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# Liquidia Sues FDA Over Tyvaso’s Exclusivity
- URL: https://www.fdaweb.com/liquidia-sues-fda-over-tyvasos-exclusivity/
- Published: 2024-08-22T12:00:00.000Z
- Updated: 2026-09-14T14:39:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157637

Liquidia Corp. has filed a lawsuit against FDA over the agency’s recent decision to grant United Therapeutics Corp. (UTC) an additional three-year exclusivity period for Tyvaso DPI (treprostinil), which blocks Liquidia’s Yutrepia (treprostinil) from entering the market before 5/23/2025\. Treprostinil is indicated for treating pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.

“FDA’s action is contrary to law and arbitrary and capricious,” the [complaint](http://www.fdaweb.com/download.php?file=liquidia%5F8-21-2024.pdf) says. “It improperly allows UTC to maintain its decades-long monopoly in violation of clear congressional intent permitting exclusivity only in strictly limited circumstances involving innovation. FDA exceeded its statutory mandate by improperly crediting a single study that fails to justify any exclusivity at all, and by granting UTC broad exclusivity for far more than the ‘innovation’ the study purportedly covered, encompassing unstudied indications, patient populations, drug-device combination products, and formulations.”

The complaint asks that FDA’s exclusivity decision be vacated, and that final approval be granted for Liquidia’s Yutrepia, which currently sits as being tentatively approved.