TOKYO, January 4, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) confirmed the Court of Appeals for the Federal Circuit (CAFC) affirmed the earlier decision by the U.S. District Court for the District of Delaware that all asserted claims of the patents for LEXISCAN® (regadenoson injection) 0.4 mg/mL are not infringed by Hospira, Inc.
On December 6, 2022, the CAFC heard oral arguments, and the Temporary Stay preventing Hospira, Inc. from launching its generic expired. The CAFC also denied our motion for an Injunction pending appeal. The CAFC issued its decision affirming the earlier District Court decision on December 30, 2022.
Astellas is evaluating its legal options. We are also reviewing the potential financial impact for the fiscal year ending March 31, 2023.
For more information, please see the press release issued on May 20, 2022, and the press release issued on September 26, 2022.
Click below for a copy of the full press release