BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company that plans to change its name to BeOne Medicines Ltd., has announced a settlement agreement with MSN Pharmaceuticals, Inc. and MSN Laboratories Private Ltd. to resolve patent litigation over MSN’s Abbreviated New Drug Application (ANDA) for a generic version of BRUKINSA® (zanubrutinib) in the U.S.
Under the terms of the settlement, MSN will not be allowed to sell a generic version of BRUKINSA before June 15, 2037, though this date may be adjusted based on certain circumstances. The composition of matter patent for BRUKINSA, which expires in April 2034, was not contested by MSN in the litigation.
“BRUKINSA, developed in-house, is a leading BTK inhibitor with the most extensive label in its class globally. This settlement reinforces our confidence in the intellectual property protecting this groundbreaking therapy and its exclusivity. Approved in over 70 markets for treating various B-cell malignancies, BRUKINSA is a testament to the strength of our R&D program and our dedication to providing transformative medicines worldwide,” said Chan Lee, General Counsel at BeiGene. “We continue to advance innovative oncology treatments, relying on a strong patent system to protect our investments. Our focus remains on expanding access to this therapy and future innovations for cancer patients around the world.”
The settlement resolves all patent litigation initiated by BeiGene against companies attempting to market generic versions of BRUKINSA. Additionally, BeiGene and Sandoz Inc. previously agreed to dismiss patent litigation related to Sandoz’s ANDA for a generic version of BRUKINSA.
The Company also recently announced plans to change its name to BeOne, signaling its ongoing commitment to developing innovative medicines to eliminate cancer and partnering with the global community to reach as many patients as possible.
