BeiGene Secures Long-Term Protection for BRUKINSA with Patent Settlement Until 2037

Settlement Agreement:
BeiGene has entered into a settlement agreement with MSN Pharmaceuticals, resolving patent litigation related to MSN's attempt to market a generic version of BRUKINSA (zanubrutinib) in the U.S.123.

Market Exclusivity:
Under the agreement, MSN cannot sell a generic version of BRUKINSA before June 15, 2037, subject to potential acceleration or extension under certain customary circumstances123.

Composition Patent:
The composition of matter patent for BRUKINSA, expiring in April 2034, was not challenged by MSN in the litigation123.

Global Approval:
BRUKINSA, a BTK inhibitor, is approved in over 70 markets for treating diverse B-cell malignancies and has the broadest label in its class globally14.

Legal Victory:
The settlement represents a significant legal victory for BeiGene, securing BRUKINSA's market exclusivity until 2037 and strengthening its market position13.

Revenue Implications:
The extended protection period allows for continued market penetration and revenue growth without generic competition pressure, positively impacting BeiGene's long-term revenue prospects13.

Intellectual Property:
The settlement reaffirms BeiGene's confidence in the intellectual property protecting BRUKINSA and its exclusivity, underscoring the strength of its R&D program14.

Previous Litigation:
The settlement resolves all patent litigation brought by BeiGene against companies seeking to market generic versions of BRUKINSA, including a previous dismissal with Sandoz Inc.123.

Sources:

1. https://www.stocktitan.net/news/BGNE/bei-gene-announces-settlement-of-litigation-against-generic-filer-of-866jm16qe1sr.html

2. https://www.moomoo.com/news/post/46053433/beigene-has-entered-into-a-settlement-agreement-with-msn-pharmaceuticals

3. https://www.investing.com/news/sec-filings/beigene-settles-patent-litigation-extends-brukinsa-exclusivity-93CH-3729614

4. https://ir.beigene.com/news/beigene-announces-settlement-of-litigation-against-generic-filer-of-brukinsa/dab29bac-73b6-46e4-b531-01d811d75b69/