Astellas Confirms Unfavorable District Court Decision in LEXISCAN® 0.4mg/mL U.S. Patent Trial

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. Click below for a copy of the full press release Astellas Confirms Unfavorable District Court Decision in LEXISCAN ® 0.4mg/mL U.S. Patent Trial

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