Nov 19, 2024 6:00 AM--SAN MATEO, Calif.--(BUSINESS WIRE)-- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company which intends to change its name to BeOne Medicines Ltd., today announced it has entered into a settlement agreement with MSN Pharmaceuticals, Inc. and MSN Laboratories Private Ltd. resolving patent litigation related to MSN’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of BRUKINSA® (zanubrutinib) in the U.S.
Under the terms of the agreement, MSN will not be able to sell a generic version of BRUKINSA earlier than June 15, 2037, subject to potential acceleration or extension under certain customary circumstances. The composition of matter patent for BRUKINSA, expiring in April 2034, was not challenged by MSN in the litigation.
“Developed internally, BRUKINSA is a best-in-class BTK inhibitor with the broadest label of any medicine in its class globally. This settlement reaffirms our confidence in the intellectual property protecting this groundbreaking treatment and its exclusivity. Approved in over 70 markets for treating diverse B-cell malignancies, BRUKINSA exemplifies the strength of our R&D program and reinforces our commitment to delivering transformative medicines around the world,” said Chan Lee, General Counsel at BeiGene. “We continue to advance our innovative oncology treatments, relying on a robust patent system to safeguard our investment. Our focus remains on expanding access to this therapy and future innovations for cancer patients globally.”
The settlement resolves all patent litigation brought by BeiGene against companies that sought to market generic versions of BRUKINSA. BeiGene and Sandoz Inc. previously filed a joint stipulation to dismiss patent litigation brought by BeiGene in response to Sandoz’s ANDA seeking approval to market a generic version of BRUKINSA.
The Company recently announced its intent to change its name to BeOne, reaffirming its commitment to develop innovative medicines to eliminate cancer by partnering with the global community to serve as many patients as possible.
About BeiGene
BeiGene, which plans to change its name to BeOne Medicines, is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of nearly 11,000 colleagues spans five continents.