{"id":13947,"date":"2024-11-21T14:00:02","date_gmt":"2024-11-21T06:00:02","guid":{"rendered":"https:\/\/flcube.com\/?p=13947"},"modified":"2025-01-06T18:14:26","modified_gmt":"2025-01-06T10:14:26","slug":"beigene-reaches-patent-settlement-with-msn-pharmaceuticals-for-brukinsa","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=13947","title":{"rendered":"BeiGene Reaches Patent Settlement with MSN Pharmaceuticals for Brukinsa"},"content":{"rendered":"\n

China-based BeiGene Ltd (NASDAQ: BGNE<\/a>; HKG: 6160<\/a>; SHA: 688235<\/a>), which is in the process of changing its name to BeOne Medicines Ltd, has announced a patent settlement agreement with MSN Pharmaceuticals, Inc. and MSN Laboratories Private Ltd. concerning its oncology drug Brukinsa (zanubrutinib). The agreement stipulates that MSN’s generic version of Brukinsa will not be marketed in the US until June 15, 2037, effectively resolving patent litigation with BeiGene over the Abbreviated New Drug Application (ANDA) for the copycat drug in the country. This settlement comes as the originator’s patent protection remains in effect until April 2034.<\/p>\n\n\n\n

Resolution of Patent Litigation and Its Impact<\/strong>
The agreement with MSN resolves all patent litigation initiated by BeiGene against companies aiming to launch generic versions of Brukinsa. This settlement follows a similar joint stipulation with Sandoz Inc., where both parties agreed to dismiss patent litigation in response to Sandoz’s filing for generic approval of Brukinsa, which included the Paragraph IV Certification (PIV). <\/p>\n\n\n\n

BeiGene’s Legal Actions Against Generic Competitors<\/strong>
In March of this year, BeiGene took legal action against MSN and Sandoz after both generic drug manufacturers filed ANDAs with the FDA seeking approval for generic versions of Brukinsa. These filings contained the Paragraph IV Certification, which is a challenge to the originator’s patents, prompting BeiGene’s legal response.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

China-based BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), which is in the process of…<\/p>\n","protected":false},"author":1,"featured_media":13950,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[61],"tags":[185,2092,847,2232,1408,846,3046,73,848],"class_list":["post-13947","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-legal-ip","tag-beigene","tag-beone-medicines","tag-hkg-6160","tag-msn-laboratories-private","tag-msn-pharmaceuticals","tag-nasdaq-bgne","tag-nasdaq-onc","tag-patents","tag-sha-688235"],"yoast_head":"\nBeiGene Reaches Patent Settlement with MSN Pharmaceuticals for Brukinsa - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), which is in the process of changing its name to BeOne Medicines Ltd, has announced a patent settlement agreement with MSN Pharmaceuticals, Inc. and MSN Laboratories Private Ltd. concerning its oncology drug Brukinsa (zanubrutinib). The agreement stipulates that MSN's generic version of Brukinsa will not be marketed in the US until June 15, 2037, effectively resolving patent litigation with BeiGene over the Abbreviated New Drug Application (ANDA) for the copycat drug in the country. This settlement comes as the originator's patent protection remains in effect until April 2034.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=13947\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"BeiGene Reaches Patent Settlement with MSN Pharmaceuticals for Brukinsa\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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