TOKYO, September 26, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) confirms the U.S. District Court for the District of Delaware’s order granting an interim injunction enjoining Hospira from launching its generic version of LEXISCAN® until October 5, 2022. The District Court, however, denied Astellas’ request for a Preliminary Injunction while Astellas’ appeal is pending with the Court of Appeals for the Federal Circuit (CAFC). Astellas is filing a Motion for Preliminary Injunction with the CAFC to prevent Hospira from launching generic LEXISCAN® until the CAFC resolves Astellas’ pending appeal of the district court decision.
On May 19, 2022, the U.S. District Court for the District of Delaware issued its decision that all of the 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. Astellas appealed this decision with the CAFC on June 1, 2022.
Astellas is reviewing the potential financial impacts of this district court decision for the fiscal year ending March 31, 2023.
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