Liquidia Provides Update on Hatch-Waxman Litigation Tied to ‘327 Patent
Key Highlights
- ➤Claims 1 and 14 of Liquidia’s (LQDA) ‘327 patent were ruled valid and infringed
- ➤Four remaining asserted claims were found invalid
- ➤Judgment remedy proposals due to District Court within one week
- ➤Potential remedies include removing PH-ILD indication or broader YUTREPIA availability restrictions
- ➤Liquidia (LQDA) plans FDA label supplement and intends to pursue appeals
Expert Statements
Roger Jeffs, Chief Executive Officer of Liquidia
“We respectfully disagree with the Court’s decision regarding claims 1 and 14 and are fully prepared to pursue all available appellate options. As previously communicated to the Court, we intend to submit a supplement to YUTREPIA’s New Drug Application to the FDA to remove PH-ILD from the label. Our commitment to patients remains unwavering.”
* District Court ruled that two of the six claims asserted against Liquidia are valid and infringed * Parties directed to submit form of judgment, specifying the proposed remedy, for the District Court’s consideration within one week MORRISVILLE, N.C., Sept. 30, 2026 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company driven by science and compassion to revolutionize care for patients with challenging respiratory and vascular diseases, today issued an update regarding the litigation filed by United Therapeutics Corporation (UTHR) in the U.S. District Court for the District of Delaware (the Court) under the Hatch-Waxman Act concerning U.S. Patent No. 11,826,327 (‘327 patent) and the Company’s lead product, YUTREPIA(®) (treprostinil) inhalation powder.
Today, the Court ruled that claims 1 and 14 of the ‘327 patent, which generally cover the treatment of pulmonary hypertension with interstitial lung disease (PH-ILD) patients with inhaled treprostinil, including dry powder formulations of inhaled treprostinil, are valid and infringed by Liquidia. The remaining claims of the ‘327 patent that were asserted against Liquidia were found to be invalid. The parties have been directed to submit to the Court a form of judgment, which will specify the parties’ proposed remedies for infringing such claims, within one week.
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