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盐酸哌甲酯缓释片是一种中枢神经兴奋剂,主要用于治疗注意缺陷多动障碍。

米内网数据显示,盐酸哌甲酯缓释片已被纳入国家医保乙类目录,近年来在中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院(简称中国公立医疗机构)终端的销售额逐年上涨,2023年突破4亿元,2024上半年以约39%的增速继续增长。

近年来中国公立医疗机构终端盐酸哌甲酯缓释片销售情况(单位:万元)

来源:米内网中国公立医疗机构药品终端竞争格局

仿制药申报方面,立方制药的盐酸哌甲酯缓释片于近日顺利获批生产,拿下国内首仿+首家过评。目前暂无其他企业的产品以新注册分类报产,预计短时间内其厂家竞争格局不会发生变化。

2025年以来,立方制药有3个品种获批生产并视同过评,为盐酸哌甲酯缓释片、盐酸丙美卡因滴眼液、帕利哌酮缓释片,其中盐酸哌甲酯缓释片为国内首仿+首家过评,盐酸丙美卡因滴眼液为国产第4家获批且首家视同过评,帕利哌酮缓释片为公司获批的首款精神安定药。

目前立方制药还有6个品种以新注册分类申报上市/临床在审,包括加替沙星滴眼液(暂无企业过评或视同过评)、贝派度酸片(暂无首仿)、美阿沙坦钾片、洛索洛芬钠口服溶液、美沙拉秦肠溶片、马来酸噻吗洛尔滴眼液,涵盖心脑血管系统药物、神经系统药物、感觉系统药物等治疗领域。

立方制药以新分类申报且在审的品种

来源:米内网中国申报进度(MED)数据库

注:米内网《中国公立医疗机构药品终端竞争格局》,统计范围是:中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院,不含民营医院、私人诊所、村卫生室;上述销售额以产品在终端的平均零售价计算。数据统计截至4月15日,如有疏漏,欢迎指正!

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