United Therapeutics moves to block Liquidia's PH-ILD product with preliminary injunction and FDA suit

UNITED THERAPEUTICS Corp

Filed preliminary injunction motion in Delaware on Feb 26, 2024, alleging Liquidia's PH-ILD product infringes U.S. Patent No. 11,826,327 (expires 2042).
Separately sued FDA in D.C., arguing Liquidia must submit a new NDA for PH-ILD, which would trigger a 30-month stay.
Liquidia's inhaled treprostinil is tentatively approved for PAH but not PH-ILD; United's Tyvaso is approved for both PAH and PH-ILD.
If injunction or stay granted, Liquidia cannot market its product for PH-ILD while patent litigation proceeds.

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