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Vanda Pharmaceuticals Responds to Ruling in HETLIOZ® ANDA Appeal
WASHINGTON, May 10, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today responded to the ruling in its Hetlioz® Abbreviated New Drug
About this update from Vanda Pharmaceuticals Inc.
[{"type":"text","content":"WASHINGTON, May 10, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today responded to the ruling in its Hetlioz® Abbreviated New Drug Application appeal.\nToday a three-judge panel of the United States Court of Appeals for the Federal Circuit issued a written opinion that affirmed a December 13, 2022, decision of the United Sates District Court for the District of Delaware, which held that the asserted claims of Vanda's U.S. Patent Nos. RE46,604; 9,730,910; 10,149,829; and 10,376,487 are invalid.\nVanda is considering its options, including whether to request a rehearing.\nHETLIOZ® is also approved in the European Union and is not subject to this litigation, nor is generic litigation pending outside of the United States. The litigation does not relate to the HETLIOZ LQ® oral suspension formulation.\nAbout Vanda Pharmaceuticals Inc.\nVanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on Twitter @vandapharma.\nAbout HETLIOZ®\nFor full U.S. Prescribing Information for HETLIOZ®, including indication and Important Safety Information, visit www.hetlioz.com.\nCAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS\nVarious statements in this press release, including, but not limited to statements regarding Vanda's consideration of its options, are \"forward-looking statements\" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, whether Vanda will request a rehearing and whether such request is granted. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the var...