BeiGene (BGNE) has entered into a settlement agreement with MSN Pharmaceuticals and MSN Laboratories Private resolving patent litigation related to MSN’s Abbreviated New Drug Application 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. BeiGene and Sandoz 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.
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