Astellas receives unfavourable decision in LEXISCAN(R) 0.4mg/mL US patent trial
23 May 2022 -

Japan-based Astellas Pharma Inc. (TSE: 4503) confirmed on Friday the US District Court for the District of Delaware ruling that all asserted claims of the 8,106,183+ADs- 8,524,883+ADs- and RE47301 patents for LEXISCAN(R) (regadenoson injection) 0.4mg/mL are not infringed.

The patent infringement trial involved one Abbreviated New Drug Application (ANDA) filer, US-based pharmaceutical and medical device company Hospira, Inc. According to Astellas, Hospira is requesting permission from the US Food and Drug Administration (FDA) to manufacture and commercialise a generic LEXISCAN(R) product before expiration of the LEXISCAN(R) patents. Astellas said that it plans to appeal the decision and to take legal action to prevent Hospira from launching generic LEXISCAN(R) pending resolution of the appeal.

Astellas said that it is reviewing the potential financial impacts of this district court decision for the fiscal year ending 31 March 2023.