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TOKYO, May 20, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today confirmed the U.S. District Court for the District of Delaware ruling that all asserted claims of the 8,106,183; 8, 524,883; and RE47301 patents for LEXISCAN® regadenoson injection) 0.4 mg/mL are not infringed. The patent infringement trial involved one Abbreviated New Drug Application (ANDA) filer, Hospira, Inc. Hospira is requesting permission from FDA to manufacture and commercialize a generic LEXISCAN® product before expiration of the LEXISCAN® patents. Astellas plans to appeal the decision and to take legal action to prevent Hospira from launching generic LEXISCAN® pending resolution of the appeal.
Astellas is reviewing the potential financial impacts of this district court decision for the fiscal year ending March 31, 2023.
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