---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-091806"
form_type: "8-K"
ticker: "LQDA"
cik: "0001819576"
company_name: "Liquidia Corp"
filed_at: "2024-08-22T23:59:59+00:00"
generated_at: "2026-05-31T08:06:53.958545+00:00"
event_type: "litigation"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Liquidia sues FDA over Tyvaso DPI exclusivity blocking YUTREPIA approval

## Summary
- FDA granted tentative approval of YUTREPIA on Aug 16, 2024, but final approval delayed until after May 23, 2025.
- Liquidia filed suit in D.C. District Court (Case No. 1:24-cv-02428) challenging FDA's 3-year NCI exclusivity for Tyvaso DPI.
- United Therapeutics voluntarily dismissed its complaint challenging FDA's acceptance of Liquidia's amended NDA on Aug 20.
- Liquidia argues FDA's decision violates congressional intent and seeks to vacate exclusivity to allow timely market entry.

## SEC filing metadata
- accession: 0001104659-24-091806
- form_type: 8-K
- ticker: LQDA
- cik: 0001819576
- company_name: Liquidia Corp
- filed_at: 2024-08-22T23:59:59+00:00
- event_type: litigation
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1819576/000110465924091806/0001104659-24-091806-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1819576/000110465924091806/tm2422418d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-091806
- JSON: https://secwatch.observer/filing/0001104659-24-091806.json
- Plain text: https://secwatch.observer/filing/0001104659-24-091806.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.