{"id":1182,"date":"2018-01-08T14:17:04","date_gmt":"2018-01-08T06:17:04","guid":{"rendered":"https:\/\/clarivate.com\/tw\/2018\/01\/08\/%e5%ad%b8%e5%90%8d%e8%97%a5%e5%a4%96%e9%8a%b7%e8%88%87%e5%9c%8b%e9%9a%9b%e5%8c%96%e6%ba%96%e5%82%99-%e2%94%80-%e5%a6%82%e4%bd%95%e5%ae%8c%e6%95%b4%e7%9a%84%e8%92%90%e9%9b%86%e5%b0%8d%e7%85%a7%e8%97%a5\/?lang=zh-hant"},"modified":"2018-01-08T14:17:04","modified_gmt":"2018-01-08T06:17:04","slug":"generic-drug-globalization-how-to-collect-full-patent-portfolio","status":"publish","type":"post","link":"https:\/\/clarivate.com\/life-sciences-healthcare\/zh\/blog\/generic-drug-globalization-how-to-collect-full-patent-portfolio\/","title":{"rendered":"\u5b78\u540d\u85e5\u5916\u92b7\u8207\u570b\u969b\u5316\u6e96\u5099 \u2500 \u5982\u4f55\u5b8c\u6574\u7684\u8490\u96c6\u5c0d\u7167\u85e5\u54c1\u7684\u5c08\u5229\u6e05\u55ae"},"content":{"rendered":"<p><strong>2019.8.21\u66f4\u65b0<\/strong><\/p>\n<p>\u884c\u653f\u9662<a href=\"https:\/\/www.fda.gov.tw\/tc\/siteContent.aspx?sid=10982\" target=\"_blank\" rel=\"noopener noreferrer\">\u516c\u544a<\/a>\u5c08\u5229\u9023\u7d50\u5236\u5ea6\u65bc2019\u5e748\u670820\u65e5\u958b\u59cb\u65bd\u884c\uff0c\u904e\u53bb\u5148\u7533\u8acb\u85e5\u8b49\u5f8c\u518d\u8003\u616e\u662f\u5426\u7b49\u5f85\u5c08\u5229\u5230\u671f\u518d\u4e0a\u5e02\u7684\u4f5c\u6cd5\u4e5f\u9762\u81e8\u6311\u6230\u3002\u5b78\u540d\u85e5\u7522\u54c1\u7dda\u7684\u4f48\u5c40\u4e0d\u518d\u662f\u88ab\u52d5\u7684\u63a5\u6536\u5c08\u5229\u5230\u671f\u7684\u8a0a\u606f\uff0c\u82e5\u662f\u60f3\u63d0\u524d\u9032\u5165\u5e02\u5834\uff0c\u5728\u7522\u54c1\u6216\u7522\u54c1\u7d44\u5408\u898f\u5283\u6642\uff0c\u5c31\u8981\u958b\u59cb\u8003\u616e\u54ea\u4e9b\u5c08\u5229\u6703\u662f\u6211\u7684\u9032\u5165\u969c\u7919\uff1f\u8981\u5982\u4f55\u628a\u76f8\u95dc\u5c08\u5229\u67e5\u5168\uff1f\u7279\u5225\u662f\u6d89\u53ca\u7269\u8cea\u3001\u7d44\u5408\u7269\u6216\u914d\u65b9\u53ca\u91ab\u85e5\u7528\u9014\u7684\u5c08\u5229\u3002\u9664\u4e86\u7b49\u5f85\u539f\u5ee0\u85e5\u767b\u8a18\u7684\u5167\u5bb9\u5916\uff0c\u6709\u6c92\u6709\u5176\u4ed6\u63d0\u524d\u958b\u59cb\u6e96\u5099\u7684\u65b9\u6cd5\uff1f\u5e0c\u671b\u900f\u904e\u4ee5\u4e0b\u7684\u5167\u5bb9\u958b\u555f\u60a8\u53e6\u4e00\u7a2e\u601d\u8def\u3002<\/p>\n<p>&nbsp;<\/p>\n<hr \/>\n<p>\u4f5c\u8005\uff1a\u8d99\u5b87\u8587\uff08\u79d1\u777f\u552f\u5b89 \u751f\u547d\u79d1\u5b78\u89e3\u6c7a\u65b9\u6848\u9867\u554f\uff09<\/p>\n<p>&nbsp;<\/p>\n<p>\u5c0d\u8a31\u591a\u5b78\u540d\u85e5\u5ee0\u4f86\u8aaa\uff0c\u5c08\u5229\u4f55\u6642\u5230\u671f\u662f\u63a8\u4f30\u81ea\u5bb6\u7522\u54c1\u4e0a\u5e02\u7533\u8acb\u6642\u7a0b\u7684\u91cd\u8981\u56e0\u7d20\u4e4b\u4e00\u3002\u5c08\u5229\u9023\u7d50\u5236\u5ea6\u53ef\u63d0\u4f9b\u660e\u78ba\u7684\u5c08\u5229\u7d44\u5408\u4f9b\u5b78\u540d\u85e5\u6311\u6230\uff0c\u7136\u800c\u5c0d\u65bc\u5176\u4ed6\u5c1a\u672a\u65bd\u884c\u5c08\u5229\u9023\u7d50\u5236\u5ea6\u7684\u570b\u5bb6\u6216\u5730\u5340\uff08\u5982\u6771\u5357\u4e9e\uff09\uff0c\u539f\u958b\u767c\u5ee0\u7684\u65b0\u85e5\u548c\u5176\u76f8\u5c0d\u61c9\u7684\u5c08\u5229\u7d44\u5408\u5c31\u6c92\u6709\u50cf\u5728\u4f7f\u7528\u5c08\u5229\u9023\u7d50\u5236\u5ea6\u7684\u570b\u5bb6\u90a3\u9ebc\u660e\u78ba\u3002\u5168\u7403\u5b78\u540d\u85e5\u5e02\u5834\u60c5\u5831\u8cc7\u6599\u5eab <a href=\"https:\/\/clarivate.com\/cortellis\/zh-hant\/solutions\/generics-intelligence-analytics\/\" target=\"_blank\" rel=\"noopener\">Cortellis Generics Intelligence<\/a> \u53ef\u6709\u6548\u5354\u52a9\u5b78\u540d\u85e5\u5ee0\u8de8\u8d8a\u5c08\u5229\u672c\u8eab\u7528\u8a9e\u7684\u7279\u6b8a\u6027\u3001\u5404\u570b\u5c08\u5229\u8aaa\u660e\u66f8\u7684\u8a9e\u8a00\u9694\u95a1\u7b49\u6311\u6230\uff0c\u8b93\u8490\u96c6\u85e5\u54c1\u5c08\u5229\u60c5\u5831\u4efb\u52d9\u66f4\u70ba\u5b8c\u5584\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\u85c9\u7531\u5c08\u5229\u9023\u7d50\u5236\u5ea6\u63d0\u4f9b\u521d\u968e\u7684\u5c08\u5229\u6e05\u55ae<\/strong><\/h3>\n<p>\u7f8e\u570b\u57281984\u5e74Hatch-Waxman\u6cd5\u6848\u9812\u5e03\u5f8c\uff0c\u7533\u8acb\u4e0a\u5e02\u7684\u65b0\u85e5\u9700\u8981\u767b\u9304\u76f8\u61c9\u7684\u5c08\u5229\u8cc7\u8a0a\u5305\u62ec\u5c08\u5229\u865f\u3001\u5c08\u5229\u5230\u671f\u65e5\u7b49\u8a0a\u606f\u5728\u6a58\u76ae\u66f8\u4e0a\uff1b\u5728\u5b78\u540d\u85e5\u5ee0\u7533\u8acb\u7c21\u6613\u65b0\u85e5\u4e0a\u5e02\u7533\u8acb (ANDA) \u5f8c\uff0c\u82e5\u662f\u8981\u5728\u5c08\u5229\u4fdd\u8b77\u671f\u5167\u4e0a\u5e02\u7684\u5b78\u540d\u85e5\uff0c\u591a\u6578\u9078\u64c7\u6311\u6230\u65b0\u85e5\u539f\u5ee0\u5c08\u5229\uff0c\u5373 Paragraph IV \u7684\u8def\u5f91\u52a0\u901f\u4e0a\u5e02\uff1b\u7533\u8acb Paragraph IV \u4e0a\u5e02\u7684\u5b78\u540d\u85e5\u5ee0\u5fc5\u9808\u5728FDA\u63a5\u53d7\u7533\u8acb\u5f8c\u768420\u5929\u5167\u901a\u77e5\u539f\u958b\u767c\u85e5\u5ee0\uff0c\u800c\u539f\u958b\u767c\u85e5\u5ee0\u63a5\u7372\u901a\u77e5\u5f8c\u768445\u5929\u5167\u82e5\u63d0\u51fa\u5c08\u5229\u4fb5\u6b0a\u8a34\u8a1f\uff0c\u5247FDA\u5c07\u66ab\u505c\u5be9\u7406\u5b78\u540d\u85e5\u5ee0\u7684ANDA\u7533\u8acb30\u500b\u6708\uff0c\u5f85\u5c08\u5229\u4fb5\u6b0a\u722d\u8b70\u89e3\u6c7a\u621630\u500b\u6708\u5230\u671f\u5f8c\u624d\u7e8c\u884c\u85e5\u8b49\u5be9\u67e5\u7684\u7a0b\u5e8f\uff1b\u7136\u800c\u6b64\u5c08\u5229\u9023\u7d50\u5236\u5ea6\u4e26\u975e\u7368\u539a\u539f\u958b\u767c\u85e5\u5ee0\uff0c\u5c0d\u65bc\u9996\u5bb6\u6311\u6230\u6210\u529f\u7684\u5b78\u540d\u85e5\u5ee0\uff0c\u5247\u662f\u7d66\u8207180\u5929\u7684\u92b7\u552e\u5c08\u5c6c\u6b0a\u5229\uff0c\u4ee5\u9f13\u52f5\u5b78\u540d\u85e5\u63d0\u524d\u4e0a\u5e02\u3002<a href=\"https:\/\/www.mohw.gov.tw\/cp-3569-39059-1.html\" target=\"_blank\" rel=\"noopener noreferrer\">2017\u5e74\u5e95\u53f0\u7063\u85e5\u4e8b\u6cd5\u4fee\u6b63\u4e09\u8b80\u901a\u904e\uff0c\u5f15\u5165\u5c08\u5229\u9023\u7d50\u5236\u5ea6<\/a>\uff0c\u660e\u8a02\u65b0\u85e5\u8a31\u53ef\u8b49\u6301\u6709\u4eba\uff08\u5982\u539f\u958b\u767c\u85e5\u5ee0\u6216\u4ee3\u7406\u5546\uff09\u9700\u63d0\u5831\u7533\u8acb\u8a31\u53ef\u8b49\u85e5\u54c1\u7684\u7269\u8cea\u3001\u7d44\u5408\u7269\u6216\u914d\u65b9\u3001\u91ab\u85e5\u7528\u9014\u7684\u5c08\u5229\uff1b\u7576\u5b78\u540d\u85e5\u7533\u8acb\u4e0a\u5e02\u7d93\u885b\u751f\u4e3b\u7ba1\u6a5f\u95dc\uff08\u5982\u885b\u751f\u798f\u5229\u90e8\u98df\u54c1\u85e5\u7269\u7ba1\u7406\u7f72\uff0cTFDA\uff09\u5c31\u85e5\u54c1\u8a31\u53ef\u8b49\u7533\u8acb\u8cc7\u6599\u9f4a\u5099\u901a\u77e5\u9001\u9054\u6b21\u65e5\u8d7720\u5929\u5167\uff0c\u901a\u77e5\u65b0\u85e5\u8a31\u53ef\u8b49\u6301\u6709\u4eba\uff0c\u82e5\u6b64\u5b78\u540d\u85e5\u4e0a\u5e02\u7533\u8acb\u6709\u5c08\u5229\u4fb5\u6b0a\u7591\u616e\u6642\uff0c\u5c08\u5229\u6b0a\u4eba\u8981\u572845\u5929\u5167\u63d0\u51fa\u8a34\u8a1f\uff0c\u885b\u751f\u4e3b\u7ba1\u6a5f\u95dc\u53ef\u4ee5\u66ab\u505c12\u500b\u6708\u6838\u767c\u8a31\u53ef\u8b49\uff0c\u800c\u5c0d\u65bc\u9996\u5bb6\u5c08\u5229\u6311\u6230\u6216\u8ff4\u907f\u6210\u529f\u7684\u5b78\u540d\u85e5\u5ee0\u5247\u53ef\u7372\u5f9712\u500b\u6708\u7684\u5e02\u5834\u92b7\u552e\u5c08\u5c6c\u671f\u3002<\/p>\n<p>\u5c31\u5168\u7403\u5e02\u5834\u4f86\u770b\uff0c\u5c08\u5229\u9023\u7d50\u5236\u5ea6\u63d0\u4f9b\u660e\u78ba\u7684\u5c08\u5229\u7d44\u5408\u4f9b\u5b78\u540d\u85e5\u6311\u6230\uff0c\u76ee\u524d\u50c5\u6709\u5c11\u6578\u570b\u5bb6\uff0c\u5982\u7f8e\u570b\u3001\u5357\u97d3\u3001\u52a0\u62ff\u5927\u3001\u6fb3\u6d32\u53ca\u5373\u5c07\u65bd\u884c\u5c08\u5229\u9023\u7d50\u5236\u5ea6\u7684\u53f0\u7063\u6709\u76f8\u95dc\u898f\u5b9a\uff1b\u5f9e\u53e6\u4e00\u65b9\u9762\u4f86\u770b\uff0c\u5c0d\u65bc\u5176\u4ed6\u5c1a\u672a\u65bd\u884c\u5c08\u5229\u9023\u7d50\u5236\u5ea6\u7684\u570b\u5bb6\u6216\u5730\u5340\uff0c\u4f8b\u5982\u53f0\u7063\u85e5\u5ee0\u6d89\u8db3\u672a\u6df1\u7684\u6771\u5357\u4e9e\u570b\u5bb6\uff0c\u539f\u958b\u767c\u5ee0\u7684\u65b0\u85e5\u548c\u5176\u76f8\u5c0d\u61c9\u7684\u5c08\u5229\u7d44\u5408\u5c31\u6c92\u6709\u50cf\u5728\u4f7f\u7528\u5c08\u5229\u9023\u7d50\u5236\u5ea6\u7684\u570b\u5bb6\u90a3\u9ebc\u660e\u78ba\u3002\u5c31\u8b58\u5225\u539f\u958b\u767c\u5ee0\u65b0\u85e5\u7684\u5c08\u5229\u6aa2\u7d22\u4f86\u770b\uff0c\u8003\u91cf\u5c08\u5229\u672c\u8eab\u7528\u8a9e\u7684\u7279\u6b8a\u6027\uff0c\u5927\u90e8\u5206\u7684\u60c5\u6cc1\u4e26\u975e\u4ee5\u85e5\u540d\u6216\u85e5\u54c1\u6d3b\u6027\u6210\u5206 (API) \u540d\u7a31\u5c31\u53ef\u4ee5\u76f4\u63a5\u67e5\u8a62\u5230\u76f8\u95dc\u7684\u5c08\u5229\uff1b\u5176\u6b21\u8003\u91cf\u6771\u5357\u4e9e\u570b\u5bb6\u4e26\u975e\u4f7f\u7528\u7d71\u4e00\u8a9e\u8a00\uff0c\u4e14\u5c08\u5229\u8aaa\u660e\u66f8\u662f\u4ee5\u8a72\u570b\u5b98\u65b9\u8a9e\u8a00\u516c\u5e03\uff0c\u4ea6\u589e\u52a0\u5c08\u5229\u8abf\u67e5\u6642\u7684\u96e3\u5ea6\uff1b\u518d\u8005\uff0c\u9664\u8003\u91cf\u539f\u958b\u767c\u85e5\u5ee0\u7684\u5c08\u5229\u5916\uff0c\u5c0d\u65bc\u958b\u767c\u540c\u85e5\u54c1\u7684\u516c\u53f8\u5c08\u5229\u4f48\u5c40\uff0c\u4e5f\u61c9\u56b4\u8b39\u7684\u7d0d\u5165\u5c08\u5229\u8abf\u67e5\u7684\u7bc4\u570d\u3002<\/p>\n<p>\u4ee5\u809d\u764c\u6a19\u9776\u85e5\u7269\u857e\u838e\u74e6(Nexavar\u00ae, \u5176\u4e2d\u85e5\u7269\u6d3b\u6027\u6210\u4efd(API)\u70basorafenib)\u70ba\u4f8b\uff0c\u900f\u904e\u79d1\u777f\u552f\u5b89 <a href=\"https:\/\/clarivate.com\/cortellis\/zh-hant\/solutions\/generics-intelligence-analytics\/\" target=\"_blank\" rel=\"noopener\">\u5168\u7403\u5b78\u540d\u85e5\u5e02\u5834\u60c5\u5831\u8cc7\u6599\u5eab Cortellis Generics Intelligence<\/a> \u67e5\u8a62\uff0c\u53ef\u4ee5\u770b\u5230\u5728\u6536\u9304\u5728\u6a58\u76ae\u66f8\u4e0a\u7684\u5c08\u5229\u5217\u8868\u5305\u542b\uff1a\u5c08\u5229\u865f\u3001\u5c08\u5229\u6b0a\u4eba\u3001\u5c08\u5229\u5206\u985e\u4ee5\u53ca\u5c08\u5229\u7684\u5230\u671f\u65e5; \u82e5\u6a58\u76ae\u66f8\u4e0a\u7684\u5c08\u5229\u906d\u9047\u5c08\u5229\u6311\u6230 \uff08patent challenge\uff0c\u5c24\u5176\u662f\u6307 Pharagraph IV\u7684\u5c08\u5229\u6311\u6230\uff09\uff0c\u5728\u6e05\u55ae\u4e0a\u4e5f\u6703\u4ee5\u7d05\u8272\u7684PIV\u6a19\u8a3b\u3002\u82e5\u662f\u5c0d\u55ae\u4e00\u7684\u5c08\u5229\u6709\u8208\u8da3\uff0c\u9ede\u9078\u5c08\u5229\u865f\u5247\u53ef\u4ee5\u986f\u793a\u9019\u4ef6\u5c08\u5229\u7684\u5176\u4ed6\u7d30\u7bc0\uff0c\u5c24\u5176\u662f\u7de8\u8f2f\u5c0d\u65bc\u9019\u4ef6\u5c08\u5229\u7684\u8aaa\u660e\u3002<\/p>\n<p>\u79d1\u777f\u552f\u5b89\u5c08\u5bb6\u7de8\u8f2f\u5718\u968a\u6bcf\u65e5\u8ffd\u8e64 Paragraph IV \u5c08\u5229\u6311\u6230\u7684\u91cd\u8981\u8a0a\u606f\uff0c\u5305\u62ec Mylan \u548c Teva \u5206\u5225\u57282014\u5e74\u548c2016\u5e74\u63d0\u51faANDA\u7533\u8acb\uff0c\u5f15\u767c Bayer \u5f8c\u7e8c\u5c0d Mylan \u548c Teva \u63d0\u544a\uff0c\u4f7f\u5f97 Teva \u7684 ANDA \u66ab\u505c\u5be9\u7406\u81f32019\u5e745\u6708\u3002\u76f8\u8f03\u65bc Teva\uff0c\u5c0d Mylan \u7684\u8a34\u8a1f\u57282017\u5e7410\u6708\u64a4\u92b7\uff0c\u64da\u4fe1 Mylan \u662f\u9996\u5bb6\u6311\u6230\u6210\u529f\u7684\u516c\u53f8\uff0c\u53d6\u5f97180\u5929\u7684\u7368\u5bb6\u92b7\u552e\u6b0a\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\u5c08\u5229\u60c5\u5831\u8490\u96c6\u5fc5\u9808\u5168\u9762\u4e26\u8003\u91cf\u4e0d\u540c\u570b\u5bb6\u7684\u5230\u671f\u65e5\u4ee5\u8a55\u4f30\u81ea\u5bb6\u4e0a\u5e02\u7b56\u7565<\/strong><\/h3>\n<p>\u9664\u7f8e\u570b\u5c08\u5229\u5916\uff0cCortellis \u4e5f\u6536\u9304API\u5728\u5168\u7403\u7684\u5c08\u5229\u5167\u5bb9\uff08\u5305\u62ec\u5c08\u5229\u5bb6\u65cf\u5728\u500b\u5225\u570b\u5bb6\u7684\u5c08\u5229\uff09\uff0c\u9019\u4e9b\u5c08\u5229\u4e0d\u55ae\u6536\u9304\u539f\u958b\u767c\u5ee0\u5546\u7684\u5c08\u5229\u6e05\u55ae\uff0c\u5176\u4ed6\u4f7f\u7528\u76f8\u540cAPI\u7684\u6240\u884d\u751f\u51fa\u7684\u5c08\u5229\u4e5f\u90fd\u6536\u9304\u5728\u5176\u4e2d\u3002\u4ee5 sorafenib \u4f86\u8aaa\uff0c\u5728\u65e5\u672c\u6700\u65e9\u5230\u671f\u7684\u5c08\u5229\u70ba JP4359817 \uff0c\u7576\u9032\u4e00\u6b65\u4e86\u89e3\u9019\u4ef6\u5c08\u5229\u7684\u5167\u5bb9\uff0c\u53ef\u4ee5\u767c\u73fe\u5b83\u4e5f\u662f\u5728\u7f8e\u570b\u7d93\u6b77\u5c08\u5229\u8a34\u8a1f US7351834 \u7684\u5bb6\u65cf\u6210\u54e1\u4e4b\u4e00\uff0c\u5982\u679c\u8981\u751f\u7522\u92b7\u552e sorafenib \u7684\u5b78\u540d\u85e5\uff0c\u9019\u4ef6\u5c08\u5229\u7684\u8a34\u8a1f\u3001\u76f8\u95dc\u6cd5\u5f8b\u72c0\u614b\u6216\u662f\u5426\u6709\u8209\u767c\u7b49\u5176\u4ed6\u5f71\u97ff\u5176\u5c08\u5229\u6709\u6548\u8207\u5426\u7684\u5c08\u5229\uff0c\u5c31\u503c\u5f97\u9032\u4e00\u6b65\u8ffd\u8e64\u548c\u89c0\u5bdf\uff1b\u53e6\u5916 sorafenib \u5316\u5408\u7269\u7684\u5c08\u5229\u5728\u65e5\u672c\u5230\u671f\u6642\u9593\u70ba2023\u5e746\u670819\u65e5\uff0c\u9019\u4e5f\u662f Cortellis \u4f30\u8a08\u5728\u65e5\u672c\u5b78\u540d\u85e5\u53ef\u4e0a\u5e02\u7684\u6642\u9593\u3002\u56e0\u6b64\u4e0d\u55ae\u80fd\u5c0d\u65b0\u85e5\u7684\u5c08\u5229\u6709\u57fa\u790e\u7684\u8abf\u67e5\uff0c\u4e5f\u53ef\u900f\u904e\u5c08\u5229\u5206\u6790\u65e9\u4e00\u6b65\u8fa8\u8b58\u6f5b\u5728\u7684\u5408\u4f5c\u4f19\u4f34\u6216\u5b78\u540d\u85e5\u7684\u7af6\u722d\u5c0d\u624b\u3002<\/p>\n<p>\u5728\u5b78\u540d\u85e5\u5c08\u6848\u8a55\u4f30\u7576\u4e2d\u9664\u4e86\u8981\u8003\u616e\u5c08\u5229\u554f\u984c\uff0c\u5927\u591a\u6578\u7684\u88fd\u5291\u5ee0\u7684API\u591a\u662f\u5916\u8cfc\uff0cAPI\u7684\u4f86\u6e90\u4e5f\u662f\u91cd\u8981\u7684\u6307\u6a19\u3002\u9664\u4e86\u5728\u91cd\u8981\u7684\u5546\u5c55\u5982 CPhI \u548c API\u539f\u6599\u751f\u7522\u5ee0\u5546\u500b\u5225\u6d3d\u8ac7\uff0c\u81ea\u884c\u4e0a\u7db2\u67e5\u8a62DMF\u4e5f\u662f\u5176\u4e2d\u7684\u8a55\u4f30\u65b9\u5f0f\u4e4b\u4e00\u3002 \u79d1\u777f\u552f\u5b89\u7de8\u8f2f\u5718\u968a\u900f\u904e\u8d85\u904e1000\u500b\u7ba1\u9053\u53bb\u8490\u96c6API\u7684\u751f\u7522\u60c5\u6cc1\uff0c\u4e26\u7d66\u4e88\u8a55\u7d1a\uff1b\u4e00\u822c\u800c\u8a00\uff0c\u53ef\u4f9b\u5546\u696d\u4ea4\u6613\u00a0 (commercially available) \u7684\u6a19\u8a3b\u7da0\u8272\u7684\u5713\u5708\uff0c\u82e5\u662f\u9019\u5bb6\u516c\u53f8\u6301\u6709\u6709\u6548\u7684\u7f8e\u570b DMF \uff0c\u5728active US DMF\u9019\u6b04\u5c31\u6703\u6709\u500b\u5c0f\u52fe\u52fe\uff0c\u9664\u4e86US DMF\u5916\uff0c\u4e5f\u53ef\u67e5\u8a62\u6b50\u6d32COS\uff1b\u65e5\u672cDMF\u6216\u97d3\u570bDMF\u7684\u6301\u6709\u60c5\u6cc1\uff0c\u56e0\u6b64\u5c0d\u65bc\u53c3\u8207\u5c08\u6848\u8a55\u4f30\u7684\u4eba\u54e1\u4f86\u8aaa\uff0c\u5c31\u53ef\u4ee5\u5f88\u5bb9\u6613\u638c\u63e1\u53ef\u9032\u4e00\u6b65\u63a5\u6d3d\u7684\u5c0d\u8c61\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>2019.8.21\u66f4\u65b0 \u884c\u653f\u9662\u516c\u544a\u5c08\u5229\u9023\u7d50\u5236\u5ea6\u65bc2019\u5e748\u670820\u65e5\u958b\u59cb\u65bd\u884c\uff0c\u904e\u53bb\u5148\u7533\u8acb\u85e5\u8b49\u5f8c\u518d\u8003\u616e\u662f\u5426\u7b49\u5f85\u5c08\u5229\u5230\u671f\u518d\u4e0a\u5e02\u7684\u4f5c\u6cd5\u4e5f\u9762\u81e8\u6311\u6230\u3002\u5b78\u540d\u85e5\u7522\u54c1\u7dda\u7684\u4f48\u5c40\u4e0d\u518d\u662f\u88ab\u52d5\u7684\u63a5\u6536\u5c08\u5229\u5230\u671f\u7684\u8a0a\u606f\uff0c\u82e5\u662f\u60f3\u63d0\u524d\u9032\u5165\u5e02\u5834\uff0c\u5728\u7522\u54c1\u6216\u7522\u54c1\u7d44\u5408\u898f\u5283\u6642\uff0c\u5c31\u8981\u958b\u59cb\u8003\u616e\u54ea\u4e9b\u5c08\u5229\u6703\u662f\u6211\u7684\u9032\u5165\u969c\u7919\uff1f\u8981\u5982\u4f55\u628a\u76f8\u95dc\u5c08\u5229\u67e5\u5168\uff1f\u7279\u5225\u662f\u6d89\u53ca\u7269\u8cea\u3001\u7d44\u5408\u7269\u6216\u914d\u65b9\u53ca\u91ab\u85e5\u7528\u9014\u7684\u5c08\u5229\u3002\u9664\u4e86\u7b49\u5f85\u539f\u5ee0\u85e5\u767b\u8a18\u7684\u5167\u5bb9\u5916\uff0c\u6709\u6c92\u6709\u5176\u4ed6\u63d0\u524d\u958b\u59cb\u6e96\u5099\u7684\u65b9\u6cd5\uff1f\u5e0c\u671b\u900f\u904e\u4ee5\u4e0b\u7684\u5167\u5bb9\u958b\u555f\u60a8\u53e6\u4e00\u7a2e\u601d\u8def\u3002 &nbsp; \u4f5c\u8005\uff1a\u8d99\u5b87\u8587\uff08\u79d1\u777f\u552f\u5b89 \u751f\u547d\u79d1\u5b78\u89e3\u6c7a\u65b9\u6848\u9867\u554f\uff09 &nbsp; \u5c0d\u8a31\u591a\u5b78\u540d\u85e5\u5ee0\u4f86\u8aaa\uff0c\u5c08\u5229\u4f55\u6642\u5230\u671f\u662f\u63a8\u4f30\u81ea\u5bb6\u7522\u54c1\u4e0a\u5e02\u7533\u8acb\u6642\u7a0b\u7684\u91cd\u8981\u56e0\u7d20\u4e4b\u4e00\u3002\u5c08\u5229\u9023\u7d50\u5236\u5ea6\u53ef\u63d0\u4f9b\u660e\u78ba\u7684\u5c08\u5229\u7d44\u5408\u4f9b\u5b78\u540d\u85e5\u6311\u6230\uff0c\u7136\u800c\u5c0d\u65bc\u5176\u4ed6\u5c1a\u672a\u65bd\u884c\u5c08\u5229\u9023\u7d50\u5236\u5ea6\u7684\u570b\u5bb6\u6216\u5730\u5340\uff08\u5982\u6771\u5357\u4e9e\uff09\uff0c\u539f\u958b\u767c\u5ee0\u7684\u65b0\u85e5\u548c\u5176\u76f8\u5c0d\u61c9\u7684\u5c08\u5229\u7d44\u5408\u5c31\u6c92\u6709\u50cf\u5728\u4f7f\u7528\u5c08\u5229\u9023\u7d50\u5236\u5ea6\u7684\u570b\u5bb6\u90a3\u9ebc\u660e\u78ba\u3002\u5168\u7403\u5b78\u540d\u85e5\u5e02\u5834\u60c5\u5831\u8cc7\u6599\u5eab Cortellis Generics Intelligence \u53ef\u6709\u6548\u5354\u52a9\u5b78\u540d\u85e5\u5ee0\u8de8\u8d8a\u5c08\u5229\u672c\u8eab\u7528\u8a9e\u7684\u7279\u6b8a\u6027\u3001\u5404\u570b\u5c08\u5229\u8aaa\u660e\u66f8\u7684\u8a9e\u8a00\u9694\u95a1\u7b49\u6311\u6230\uff0c\u8b93\u8490\u96c6\u85e5\u54c1\u5c08\u5229\u60c5\u5831\u4efb\u52d9\u66f4\u70ba\u5b8c\u5584\u3002 &nbsp; \u85c9\u7531\u5c08\u5229\u9023\u7d50\u5236\u5ea6\u63d0\u4f9b\u521d\u968e\u7684\u5c08\u5229\u6e05\u55ae \u7f8e\u570b\u57281984\u5e74Hatch-Waxman\u6cd5\u6848\u9812\u5e03\u5f8c\uff0c\u7533\u8acb\u4e0a\u5e02\u7684\u65b0\u85e5\u9700\u8981\u767b\u9304\u76f8\u61c9\u7684\u5c08\u5229\u8cc7\u8a0a\u5305\u62ec\u5c08\u5229\u865f\u3001\u5c08\u5229\u5230\u671f\u65e5\u7b49\u8a0a\u606f\u5728\u6a58\u76ae\u66f8\u4e0a\uff1b\u5728\u5b78\u540d\u85e5\u5ee0\u7533\u8acb\u7c21\u6613\u65b0\u85e5\u4e0a\u5e02\u7533\u8acb (ANDA) \u5f8c\uff0c\u82e5\u662f\u8981\u5728\u5c08\u5229\u4fdd\u8b77\u671f\u5167\u4e0a\u5e02\u7684\u5b78\u540d\u85e5\uff0c\u591a\u6578\u9078\u64c7\u6311\u6230\u65b0\u85e5\u539f\u5ee0\u5c08\u5229\uff0c\u5373 Paragraph IV \u7684\u8def\u5f91\u52a0\u901f\u4e0a\u5e02\uff1b\u7533\u8acb Paragraph IV \u4e0a\u5e02\u7684\u5b78\u540d\u85e5\u5ee0\u5fc5\u9808\u5728FDA\u63a5\u53d7\u7533\u8acb\u5f8c\u768420\u5929\u5167\u901a\u77e5\u539f\u958b\u767c\u85e5\u5ee0\uff0c\u800c\u539f\u958b\u767c\u85e5\u5ee0\u63a5\u7372\u901a\u77e5\u5f8c\u768445\u5929\u5167\u82e5\u63d0\u51fa\u5c08\u5229\u4fb5\u6b0a\u8a34\u8a1f\uff0c\u5247FDA\u5c07\u66ab\u505c\u5be9\u7406\u5b78\u540d\u85e5\u5ee0\u7684ANDA\u7533\u8acb30\u500b\u6708\uff0c\u5f85\u5c08\u5229\u4fb5\u6b0a\u722d\u8b70\u89e3\u6c7a\u621630\u500b\u6708\u5230\u671f\u5f8c\u624d\u7e8c\u884c\u85e5\u8b49\u5be9\u67e5\u7684\u7a0b\u5e8f\uff1b\u7136\u800c\u6b64\u5c08\u5229\u9023\u7d50\u5236\u5ea6\u4e26\u975e\u7368\u539a\u539f\u958b\u767c\u85e5\u5ee0\uff0c\u5c0d\u65bc\u9996\u5bb6\u6311\u6230\u6210\u529f\u7684\u5b78\u540d\u85e5\u5ee0\uff0c\u5247\u662f\u7d66\u8207180\u5929\u7684\u92b7\u552e\u5c08\u5c6c\u6b0a\u5229\uff0c\u4ee5\u9f13\u52f5\u5b78\u540d\u85e5\u63d0\u524d\u4e0a\u5e02\u30022017\u5e74\u5e95\u53f0\u7063\u85e5\u4e8b\u6cd5\u4fee\u6b63\u4e09\u8b80\u901a\u904e\uff0c\u5f15\u5165\u5c08\u5229\u9023\u7d50\u5236\u5ea6\uff0c\u660e\u8a02\u65b0\u85e5\u8a31\u53ef\u8b49\u6301\u6709\u4eba\uff08\u5982\u539f\u958b\u767c\u85e5\u5ee0\u6216\u4ee3\u7406\u5546\uff09\u9700\u63d0\u5831\u7533\u8acb\u8a31\u53ef\u8b49\u85e5\u54c1\u7684\u7269\u8cea\u3001\u7d44\u5408\u7269\u6216\u914d\u65b9\u3001\u91ab\u85e5\u7528\u9014\u7684\u5c08\u5229\uff1b\u7576\u5b78\u540d\u85e5\u7533\u8acb\u4e0a\u5e02\u7d93\u885b\u751f\u4e3b\u7ba1\u6a5f\u95dc\uff08\u5982\u885b\u751f\u798f\u5229\u90e8\u98df\u54c1\u85e5\u7269\u7ba1\u7406\u7f72\uff0cTFDA\uff09\u5c31\u85e5\u54c1\u8a31\u53ef\u8b49\u7533\u8acb\u8cc7\u6599\u9f4a\u5099\u901a\u77e5\u9001\u9054\u6b21\u65e5\u8d7720\u5929\u5167\uff0c\u901a\u77e5\u65b0\u85e5\u8a31\u53ef\u8b49\u6301\u6709\u4eba\uff0c\u82e5\u6b64\u5b78\u540d\u85e5\u4e0a\u5e02\u7533\u8acb\u6709\u5c08\u5229\u4fb5\u6b0a\u7591\u616e\u6642\uff0c\u5c08\u5229\u6b0a\u4eba\u8981\u572845\u5929\u5167\u63d0\u51fa\u8a34\u8a1f\uff0c\u885b\u751f\u4e3b\u7ba1\u6a5f\u95dc\u53ef\u4ee5\u66ab\u505c12\u500b\u6708\u6838\u767c\u8a31\u53ef\u8b49\uff0c\u800c\u5c0d\u65bc\u9996\u5bb6\u5c08\u5229\u6311\u6230\u6216\u8ff4\u907f\u6210\u529f\u7684\u5b78\u540d\u85e5\u5ee0\u5247\u53ef\u7372\u5f9712\u500b\u6708\u7684\u5e02\u5834\u92b7\u552e\u5c08\u5c6c\u671f\u3002 \u5c31\u5168\u7403\u5e02\u5834\u4f86\u770b\uff0c\u5c08\u5229\u9023\u7d50\u5236\u5ea6\u63d0\u4f9b\u660e\u78ba\u7684\u5c08\u5229\u7d44\u5408\u4f9b\u5b78\u540d\u85e5\u6311\u6230\uff0c\u76ee\u524d\u50c5\u6709\u5c11\u6578\u570b\u5bb6\uff0c\u5982\u7f8e\u570b\u3001\u5357\u97d3\u3001\u52a0\u62ff\u5927\u3001\u6fb3\u6d32\u53ca\u5373\u5c07\u65bd\u884c\u5c08\u5229\u9023\u7d50\u5236\u5ea6\u7684\u53f0\u7063\u6709\u76f8\u95dc\u898f\u5b9a\uff1b\u5f9e\u53e6\u4e00\u65b9\u9762\u4f86\u770b\uff0c\u5c0d\u65bc\u5176\u4ed6\u5c1a\u672a\u65bd\u884c\u5c08\u5229\u9023\u7d50\u5236\u5ea6\u7684\u570b\u5bb6\u6216\u5730\u5340\uff0c\u4f8b\u5982\u53f0\u7063\u85e5\u5ee0\u6d89\u8db3\u672a\u6df1\u7684\u6771\u5357\u4e9e\u570b\u5bb6\uff0c\u539f\u958b\u767c\u5ee0\u7684\u65b0\u85e5\u548c\u5176\u76f8\u5c0d\u61c9\u7684\u5c08\u5229\u7d44\u5408\u5c31\u6c92\u6709\u50cf\u5728\u4f7f\u7528\u5c08\u5229\u9023\u7d50\u5236\u5ea6\u7684\u570b\u5bb6\u90a3\u9ebc\u660e\u78ba\u3002\u5c31\u8b58\u5225\u539f\u958b\u767c\u5ee0\u65b0\u85e5\u7684\u5c08\u5229\u6aa2\u7d22\u4f86\u770b\uff0c\u8003\u91cf\u5c08\u5229\u672c\u8eab\u7528\u8a9e\u7684\u7279\u6b8a\u6027\uff0c\u5927\u90e8\u5206\u7684\u60c5\u6cc1\u4e26\u975e\u4ee5\u85e5\u540d\u6216\u85e5\u54c1\u6d3b\u6027\u6210\u5206 (API) \u540d\u7a31\u5c31\u53ef\u4ee5\u76f4\u63a5\u67e5\u8a62\u5230\u76f8\u95dc\u7684\u5c08\u5229\uff1b\u5176\u6b21\u8003\u91cf\u6771\u5357\u4e9e\u570b\u5bb6\u4e26\u975e\u4f7f\u7528\u7d71\u4e00\u8a9e\u8a00\uff0c\u4e14\u5c08\u5229\u8aaa\u660e\u66f8\u662f\u4ee5\u8a72\u570b\u5b98\u65b9\u8a9e\u8a00\u516c\u5e03\uff0c\u4ea6\u589e\u52a0\u5c08\u5229\u8abf\u67e5\u6642\u7684\u96e3\u5ea6\uff1b\u518d\u8005\uff0c\u9664\u8003\u91cf\u539f\u958b\u767c\u85e5\u5ee0\u7684\u5c08\u5229\u5916\uff0c\u5c0d\u65bc\u958b\u767c\u540c\u85e5\u54c1\u7684\u516c\u53f8\u5c08\u5229\u4f48\u5c40\uff0c\u4e5f\u61c9\u56b4\u8b39\u7684\u7d0d\u5165\u5c08\u5229\u8abf\u67e5\u7684\u7bc4\u570d\u3002 \u4ee5\u809d\u764c\u6a19\u9776\u85e5\u7269\u857e\u838e\u74e6(Nexavar\u00ae, \u5176\u4e2d\u85e5\u7269\u6d3b\u6027\u6210\u4efd(API)\u70basorafenib)\u70ba\u4f8b\uff0c\u900f\u904e\u79d1\u777f\u552f\u5b89 \u5168\u7403\u5b78\u540d\u85e5\u5e02\u5834\u60c5\u5831\u8cc7\u6599\u5eab Cortellis Generics&#8230;<\/p>\n","protected":false},"author":2,"featured_media":1183,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_links_to":"","_links_to_type":0,"footnotes":""},"categories":[1668],"tags":[1644,1656,1660,1666],"class_list":["post-1182","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-life-sciences-healthcare","tag-anda","tag-patent-analysis","tag-1660","tag-1666"],"acf":[],"lang":"zh","translations":{"zh":1182},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"pll_sync_post":[],"_links":{"self":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts\/1182","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/comments?post=1182"}],"version-history":[{"count":0,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts\/1182\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/media\/1183"}],"wp:attachment":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/media?parent=1182"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/categories?post=1182"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/tags?post=1182"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}