BRIEF— Astellas gets unfavorable District Court decision in Lexiscan patent dispute

Japanese drug major Astellas Pharma has confirmed the US 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) 0.4mg/mL are not infringed.

The patent infringement trial involved one Abbreviated New Drug Application (ANDA) filer, Hospira, which is requesting permission from Food and Drug Administration 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.