Legal settlement secures long-term access to Yutrepia for PAH patients
Under agreement, the therapy will no longer be available for PH-ILD
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Liquidia and United Therapeutics have entered into a global settlement that ends a yearslong legal dispute over Yutrepia, Liquidia’s dry powder inhalation formulation of the medication treprostinil.
Under the settlement, Liquidia will maintain access to Yutrepia for people with pulmonary arterial hypertension (PAH), but pull the therapy from the market as an option for pulmonary hypertension associated with interstitial lung disease (PH-ILD).
Liquidia agrees not to appeal decision
The U.S. Food and Drug Administration (FDA) tentatively approved Yutrepia in 2021 as a treatment for PAH, which is marked by narrowing of the vessels that carry blood from the heart through the lungs. In 2024, the FDA extended the tentative approval to also cover PH-ILD, which is characterized by high pressure in the lung vessels of people with underlying diseases that cause lung scarring. In May 2025, the FDA gave full approval of Yutrepia for PAH and PH-ILD.
But even though the FDA agreed that Yutrepia had proven safe and effective as a treatment for both PAH and PH-ILD, long-term access to the therapy has been uncertain due to multiple lawsuits from United. These lawsuits alleged that Liquidia was infringing on intellectual property protections for Tyvaso, United’s inhalation formulation of treprostinil.
A few weeks ago, the U.S. District Court in Delaware issued a ruling in United’s favor, essentially saying that, by marketing Yutrepia, Liquidia was violating patents held by United that cover the use of inhaled treprostinil to treat PH-ILD. Under the settlement, Liquidia has agreed not to appeal that decision, and has submitted paperwork asking the FDA to remove PH-ILD as an approved indication on Yutrepia’s prescribing information.
This agreement preserves YUTREPIA as a treatment option for the PAH community without interruption and puts the litigation behind us.
Liquidia also agreed to pay United a total of $380.7 million in several installments, and to stop marketing Yutrepia for PH-ILD. However, the settlement will allow continued access to Yutrepia for people with PAH.
“This agreement preserves YUTREPIA as a treatment option for the PAH community without interruption and puts the litigation behind us. Liquidia can now focus its full attention on supporting patients and healthcare providers, advancing clinical research and generating additional evidence in PAH,” Roger Jeffs, PhD, Liquidia’s CEO, told Pulmonary Hypertension News.
Jason Adair, Liquidia’s chief business officer, noted that removing PH-ILD from Yutrepia’s label and not marketing the therapy for that condition “is solely the result of patent litigation. It does not relate to efficacy or patient safety and does not affect the use of YUTREPIA to treat patients with pulmonary arterial hypertension (PAH).”
Agreement provides certainty for PAH patients
The settlement ends a half-dozen ongoing lawsuits between the companies. The big takeaway, according to a press release from Liquidia, is that PAH patients on Yutrepia will maintain uninterrupted access to the therapy, without fear that access might stop due to legal issues.
“Today’s agreement fully resolves years of litigation and provides certainty to PAH patients that they can continue to access YUTREPIA, whose differentiated attributes have enabled its rapid adoption by physicians and patients since launch,” Jeffs added in the press release.
The end of the legal battle between Liquidia and United has been a major source of relief for Jen Cueva, who lives with PAH and writes the column Worth the PHight at Pulmonary Hypertension News. Cueva has written and spoken about her experiences with Yutrepia, including her anxiety about potentially losing access to a therapy that was helping her.
“After 21 years of living with PAH, adding Yutrepia has given me more energy, better endurance, and more good days. The uncertainty brought back fears from the hardest parts of my health journey. I was losing sleep, and my anxiety was through the roof,” said Cueva, who is manager of partnership relations at Bionews, the parent company of this site.
“Knowing access will continue for PAH patients brings tremendous relief to so many families, including mine,” she added. “I’m deeply grateful to everyone who watched my videos, listened to my story, and shared our message. Thank you for helping patients feel heard during such a frightening time.”
Gareth Gwyn, senior vice president of medical affairs at Liquidia, said that Cueva’s experience “represents the experiences of many other patients and families living with PAH …Â We hope this settlement brings relief to patients and families who have been worried about losing access and allows them to focus on their health.”
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