Astellas Pharma Inc. has confirmed that the U.S. District Court for the District of Delaware has issued a Report and Recommendation advising against granting Astellas’ motion for a preliminary injunction. This motion sought to prevent Lupin and Zydus from introducing their generic versions of MyrbetriqTM until the resolution of ongoing patent litigation involving Astellas’ U.S. Patent No. 11,707,451 (referred to as the ‘451 patent). Astellas intends to file objections to this Report. In July 2023, Astellas initiated this lawsuit in the U.S. District Court for the District of Delaware, alleging that the generic versions of MyrbetriqTM from Zydus and Lupin infringe the ‘451 patent.
Additionally, Astellas is involved in separate patent litigation against Zydus and Lupin, asserting that their versions of MyrbetriqTM infringe Astellas’ U.S. Patent No. 10,842,780. This case is presently pending at the Court of Appeals for the Federal Circuit (CAFC).
Astellas is currently assessing the potential financial impact of a launch at risk on its fiscal year forecast, scheduled to be disclosed on April 25, 2024.
About Astellas Astellas Pharma Inc. operates as a pharmaceutical company across more than 70 countries globally. The company is committed to the Focus Area Approach, aimed at continuously developing new drugs to address diseases with significant unmet medical needs by focusing on Biology and Modality. Moreover, Astellas is expanding beyond its foundational Rx focus to create Rx+® healthcare solutions, combining its expertise with cutting-edge technology from external partners. Through these endeavors, Astellas is at the forefront of healthcare innovation, translating innovative science into value for patients. For further details, visit the website: https://www.astellas.com/en.
Cautionary Notes This press release contains forward-looking statements regarding Astellas’ future performance, including current plans, estimates, strategies, and beliefs. These statements are based on management’s current assumptions and involve known and unknown risks and uncertainties that could cause actual results to differ materially. Factors such as changes in economic conditions and regulations, currency fluctuations, delays in product launches, and intellectual property infringements by third parties may affect these results. The information regarding pharmaceutical products in this press release does not constitute advertising or medical advice.
