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news.Mallinckrodt has announced that its subsidiary, Cadence Pharmaceuticals, has entered into settlement and license agreements with Fresenius Kabi USA, resolving pending patent litigation involving OFIRMEV (acetaminophen) injection.
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The companies are not disclosing specific terms of the settlement and license agreements, except that Cadence has granted Fresenius Kabi a non-exclusive right to market an intravenous acetaminophen product in the U.S. under Fresenius Kabi’s 505(b)(2) New Drug Application on December 6, 2020, or earlier under certain circumstances.
Mallinckrodt’s subsidiary Cadence has two patents covering OFIRMEV listed in the Orange Book, the last of which, U.S. Patent No. 6,992,218, will expire on June 6, 2021. Cadence had filed suit against Fresenius Kabi in January 2013.
Other details of the settlement are confidential, and the settlement is subject to submission to the Federal Trade Commission and the U.S. Department of Justice. The settlement and license agreements will become effective upon the entry by the U.S. District Court of an order dismissing with prejudice the litigation with respect to Fresenius Kabi.
"This settlement validates our confidence in the strength and integrity of the intellectual property covering OFIRMEV," said Mark Trudeau, President and CEO, Mallinckrodt. "OFIRMEV represents a powerful growth product in our expanding portfolio, and we look forward to continuing the strong presence that has been established by this brand in the hospital market."
OFIRMEV® (acetaminophen) injection is indicated for the management of mild to moderate pain, management of moderate to severe pain with adjunctive opioid analgesics, and reduction of fever.