Patent Protection Extended to 2037! BeiGene and MSN Pharmaceuticals Settle Lawsuit Over Zanubrutinib Generic

According to foreign media ENDPOINTSNEWS, BeiGene announced today that it has reached a settlement with MSN Pharmaceuticals regarding the patent lawsuit over the generic version of Zanubrutinib.

Under the terms of the agreement, MSN agrees not to sell a generic version of Zanubrutinib until June 15, 2037, a date more than three years later than the expiration of the drug’s substance patent in April 2034. MSN did not challenge the substance patent of Brukinsa in the lawsuit. 

BeiGene stated that Zanubrutinib is the company’s internally developed, best-in-class BTK inhibitor, with the broadest range of approved indications globally. This settlement further reaffirms the company’s confidence in protecting the intellectual property and exclusivity of this groundbreaking therapeutic drug. 

Zanubrutinib (Brukinsa) has been involved in multiple patent infringement disputes. Previously, BeiGene and generic drug giant Sandoz submitted a joint agreement to withdraw the patent lawsuit seeking approval for Sandoz to sell a generic version of Zanubrutinib. This settlement resolves all patent lawsuits that BeiGene had filed against companies seeking to sell a generic version of Zanubrutinib.

On November 12, BeiGene released its Q3 2024 earnings report, which revealed that global sales of its core product, Zanubrutinib, reached $690 million in Q3, approximately 4.91 billion RMB. Sales in the U.S. amounted to $504 million, an 87% increase compared to the previous year! As of the first three quarters, global sales of Zanubrutinib totaled $1.816 billion. If this growth trend continues, Zanubrutinib’s annual sales may exceed $2.5 billion! 

Currently, Zanubrutinib has been approved in over 70 markets worldwide and is the only BTK inhibitor to show superior efficacy results compared to Ibrutinib in head-to-head trials, making it the product with the widest range of indications in its class. In terms of competitive landscape among similar drugs, publicly available data shows that as of the first half of 2024, the global market share of the first-generation BTK inhibitor, Ibrutinib, has dropped to around 50%. As a second-generation BTK inhibitor, Zanubrutinib is continuously gaining market share due to its “best-in-class” efficacy and safety advantages. 

Especially in the U.S., Zanubrutinib's market share has grown significantly. According to Tianfeng Securities Research Institute, Zanubrutinib has doubled its market share in the U.S. within just one year, increasing from 19.07% in Q3 2023 to 37.81% in Q3 2024, showing rapid market expansion. Additionally, Zanubrutinib currently leads in the treatment of newly diagnosed patients in first-line and relapsed/refractory CLL, as well as all other approved B-cell malignancy indications.

In the increasingly competitive global pharmaceutical market, innovative drugs are a driving force behind the development of the pharmaceutical industry. Research and development companies face unprecedented challenges and opportunities, with the importance of intellectual property protection becoming ever more prominent. This settlement marks an important step for BeiGene in protecting the intellectual property of its innovative drugs, and it also provides a solid foundation for the company to expand Brukinsa’s accessibility globally.