Thursday in U.S. District Court in Delaware, in United’s original patent case against Liquidia, Judge Richard Andrews removed an injunction that had prohibited the FDA from approving Yutrepia. United has appealed the decision. A day later, in federal court in Washington, D.C., Judge John Bates denied a motion for a temporary restraining order in litigation filed by United against the FDA. The new version of Tyvaso was approved in May of 2022 and accounted for 59% ($731 million) of the franchise's sales of $1.23 billion last year. Tyvaso DPI sparked United to a company record of $2.33 billion in revenue in 2023, a 20% increase from 2022. The FDA accepted Liquidia’s application for a dry powder version of treprostinil in 2020 and then rejected it with a complete response letter seven months later. A year later, the FDA granted tentative approval to Yutrepia. That prompted United to sue the FDA, claiming that the regulator allowed Liquidia to sidestep “rules, precedents and procedures” in accepting the amendment. United contended that the FDA should have required Liquidia to submit an entirely separate application to treat PH-ILD. “Our commercial team is fully prepared to launch Yutrepia in both PAH and PH-ILD should the FDA grant final approval," Roger Jeffs, CEO of Liquidia, said in a release. "Once launched, we are confident that Yutrepia’s convenient, low-effort delivery and wide dosing range will propel the therapy towards our goal of establishing Yutrepia as the prostacyclin of first choice.” United did not respond immediately to a request for comment.
The company has filed an additional lawsuit against Liquidia in federal court in Delaware alleging that Yutrepia would infringe a patent that was issued in November of last year. United has filed for another preliminary injunction in that case which would prevent Liquidia from launching Yutrepia for PH-ILD.