BeOne Medicines settles litigation against generic filer of Brukinsa

25 November 2024

Sino-American oncology company BeOne Medicines (HKEX), until now known as BeiGene, has entered into a settlement agreement with MSN Pharmaceuticals and MSN Laboratories Private resolving patent litigation related to MSN’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Brukinsa (zanubrutinib) in the USA.

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.

Third-quarter 2024 UUS sales of Brukinsa totaled $504 million, representing growth of 87% over the prior-year period, with more than 60% of the quarter over quarter demand growth coming from expanded use in chronic lymphocytic leukemia (CLL).

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