华海药业「普瑞巴林胶囊」ANDA获美国暂时性批准

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Time of issue:2017-12-20 14:21
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(Summary description)12月12日，华海药业发布公告称，向美国FDA申报的「普瑞巴林胶囊」的ANDA已获得暂时批准(暂时批准：指FDA已经完成仿制药安全性和有效性审评，但由于专利权或专卖权未到期而给予的一种批准形式)。　　药品的基本情况：　　1、药物名称：普瑞巴林胶囊　　2、ANDA号：207883　　3、剂型：胶囊剂　　4、规格：25mg、50mg、75mg、100mg、150mg、200mg、225mg、300mg

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华海药业「普瑞巴林胶囊」ANDA获美国暂时性批准

Categories:最新消息
Author:
Origin:
Time of issue:2017-12-20 14:21
Views:

Information

　　12月12日，华海药业发布公告称，向美国FDA申报的「普瑞巴林胶囊」的ANDA已获得暂时批准(暂时批准：指FDA已经完成仿制药安全性和有效性审评，但由于专利权或专卖权未到期而给予的一种批准形式)。

　　药品的基本情况：

　　1、药物名称：普瑞巴林胶囊

　　2、ANDA 号：207883

　　3、剂型：胶囊剂

　　4、规格：25mg、50mg、75mg、100mg、150mg、200mg、225mg、300mg

　　5、申请事项：ANDA(美国新药简略申请)

　　6、申请人：普霖斯通制药有限公司(Prinston Pharmaceutical, Inc.)

　　截至目前，华海药业在普瑞巴林胶囊研发项目上已投入研发费用约650万元人民币。

　　原研药信息：

　　普瑞巴林胶囊由Pfizer研发，主要用于治疗带状疱疹后神经痛，于2005年在美国上市。美国境内，普瑞巴林胶囊生产厂商目前为 Pfizer;国内目前生产厂家有重庆赛维药业有限公司等。据统计，2016年普瑞巴林胶囊美国市场销售额约43亿美元，国内市场的销售额约人民币1.74亿元。原研企业化合物专利到期时间为2018年12月30日。

　　目前辉瑞公司针对普瑞巴林缓释片已经在美国和和中国都申请了相关制剂专利，分别为US20060555988和CN200680041140.7。该缓释制剂与CN200680041140.7中所述的固体药物组合物相比有很大区别，CN200680041140.7中的赋形剂包含基质形成剂和溶胀剂，所述基质形成剂包含聚醋酸乙烯酯和聚乙烯基吡咯烷酮，溶胀剂包含交联聚乙烯基吡咯烷酮。而该缓释制剂中的赋形剂主要包含溶胀剂和骨架材料，溶胀剂包含聚氧乙烯与交联聚乙烯基吡咯烷酮，骨架材料包含海藻酸钠。

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Electronic Arts pledges free use for five accessibility patents

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