Hospira scores temporary win in lawsuit versus FDA

August 22, 2014

Precedex, dexmedetomidine hydrochloride, is approved to sedate patients with breathing tubes in an intensive-care setting, as well as patients without breathing tubes before and during surgeries and other procedures. Hospira’s patent that covers the use of Precedex in an intensive-care setting in due to expire in 2019, however other patents have already expired. On Monday, the FDA approved the sale of generic copies of the drug as long as the companies leave out information from the prescribing labels about uses that are covered under Hospira’s patent, including “intensive-care unit sedation.”

Precedex, dexmedetomidine hydrochloride, is approved to sedate patients with breathing tubes in an intensive-care setting, as well as patients without breathing tubes before and during surgeries and other procedures. Hospira’s patent that covers the use of Precedex in an intensive-care setting in due to expire in 2019, however other patents have already expired. On Monday, FDA approved the sale of generic copies of the drug as long as the companies leave out information from the prescribing labels about uses that are covered under Hospira’s patent, including “intensive-care unit sedation.”

The pharmaceutical company filed a lawsuit Tuesday asking for a temporary restraining order against FDA, stating that FDA’s decision to allow generic manufacturing of Precedex would violate Hospira’s patent. Precedex accounts for about 11% of the company’s $4 billion of annual sales. Hospira said in its lawsuit that it would lose “tens of millions of dollars” if FDA’s decision was not overturned.

US District Judge Jarrod Hazel ruled in favor of Hospira and said that allowing such a change could cause people to lose faith in the process for approving drugs. The judge also initially ordered FDA to recall any generic Precedex that was already sold or distributed, however he suspended that portion of his order on Wednesday. The pharmaceutical company, Mylan, began shipping generic Precedex on Monday and sided with FDA in the lawsuit, arguing that it would be harmed by a temporary restraining order.

A drug company in favor of the restraining order, Sandoz Inc., was set to start selling generic Precedex in December under a settlement with Hospira; the company expected to have the exclusive right to sell the generic drug for 6 months. Sandoz intervened in the lawsuit, stating that it would be wrongly deprived of the 6-month exclusivity period if FDA’s decision was not suspended.  

Judge Hazel found that any harm to Mylan or FDA “would pale in comparison” to the harm Hospira would suffer without the restraining order. Following the ruling, Hospira said that further court proceedings are expected in the next few days.

 

Erin Bastick is a PharmD Candidate 2016, Ohio Northern University, Ada, Ohio, and an inpatient intern at University Hospitals, Cleveland.