Apotex推出西格列汀片及西格列汀盐酸二甲双胍片,符合180天共享独占期资格

美股速递
Jun 03

Apotex公司已正式推出西格列汀片以及西格列汀与盐酸二甲双胍的复方片剂。根据相关法规,这两款仿制药产品有资格获得180天的市场共享独占期。

这一独占期安排意味着,在特定条件下,Apotex作为首仿药申请者,可在180天内与原创药企共同分享市场,而无须立即面对其他仿制药的完全竞争。西格列汀是一种用于治疗2型糖尿病的DPP-4抑制剂,其原研药由{"MRK":{"name_zh":"默沙东","name_en":"Merck"}}公司开发并销售。

此次仿制药的上市,预计将为糖尿病患者提供更多治疗选择,并可能通过市场竞争影响药品定价。符合共享独占期资格,是Apotex在仿制药申报和审批流程中取得的一个重要里程碑。

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