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A federal judge dealt a major blow to Liquidia, ruling that its dry-powder lung drug Yutrepia infringes a key United Therapeutics patent covering inhaled treprostinil for pulmonary hypertension-associated interstitial lung disease (PH-ILD). Liquidia's shares plunged nearly 50%, while United Therapeutics' stock surged 12.3%. Liquidia says it will appeal and plans to ask the FDA to remove the PH-ILD indication from Yutrepia's label.
A federal judge in Delaware handed United Therapeutics a decisive win in its patent dispute with rival Liquidia, ruling that Liquidia's dry-powder inhaled drug Yutrepia infringes two foundational claims of United Therapeutics' '327 patent. The patent protects methods of treating pulmonary hypertension-associated interstitial lung disease (PH-ILD) using inhaled treprostinil — the same active ingredient in United Therapeutics' blockbuster drug Tyvaso.
The ruling effectively clouds Yutrepia's path to competing in the PH-ILD market. Liquidia CEO Roger Jeffs pushed back, saying the company "respectfully disagrees" with the decision and plans to pursue all appellate options. The company also intends to ask the FDA to strip the PH-ILD indication from Yutrepia's label. A final judgment is expected within about a week.
By the Numbers:
Why it matters: This ruling reinforces patent protections for United Therapeutics' Tyvaso franchise and significantly limits near-term competition in the PH-ILD treatment space — a condition with few therapeutic options — with major implications for patients, payers, and the broader pulmonary hypertension market.