艾伯维(ABBV.US)与仿制药企业就核心免疫药物Rinvoq达成和解

智通财经2025-09-12

智通财经APP获悉，艾伯维公司(AbbVie，ABBV.US)于周四宣布，已与所有涉诉仿制药企业达成和解，解决了针对“仿制药企业计划推出Rinvoq仿制药”的相关诉讼。Rinvoq是艾伯维免疫治疗产品线中的核心药物。此前，这些仿制药企业已向美国食品药品监督管理局(FDA)提交了“简化新药申请”(Abbreviated New Drug Application，ANDA)，寻求推出这款关节炎治疗药物...

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Application，ANDA)，寻求推出这款关节炎治疗药物的非专利版本(即仿制药)。艾伯维在一份监管文件中表示，得益于此次达成的和解协议与授权协议，预计在2037年4月之前，针对Rinvoq片剂的仿制药不会进入美国市场。这家总部位于美国伊利诺伊州北芝加哥的制药巨头，已将Rinvoq及其“姊妹药”Skyrizi定位为重磅关节炎药物修美乐(Humira)的潜在替代产品。修美乐于2023年失去了美国市场的独占权(即专利保护到期，仿制药可合法进入)。2025年上半年，Rinvoq的净销售额达到27亿美元，同比增长约53%;与之形成对比的是，同期修美乐在美国市场的销售额同比下滑约63%。","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"corporation","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":1,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; 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