Liquidia Corp loses FDA lawsuit; Tyvaso DPI exclusivity stands

Published 28/02/2025, 13:06
Liquidia Corp loses FDA lawsuit; Tyvaso DPI exclusivity stands

Liquidia Corporation, a pharmaceutical company based in Morrisville, North Carolina, with a market capitalization of $1.3 billion, faced a legal setback on Thursday when the U.S. District Court for the District of Columbia ruled against the company in its lawsuit challenging the U.S. Food and Drug Administration’s (FDA) decision to grant regulatory exclusivity to Tyvaso DPI, a product of United Therapeutics (NASDAQ:UTHR) Corporation. According to InvestingPro data, the company maintains strong financial health with a current ratio of 6.33, indicating robust short-term liquidity despite this legal challenge.

The court’s decision, dated February 27, 2025, denied Liquidia’s motion for summary judgment and simultaneously granted summary judgment motions filed by the FDA and United Therapeutics, upholding the FDA’s award of a three-year clinical investigation exclusivity to Tyvaso DPI. Despite the unfavorable ruling for Liquidia, the regulatory exclusivity period for Tyvaso DPI is still set to expire on May 23, 2025.

Additionally, United Therapeutics had filed a cross claim in the same litigation, challenging the FDA’s acceptance of Liquidia’s amended New Drug Application (NDA) for review. Liquidia became a party to this cross claim on November 5, 2024, and both Liquidia and the FDA have submitted motions to dismiss United Therapeutics’ claim. The court has yet to decide on these motions, and they remain unaffected by the court’s recent decision.

Liquidia’s lawsuit was an attempt to contest the FDA’s grant of exclusivity to Tyvaso DPI, which had implications for the company’s ability to compete in the market. The court’s ruling is based on the legal proceedings and filings as per the SEC documentation.

This report is based on statements from a press release and does not include any speculative or subjective commentary. The information is presented to provide a clear and factual account of the legal outcomes and their immediate implications for the involved parties. For deeper insights into Liquidia’s financial health and market position, including detailed analyst recommendations and comprehensive valuation metrics, visit InvestingPro.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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