Hospira sued the US Food and Drug Administration (FDA) in August 2014 over its decision to allow competitors, including Mylan, to sell generics of its patented sedative, Precedex. The suit, filed in federal court in Maryland, branded FDA’s decision to approve generics of Precedex ‘arbitrary and capricious’ because they said it ignored standard regulation in this area.

Hospira asked the court to put a temporary restraining order blocking the sale of any generic versions of Precedex. Hospira holds a method-of-use patent until 1 October 2019, which covers the use of Precedex in intensive care units (ICUs). Mylan and other generics companies claim that because their abbreviated new drug applications (ANDAs) specifically exclude the use of the drug in ICUs, they adhered to rules governing the so-called ‘section viii carve-out pathway’. The method-of-use that is patented for the brand-name drug (Precedex) has been carved out of the label for the generic drug.

The federal judge affirmed FDA’s decision to approve generics of the drug. Precedex has two approved uses – sedating respirator patients in ICUs and sedating patients for surgery or other procedures. Following the ruling, 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 had said it would lose ‘tens of millions of dollars’ and be forced to lay off its entire US brand-name drug sales force if the court did not grant the restraining order. FDA’s decision to accept the carve-out pathway for generics of Precedex will have significant implications for generics and brand-name drug manufacturers in the US.

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