoz, Inc. were to gain by the FDA decision. Mylan had gained approval to sell the generic version of Precedex for the sedation of non-intubated patients preceding and/or during surgical and other procedures. Mylan launched its drug immediately after the FDA approval on Monday itself.

Sandoz, the generic arm of Swiss drugmaker Novartis AG (NVS), was also set to start selling the generic version of Precedex after reaching a settlement on a patent litigation with Hospira, which gave Sandoz an exclusive right to sell the generic drug for six months.

Hospira challenged the order and had sought a temporary restraining order in a lawsuit filed in U.S. District Court of Maryland on Tuesday against the FDA's decision. The company argued that FDA's decision to allow sale of the generic versions of Precedex was against its own rules and violates Hospira's patent.

Precedex is a relatively selective alpha2-adrenergic agonist indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting as well as for sedation of non-intubated patients prior to and/or during surgical and other procedures.

HSP closed Wednesday's regular trading session at $54.91, up $0.90 on a volume of 1.66 million shares.