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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 Seeking Approval To Market A Generic Version Of Brukinsa (Zanubrutinib)...

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 Seeking Approval To Market A Generic Version Of Brukinsa (Zanubrutinib)...

百濟神州已與MSN製藥和MSN實驗室私下達成和解協議,解決了與MSN的簡化新藥申請有關的專利訴訟,MSN在該申請中尋求批准上市布爾科尼薩(Zanubrutinib)的仿製版本。
Benzinga ·  11/19 19:08

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 Seeking Approval To Market A Generic Version Of Brukinsa (Zanubrutinib) In US

百濟神州已與MSN製藥和MSN實驗室私人達成和解協議,解決了與MSN的縮短新藥申請有關的專利訴訟,MSN尋求批准在美國市場上銷售Brukinsa(Zanubrutinib)的仿製版。

  • 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.
  • The settlement resolves all patent litigation brought by BeiGene against companies that sought to market generic versions of BRUKINSA. BeiGene and Sandoz Inc. 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.
  • 根據協議條款,MSN將不能在2027年6月15日之前出售BRUKINSA的仿製版,具體情況下可能根據某些習慣情況進行加速或延期。BRUKINSA的物質專利將在2034年4月到期,MSN在訴訟中沒有挑戰該專利。
  • 該和解解決了百濟神州對那些尋求市場BRUKINSA仿製版的公司提起的所有專利訴訟。百濟神州和諾華公司之前已聯合提交一份解除百濟神州提出的專利訴訟的書面聲明,作爲對諾華申請批准銷售BRUKINSA仿製版的回應。

譯文內容由第三人軟體翻譯。


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