Liquidia loses court challenge to FDA's Tyvaso DPI exclusivity; cross claim still pending

Liquidia Corp

On Feb 27, 2025, District Court denied Liquidia's summary judgment motion, affirming FDA's 3-year exclusivity for Tyvaso DPI.
Exclusivity expiration remains May 23, 2025; decision does not change that date.
United Therapeutics' cross claim challenging FDA's acceptance of Liquidia's amended NDA remains pending; dismissal motions not yet ruled on.
Liquidia filed lawsuit in August 2024; this ruling is a legal setback for their NDA approval timeline.

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