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TRENTON — A federal judge on Thursday rejected drugmaker Wyeth's request for a temporary restraining order to block a rival from selling a generic version of a lucrative Wyeth antibiotic.
The move comes after Wyeth sued the Food and Drug Administration Wednesday.
Wyeth wants the FDA to reverse its Sept. 16 approval of a generic version of Zosyn, an intravenous antibiotic often given to critically ill patients. Wyeth argues patient safety is at stake.
The Madison, N.J.-based company asked the U.S. District Court in Washington, D.C., to issue a temporary restraining order or an injunction barring Orchid Chemicals & Pharmaceuticals Ltd. from selling its product.
But the federal court denied the restraining order.
"Wyeth has failed to demonstrate a likelihood of success on the merits," District Judge Ellen Segal Huvelle wrote in the ruling.
She said Wyeth had submitted about 400 pages of documents to the court alleging that FDA had acted illegally in approving a generic version of Zosyn based on an older, inferior formulation Wyeth no longer makes.
Wyeth has argued that the generic version could mix with other IV solutions, triggering a chemical reaction that inactivates the antibiotic and endangering patients. Wyeth said having two versions in use could confuse hospital workers. Huvelle wrote that the warning on the generic product would be adequate.
Issuing a restraining order would "impose significant economic harm" on Orchid, she wrote, because the company has a 180-day period of exclusivity as the maker of the only generic version on the market.
"It is far from clear on the record that the denial of a TRO will cause irreparable harm to the plaintiff or the public," Huvelle wrote.
Meanwhile, Orchid issued a statement Thursday saying that before Wyeth had filed its motion, its generic products were launched in the U.S. through its distribution partnership with Canada's Apotex Inc.
Huvelle noted in her ruling that during a conference call with the parties late Wednesday, Apotex officials said the product likely "would be in use in hospitals within days." That led Wyeth officials to ask the court for an immediate temporary restraining order, which she denied.
"We're still going to trial and we intend on pursuing this case vigorously," Wyeth spokeswoman Natalie de Vane said Thursday.
Zosyn, launch in 1993, is Wyeth's fifth best-selling drug, with revenue of about $1.3 billion.
