BeiGene announced a settlement agreement with MSN Pharmaceuticals and MSN Laboratories Private, resolving litigation over MSN’s attempt to market a generic version of Brukinsa (zanubrutinib) in the U.S.
Under the settlement, MSN is prohibited from selling a generic version before June 15, 2037, with potential adjustments based on specific conditions. The composition of the matter patent for Brukinsa, which expires in April 2034, was not contested.
The agreement concludes all patent litigation involving Brukinsa generics. BeiGene had previously resolved a similar case with Sandoz, which filed an Abbreviated New Drug Application (ANDA) seeking approval to market a generic drug version. These settlements secure Brukinsa market exclusivity as a BTK inhibitor, approved in more than 70 markets for treating various B-cell malignancies.
BeiGene recently announced plans to rebrand as BeOne Medicines, reflecting its mission to develop innovative oncology treatments and broaden access to patients worldwide. The company continues to focus on delivering transformative medicines and advancing its research and development pipeline.
Brukinsa is among BeiGene’s leading therapies, with its intellectual property protections reinforcing the company’s efforts to maintain exclusivity.