Pfizer, Astellas, and University of California Sue Qilu Pharma Over Xtandi Patent Infringement

Pfizer Inc. (NYSE: PFE), through its subsidiary Medivation, and co-development partner Astellas Pharma Inc. (TYO: 4503), are stepping up their efforts to safeguard the intellectual property of their blockbuster prostate cancer drug, Xtandi (enzalutamide). In a joint legal action with the University of California, the companies have filed a lawsuit in the U.S. against China-based Qilu Pharmaceutical Co., Ltd., alleging patent infringement. The lawsuit claims that Qilu’s proposed generic version of enzalutamide infringes upon U.S. Patent Nos. 7,709,517 and 11,839,689.

The University of California, the original creator of enzalutamide, licensed the patent to Medivation and Medivation Prostate Therapeutics, with Pfizer subsequently sublicensing it exclusively to Astellas. In the U.S., Xtandi is marketed collaboratively by Medivation and Astellas, while Astellas solely manages the product’s marketing outside the U.S. This legal move follows a previous lawsuit filed by Pfizer/Medivation/Astellas against India’s Sun Pharma in 2022, which resulted in an out-of-court settlement in October 2023. The three Orange Book-listed patents for Xtandi are not set to expire until 2027 at the earliest. Astellas reported that Xtandi generated JPY 661 billion (USD 4.8 billion) in revenue during the fiscal year ending March 2023.- Flcube.com

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