August 19, 2014 / 8:15 PM / in 3 years

Hospira sues U.S. FDA over approval of generic sedative

(Reuters) - Drugmaker Hospira Inc has sued the Food and Drug Administration over its decision to open the doors for competitors to sell generic versions of its patented sedative, Precedex.

The suit, filed Tuesday in federal court in Maryland, claimed the FDA’s “arbitrary and capricious” decision on Monday effectively changed the rules for generic drugs while sidestepping the normal rule-making process.

Hospira is asking the court to issue a temporary restraining order blocking the sale of any generic Precedex. According to the suit, the FDA has already granted an application by one company, Par Sterile Products, to make the drug.

Hospira said it would lose “tens of millions of dollars” and be forced to lay off its entire U.S. brand drug sales force if the court did not grant the restraining order.

Precedex has two approved uses - sedating respirator patients in intensive care units and sedating patients for surgery or other procedures. Hospira holds a patent on the drug’s use for “intensive care unit sedation.”

In its ruling on Monday, the FDA said it can legally allow drug companies to sell generic Precedex as long as the label omits its indication for ICU respirator patients.

Hospira fired back in its suit that its patent covers any use of the drug in an ICU, whether for respirator patients or for surgery. It said the FDA was going against its own rules by allowing a generic drug for a use that partly overlaps with a patented purpose.

An FDA representative declined to comment.

A Hospira representative could not immediately be reached.

The case is Hospira v. Burwell, U.S. District Court, District of Maryland, No. 8:14-cv-02662.

Reporting By Brendan Pierson; Editing by Ted Botha and Andre Grenon

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