Astellas Confirms Unfavorable District Court Decision in LEXISCAN U.S. Patent Trial

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Astellas Pharma, today, confirmed the Unfavorable District Court Decision in the LEXISCAN U.S. Patent Trial. Recently, the U.S. District Court for the District of Delaware ruled out 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 the expiration of the LEXISCAN® patents. 

Astella is planning to appeal the decision and to take legal action to prevent Hospira from launching generic LEXISCAN® pending resolution of the appeal. The pharma firm is also reviewing the potential financial impacts of this district court decision for the fiscal year ending March 31, 2023. 

Lexiscan is a pharmacologic agent used in a cardiac nuclear stress Case. The drug works by increasing blood flow in the coronary arteries. It is given prior to a myocardial perfusion imaging (MPI) test, which provides physicians with detailed information about blood flow into a patient’s heart.

Due to medical issues, almost half of those who undertake a cardiac stress test are unable to use a treadmill or stationary bicycle.  Lexiscan can be used when a person is unable to exercise enough to enhance blood flow to the heart during a cardiac nuclear stress test.

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