Liquidia Updates on Hatch-Waxman Lawsuit Over ‘327 Patent

KUALA LUMPUR, 1 OCTOBER 2026 —

Liquidia Faces Legal Setback Over YUTREPIA Patent as U.S. Court Rules Against Drug’s PH-ILD Indication

The decision, issued September 30, 2026, leaves Liquidia preparing for appeals while United Therapeutics pushes for injunctive relief that could restrict YUTREPIA’s availability, with financial and operational repercussions looming for the company and its regional partners.

The ruling marks a critical escalation in a high-stakes Hatch-Waxman Act dispute that could reshape Liquidia’s commercial strategy for YUTREPIA, its lead product approved in 2025 for both pulmonary arterial hypertension (PAH) and PH-ILD. While the court invalidated the remaining claims of the ‘327 patent, the validity of claims 1 and 14—covering inhaled treprostinil formulations for PH-ILD patients—now exposes Liquidia to potential remedies ranging from label restrictions to outright market bans.

The company has one week to propose remedies with United Therapeutics, with the court expected to issue a final judgment shortly.

Liquidia’s CEO, Roger Jeffs, immediately signaled defiance, stating the company “respectfully disagrees” with the ruling and will pursue all appellate options. The firm also reaffirmed its plan to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to remove PH-ILD from YUTREPIA’s label—a move first announced in earlier filings. “Our commitment to patients remains unwavering,” Jeffs said, though the legal and regulatory hurdles ahead remain formidable.

United Therapeutics, which markets the competing Tyvaso® inhalation solution, has already filed post-trial briefs seeking injunctive relief to block YUTREPIA’s sale for PH-ILD, a demand that could force Liquidia to withdraw the indication entirely or face litigation-induced market withdrawal.

The financial stakes are substantial. YUTREPIA, developed using Liquidia’s proprietary PRINT® technology, generated early commercial traction after its 2025 approval, with analysts projecting its PH-ILD indication could contribute meaningfully to revenue—particularly in markets where interstitial lung disease (ILD) complicates pulmonary hypertension treatment. However, the court’s decision introduces uncertainty over the drug’s future, with potential outcomes including: - Label restrictions: Removal of PH-ILD from YUTREPIA’s approved uses, limiting its addressable patient population.

- Injunctive relief: A court-ordered halt to sales for PH-ILD, forcing Liquidia to either comply or appeal. - Regulatory delays: Extended FDA reviews of the sNDA, further postponing clarity on the drug’s commercial path.

Liquidia’s stock (NASDAQ: LQDA) has already faced volatility amid the litigation, with investors scrutinizing the company’s ability to sustain YUTREPIA’s market position. The firm’s broader pipeline—including L606, an investigational extended-release treprostinil formulation, and its generic Treprostinil Injection—offers some diversification, but YUTREPIA remains its flagship product. The legal battle also underscores the competitive intensity in the pulmonary hypertension space, where United Therapeutics holds a dominant position with Tyvaso® and Remodulin®.

For Malaysia and Southeast Asia, where respiratory diseases including ILD are increasingly recognized as public health priorities, the outcome could have indirect implications. Liquidia has not yet disclosed plans for regional commercialization of YUTREPIA, but if the PH-ILD indication is stripped or delayed, it may affect future market entry strategies.

Local stakeholders, including pulmonary specialists and patient advocacy groups, may monitor the case closely, particularly if YUTREPIA’s PRINT technology—engineered for precise lung deposition—could offer advantages over existing therapies in Asia’s diverse patient populations.

The next critical phase will unfold in the coming weeks, as Liquidia and United Therapeutics submit proposed remedies to the court. The company’s decision to appeal—expected given Jeffs’ statement—could prolong the uncertainty, with appeals potentially extending into 2027. Meanwhile, the FDA’s review of Liquidia’s sNDA to remove PH-ILD from the label will be a pivotal moment, as it could either resolve the dispute or deepen the legal and commercial fallout.

For now, the ruling leaves Liquidia at a crossroads: defend its patent position through appeals or pivot strategically to mitigate the risk of losing a key market segment for YUTREPIA.

Related: Roger Jeffs