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Yutrepia patients with PH-ILD can stay on their inhaler as the indication comes off the label

Yutrepia PH-ILD patients already on the inhaler can keep it after Liquidia's settlement with United Therapeutics, but new PH-ILD patients should not start.

HNHealthcare News

People already on Yutrepia for PH-ILD, a form of pulmonary hypertension tied to interstitial lung disease, can stay on it, but United Therapeutics says new PH-ILD patients should not start it. Liquidia said on November 10, 2026 that it is asking the FDA to drop PH-ILD from the label under its patent settlement with United Therapeutics.

Key points

  • Liquidia and United Therapeutics signed a global settlement on October 13, 2026 that ended all six lawsuits between them.
  • Liquidia says Yutrepia stays available without disruption and that no patient has to stop treatment.
  • The company has filed a Prior Approval Supplement with the FDA to remove PH-ILD from Yutrepia's label and has stopped promoting the drug for that use.
  • Liquidia will pay a net $380.7 million in installments across 2026 and 2027, a sum that also covers parties to separate antitrust litigation against United Therapeutics.
  • Yutrepia net product sales reached $222.7 million in the third quarter of 2026, up 31% from the second quarter.

What does the Yutrepia PH-ILD label change mean for patients?

For patients already on Yutrepia, the change is about the label and marketing, not access. Liquidia says nobody on Yutrepia has to come off it, and the drug remains approved and sold for pulmonary arterial hypertension (PAH).

United Therapeutics, the other party to the settlement, gave clinicians one more instruction in its own October 14 statement: the agreement keeps therapy going for every PAH and PH-ILD patient already on Yutrepia, and, effective immediately, Yutrepia should not be prescribed to new PH-ILD patients (United Therapeutics statement, October 14, 2026).

The settlement came two weeks after a September 30 ruling in the U.S. District Court for the District of Delaware, which found certain claims of U.S. Patent No. 11,826,327 valid and infringed. According to United Therapeutics' filing with the SEC, that patent covers improving exercise capacity in PH-ILD patients by inhaling treprostinil at specific doses, and it runs until February 3, 2042 (United Therapeutics Form 8-K). Liquidia agreed not to appeal, and the settlement includes mutual releases with no admission of liability by either side.

Yutrepia is a dry-powder form of treprostinil taken through a small handheld inhaler. The FDA granted it full approval in May 2025, and Liquidia began shipping it in the United States the following month.

Why does inhaled treprostinil matter in PH-ILD?

Inhaled treprostinil has placebo-controlled trial evidence in PH-ILD, a condition that had no approved therapy before 2021. In the INCREASE trial, 326 patients with interstitial lung disease and pulmonary hypertension were randomized to nebulized treprostinil or placebo, and after 16 weeks the treated group walked 31.12 meters farther in a six-minute walk test than the placebo group (Waxman et al., NEJM, 2021).

The same study found clinical worsening in 22.7% of treated patients against 33.1% on placebo, and NT-proBNP, a marker of heart strain, fell 15% with treprostinil while rising 46% with placebo (Waxman et al., NEJM, 2021). The trial is registered as NCT02630316.

Liquidia puts U.S. PH-ILD prevalence above 60,000 patients and notes that the condition had no approved treatment until inhaled treprostinil was cleared for it in March 2021.

What did Liquidia report for the third quarter?

Liquidia reported a third-quarter net loss of $236.3 million, driven by a $389.7 million charge for the settlement. Without that charge, the company says adjusted EBITDA rose for a fifth straight quarter, to $140.5 million.

Yutrepia sales were $222.7 million for the quarter, against $51.7 million a year earlier. Liquidia counted 1,300 prescribers through October and says total patient shipments in October were the highest of any month since launch. More than 70% of September referrals included a PAH diagnosis, according to the company. Cash and cash equivalents stood at $396.1 million on September 30, before any settlement payments, which Liquidia expects to fund from that cash and from Yutrepia sales.

The settlement figures fit together this way. The $389.7 million charge combines $330.4 million owed to United Therapeutics, less $10.0 million United Therapeutics owes Liquidia, $60.3 million owed to parties in the separate antitrust case, and some non-cash write-offs; the cash items net to the $380.7 million Liquidia will pay.

Is Liquidia still developing treatments for PH-ILD?

Yes: Liquidia's PH-ILD work continues through L606, a separate liposomal treprostinil suspension given twice a day with a nebulizer. Re-Spire, a global placebo-controlled pivotal study of L606 in PH-ILD, is enrolling, with enrollment expected to finish in 2028 and the primary study in 2029.

In PAH, Liquidia has started LTI-403, an open-label study of patients switching to Yutrepia from oral selexipag, and plans SPRINT and the EASY-PAH registry. The company is also testing Yutrepia in Raynaud's phenomenon linked to systemic sclerosis (SSc-RP). The FDA granted that program Fast Track designation in September 2026, and the first patient has enrolled in RE-WARM, a Phase 2 dose-finding study expected to reach primary completion in the first quarter of 2027.

What should pulmonary hypertension clinics take from this?

Our analysis: For clinics, the practical point is continuity for current patients and a different path for new ones. People with PH-ILD already on Yutrepia can stay on it, but new PH-ILD patients should not be started on it, and the drug's label and Liquidia's sales effort narrow to PAH. Liquidia's own PH-ILD ambitions now rest on L606, whose pivotal results are expected in 2029. For more on how late-stage programs are being designed, see our report on a Phase 3 lung cancer trial planned around brain metastases and our roundup on trends in new drug and therapy development.

Frequently asked questions

Is Yutrepia still approved for pulmonary arterial hypertension?

Yes. Liquidia says Yutrepia is approved and marketed for PAH, and the settlement does not change that.

Which patent was at the center of the Liquidia and United Therapeutics case?

U.S. Patent No. 11,826,327, which relates to treating PH-ILD with inhaled treprostinil. A Delaware federal court found certain of its claims valid and infringed on September 30, 2026.

When are Liquidia's remaining settlement payments due?

Of the $330.4 million owed to United Therapeutics, $185 million was due within 30 business days of the October 13 agreement, and the remaining $145.4 million is split into two installments of $72.7 million each, due on or before February 1, 2027 and April 30, 2027, according to United Therapeutics' Form 8-K.

Is Yutrepia approved for Raynaud's phenomenon in systemic sclerosis?

No. Liquidia says Yutrepia is not approved for SSc-RP; the FDA has given that use Fast Track designation, which can speed review, while the RE-WARM study runs.

Sources

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