--- title: "Court denies Liquidia's challenge to FDA exclusivity for Tyvaso DPI" url: "https://aibio.space/news/court-denies-liquidias-challenge-fda-exclusivity-tyvaso-dpi/" publisher: "aibio.space (Biotech Investor Relations News)" date: "2025-02-28" section: "Legal" tickers: "NASDAQ:LQDA" source: "https://www.sec.gov/Archives/edgar/data/1819576/000110465925018635/tm257909d1_8k.htm" summary: "A federal judge in Washington denied Liquidia's summary judgment motion on February 27, 2025, upholding the FDA's three-year exclusivity for United Therape" --- By the aibio.space news desk. Sources - [Liquidia Corp Form 8-K filed February 28, 2025 (SEC EDGAR)](https://www.sec.gov/Archives/edgar/data/1819576/000110465925018635/tm257909d1_8k.htm) - [Liquidia Corp Form 10-K filed March 13, 2024: business overview and signatures (SEC EDGAR)](https://www.sec.gov/Archives/edgar/data/1819576/000155837024003051/lqda-20231231x10k.htm) [LQDA](https://aibio.space/companies/liquidia/) 2025-02-28 # Court denies Liquidia's challenge to FDA exclusivity for Tyvaso DPI Tickers [LQDA](https://aibio.space/companies/liquidia/) A federal judge in Washington denied Liquidia's summary judgment motion on February 27, 2025, upholding the FDA's three-year exclusivity for United Therapeutics' Tyvaso DPI. The exclusivity still ends May 23, 2025, and a related cross claim remains pending. ## Key facts - **Company**: Liquidia Corporation (NASDAQ: LQDA) - **News type**: Legal - **Primary source**: [Liquidia Corp Form 8-K filed February 28, 2025 (SEC EDGAR)](https://www.sec.gov/Archives/edgar/data/1819576/000110465925018635/tm257909d1_8k.htm) *A columned courthouse. Photo: Carol M Highsmith, CC0, via rawpixel. The picture shows the field, not the companies named.* A federal court has ruled against Liquidia Corporation (Nasdaq: [LQDA](https://aibio.space/companies/liquidia/)) in its lawsuit challenging the FDA's grant of regulatory exclusivity to Tyvaso DPI. Liquidia disclosed in a [Form 8-K](https://www.sec.gov/Archives/edgar/data/1819576/000110465925018635/tm257909d1_8k.htm) filed February 28, 2025 that the US District Court for the District of Columbia denied its motion for summary judgment on February 27, 2025. The court granted the summary judgment motions of the US Food and Drug Administration (FDA), the agency whose decision Liquidia sued over, and of United Therapeutics Corporation, which holds the Tyvaso DPI exclusivity and filed its own motion and a cross claim in the case. The 8-K does not use the word defendant for either. ## What the lawsuit challenges Liquidia filed the suit on August 21, 2024 under Case No. 1:24-cv-02428. It challenged the FDA's decision to grant three years of new clinical investigation exclusivity, which the company calls regulatory exclusivity, to Tyvaso DPI. The filing calls the case the FDA Litigation. The court agreed to an expedited summary judgment schedule and held a hearing on December 5, 2024. In its February 27, 2025 decision it affirmed the FDA's award. The company says the ruling does not change the date the exclusivity ends, which is still May 23, 2025. Exclusivity matters because it can keep a competing product off the market for a set period. The filing does not say what Liquidia plans to do when the period ends on May 23, 2025. ## The cross claim United Therapeutics filed its own cross claim in the same case. It challenges the FDA's acceptance of Liquidia's amended New Drug Application for review. Liquidia intervened and became a party to the cross claim on November 5, 2024. Liquidia and the FDA each filed motions to dismiss the cross claim. Those motions are still pending, and the company says the February 27, 2025 decision does not affect them. The filing does not say when the court will rule on those motions. ## The company's position Liquidia describes itself, in its [annual report for 2023](https://www.sec.gov/Archives/edgar/data/1819576/000155837024003051/lqda-20231231x10k.htm), as a biopharmaceutical company that develops, manufactures and commercializes products for unmet patient needs. Its focus is rare cardiopulmonary diseases, including pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. The lead candidate is YUTREPIA, an inhaled dry powder treprostinil made with its PRINT particle engineering platform. The FDA tentatively approved the New Drug Application for YUTREPIA for PAH in November 2021, and Liquidia filed an amendment in July 2023 to add PH-ILD to the label. The annual report describes that approval as tentative. The filing does not say when full approval would come. The 2023 report says Liquidia's revenue comes in part from a promotion agreement with Sandoz Inc., dated August 1, 2018, under which the two companies share profit from Sandoz's generic treprostinil injection in the United States. The report also lists L606, a liposomal treprostinil licensed from Pharmosa, as an investigational product. Liquidia's chief financial and operating officer, Michael Kaseta, signed the 8-K. The annual report is signed by Chief Executive Officer Roger A. Jeffs, Ph.D. ## Losses and other disputes The 2023 report shows a net loss of $78.5 million for 2023, up from $41.0 million in 2022, and an accumulated deficit of $429.1 million as of December 31, 2023. The fight with United Therapeutics is not limited to this case. In December 2021 United Therapeutics sued Liquidia and a former United Therapeutics employee in the Superior Court in Durham County, North Carolina, alleging that they conspired to misappropriate trade secrets. Those claims are allegations, and the report says that case was still pending. The ruling leaves Liquidia without the result it sought. The 8-K does not say whether Liquidia will appeal the February 27 decision. [Report an error](https://aibio.space/reputation/#correction) ## Companies in this story LQDA Liquidia Corporation NASDAQ ยท United States Open the starter desk ## More in Legal Legal ### [Alnylam details Texas patent suit, two Cipla patent cases and a U.S. Attorney subpoena](https://aibio.space/news/alnylam-details-texas-patent-suit-two-cipla-patent-cases-u-s-attorney/) Oct 29, 2026 Legal ### [Viking and Ligand dispute VK2809 license termination in San Diego court](https://aibio.space/news/viking-ligand-dispute-vk2809-license-termination-san-diego-court/) Oct 29, 2026 Legal ### [Viking's ITC trade secret ruling against Ascletis is on appeal at Federal Circuit](https://aibio.space/news/vikings-itc-trade-secret-ruling-against-ascletis-appeal-federal/) Oct 29, 2026 --- Source page: https://aibio.space/news/court-denies-liquidias-challenge-fda-exclusivity-tyvaso-dpi/. Facts in aibio.space stories are checked against company filings and releases; opinion is labelled. Cite as: aibio.space, "Court denies Liquidia's challenge to FDA exclusivity for Tyvaso DPI", 2025-02-28, https://aibio.space/news/court-denies-liquidias-challenge-fda-exclusivity-tyvaso-dpi/