Full Press Release Details
Liquidia Corporation Provides Update on Litigation Filed by United
| New litigation filed against Liquidia in U.S. District Court for the Middle District of North Carolina alleges infringement of UTHR's 782 patent and seeks to enjoin Liquidia from commercializing YUTREPIA | ||
| 782 patent claims same general subject matter as UTHR's invalidated 793 patent | ||
| Does not impact FDA's ability to take final action on NDA for YUTREPIA on PDUFA goal date of May 24, 2025 |
MORRISVILLE, N.C., May 12, 2025 - Liquidia Corporation
(NASDAQ: LQDA), a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease, today announced
that United Therapeutics Corporation (UTHR) filed a complaint on May 9, 2025, in the U.S. District Court for the Middle District
of North Carolina (Case No. 1:25-cv-00368) against Liquidia alleging infringement of U.S. Patent No. 11,357,782 (the 782
patent). Additionally, the complaint seeks to enjoin Liquidia from commercializing YUTREPIA (treprostinil) inhalation powder if
approved by the U.S. Food and Drug Administration (FDA) to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated
with interstitial lung disease (PH-ILD).
Dr. Roger Jeffs, CEO, Liquidia said: "We are not surprised
by UTHR's repeated, last-minute attempts to deny PAH and PH-ILD patients access to an alternative therapy. We have invalidated similar
claims covering the treatment of pulmonary hypertension patients with inhaled treprostinil in the past and will continue to defend the
rights of patients suffering with these critical illnesses to choose the therapy that works best for them."
The 782 patent, which issued on June 14, 2022, arises out
of the same patent family as U.S. Patent No. 10,716,793 (the 793 patent) and claims the same general method of administering
inhaled treprostinil to pulmonary hypertension patients. As disclosed in July 2022, the 793 patent was held to be invalid
in a proceeding before the Patent Trial and Appeal Board (PTAB). The PTAB's decision was affirmed by the U.S. Court of Appeals
for the Federal Circuit in December 2023. The United States Supreme Court rejected UTHR's petition for a writ
of certiorari, thereby upholding PTAB's decision which found that all claims of the 793 patent are unpatentable due to prior
art as final and not subject to further appeal.
UTHR is currently not seeking any injunction against the FDA to prevent
final approval of the New Drug Application (NDA) for YUTREPIA. As previously announced, the FDA set a Prescription Drug User Fee Act (PDUFA)
goal date of May 24, 2025.
About Liquidia Corporation
Liquidia Corporation is a biopharmaceutical company developing innovative
therapies for patients with rare cardiopulmonary disease. The company's current focus spans the development and commercialization
of products in pulmonary hypertension and other applications of its proprietary PRINT Technology. PRINT enabled the creation of
Liquidia's lead candidate, YUTREPIA (treprostinil) inhalation powder, an investigational drug for the treatment of pulmonary
arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The company is also developing
L606, an investigational sustained-release formulation of treprostinil administered twice-daily with a next-generation nebulizer, and
currently markets generic Treprostinil Injection for the treatment of PAH. To learn more about Liquidia, please visit www.liquidia.com.
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press release may include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All
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Chief Business Officer
Director, Corporate Communications