Dive Brief:
- A federal judge has temporarily blocked enforcement of the FDA's decision to allow manufacturers to create a generic version of Hospira's IV sedative Precedex, Reuters reports.
- On Monday, the FDA announced that manufacturers could make and sell Precedex as long as they did not include certain Hospira-patented uses for the medication in their labels. Hospira filed a federal suit seeking a temporary restraining order against generic manufacturers the following day.
- Precedex sales made up more than 10% of Hospira's global $4.1 billion earnings in 2013. Mylan Inc., a company hoping to make Precedex generics, sided with the FDA in the lawsuit while Novartis-affiliated generic maker Sandoz took Hospira's side. Sandoz reportedly worked out a six-month market exclusivity deal for Precedex with Hospira last year.
Dive Insight:
Mylan Inc., a company hoping to make Precedex generics, sided with the FDA in the lawsuit while Novartis-affiliated generic maker Sandoz took Hospira's side. Sandoz reportedly worked out a six-month market exclusivity deal for Precedex with Hospira last year.
U.S. District Judge Jarrod Hazel didn't mince words in his decision, asserting that the FDA's decision would do Hospira great financial harm amounting to "tens of millions of dollars" in losses. Hazel also said he expects Hospira to win its suit since he considers the FDA's decision "tantamount to a change of the rules." Hospira had threatened to slash its U.S. workforce if the FDA's decision were allowed to stand.