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Vanda Pharmaceuticals Responds to Ruling in HETLIOZ® ANDA Litigation
WASHINGTON, Dec. 13, 2022 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today responded to the ruling in its HETLIOZ® ANDA Litigation.
About this update from Vanda Pharmaceuticals Inc.
[{"type":"text","content":"WASHINGTON, Dec. 13, 2022 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today responded to the ruling in its HETLIOZ® ANDA Litigation.\nVanda has brought several Hatch-Waxman lawsuits in the United States District Court for the District of Delaware against Teva Pharmaceuticals USA, Inc. (Teva) and Apotex Inc. (Apotex) asserting infringement of patents covering HETLIOZ® (tasimelteon) 20 mg capsules. A trial was held in March 2022. Today the Court ruled that Teva and Apotex did not infringe U.S. Patent No. RE46,604, and that the asserted claims of U.S. Patent Nos. RE46,604; 9,730,910; 10,149,829; and 10,376,487 are invalid. Vanda intends to appeal the decision to the United States Court of Appeals for the Federal Circuit and to request a stay of market entry by Teva and Apotex while the appeal is pending. \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.Vanda 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®For full U.S. Prescribing Information for HETLIOZ® and HETLIOZ LQ®, including indication and Important Safety Information, visit www.hetlioz.com.\nCAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTSVarious statements in this press release, including, but not limited to statements regarding Vanda's intention to appeal the decision and request a stay of market entry, 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 appeals the decision and Vanda's ability to obtain a stay of market entry. Therefore, ...