{"id":68326,"date":"2024-05-15T11:10:00","date_gmt":"2024-05-15T03:10:00","guid":{"rendered":"https:\/\/naipnews.naipo.com\/?p=68326"},"modified":"2026-07-15T11:32:20","modified_gmt":"2026-07-15T03:32:20","slug":"%e8%a2%aa%e7%97%b0%e8%8d%af%e7%89%a9%e4%b9%8b%e5%9d%87%e7%ad%89%e4%be%b5%e6%9d%83%ef%bc%9aadams-respiratory-therapeutics-inc-v-perrigo-co-%ef%bc%88fed-cir-2010%ef%bc%89","status":"publish","type":"post","link":"https:\/\/naipnews.naipo.com\/zh-hans\/68326\/","title":{"rendered":"\u88aa\u75f0\u836f\u7269\u4e4b\u5747\u7b49\u4fb5\u6743\uff1aAdams Respiratory Therapeutics, Inc. v. Perrigo Co.\uff08Fed. Cir. 2010\uff09"},"content":{"rendered":"<figure id=\"attachment_2323\" aria-describedby=\"caption-attachment-2323\" style=\"width: 1024px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-2323\" src=\"https:\/\/naipnews.naipo.com\/wp-content\/uploads\/2025\/01\/C1-2.jpg\" alt=\"\" width=\"1024\" height=\"683\" srcset=\"https:\/\/naipnews.naipo.com\/wp-content\/uploads\/2025\/01\/C1-2.jpg 1024w, https:\/\/naipnews.naipo.com\/wp-content\/uploads\/2025\/01\/C1-2-768x512.jpg 768w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><figcaption id=\"caption-attachment-2323\" class=\"wp-caption-text\">\u56fe\u7247\u6765\u6e90 : shutterstock\u3001\u8fbe\u5fd7\u5f71\u50cf<\/figcaption><\/figure>\n<blockquote><p>\u5f53\u6211\u4eec\u7531\u5916\u754c\u5438\u5165\u7a7a\u6c14\u4e4b\u540e\uff0c\u547c\u5438\u9053\u4e2d\u7684\u9ecf\u6db2\u4f1a\u5c06\u4e00\u4e9b\u5916\u6765\u5f02\u7269\u5305\u8986\uff0c\u5f62\u6210\u75f0\u6db2\u3002\u5065\u5eb7\u7684\u4e2a\u4f53\uff0c\u4e0d\u4f1a\u4ea7\u751f\u592a\u591a\u7684\u75f0\u6db2\uff0c\u56e0\u6b64\uff0c\u591a\u534a\u65e0\u987b\u501f\u52a9\u5916\u529b\uff0c\u5373\u53ef\u81ea\u884c\u5c06\u75f0\u6db2\u54b3\u51fa\u3002\u7136\u800c\uff0c\u4e25\u91cd\u611f\u67d3\u75c7\u6216\u957f\u671f\u53d1\u708e\u7684\u60a3\u8005\uff0c\u75f0\u6db2\u7684\u91cf\u4f1a\u53d8\u591a\u4e14\u6d53\u7a20\uff0c\u8f83\u4e0d\u6613\u81ea\u884c\u5c06\u75f0\u6db2\u54b3\u51fa\u4f53\u5916\uff0c\u56e0\u6b64\uff0c\u4e9f\u9700\u501f\u52a9\u88aa\u75f0\u836f\u7269\u7684\u4f7f\u7528\uff0c\u8f85\u52a9\u60a3\u8005\u987a\u5229\u5c06\u75f0\u6db2\u6392\u51fa\u4f53\u5916\uff0c\u4ee5\u4fdd\u6301\u547c\u5438\u9053\u7545\u901a\u3002Adams\u836f\u5382\u4e3a\u88aa\u75f0\u836f\u7269Mucinex\u00ae\u4e4b\u4e13\u5229\u6743\u4eba\uff0c\u5176\u8ba4\u4e3a\u57f9\u745e\u514b\u5b66\u540d\u836f\u5382\u7533\u8bf7\u8be5\u88aa\u75f0\u836f\u7269\u4e4b\u5b66\u540d\u836f\u7b80\u6613\u65b0\u836f\u4e0a\u5e02\u7a0b\u5e8f\uff0c\u4fb5\u5bb3\u5176\u4e13\u5229\u6743\u3002\u56e0\u6b64\uff0cAdams\u836f\u5382\u4ee5\u539f\u544a\u8eab\u5206\u5411\u8054\u90a6\u5730\u65b9\u6cd5\u9662\u63d0\u8d77\u4e86\u8be5\u88aa\u75f0\u836f\u7269\u4e4b\u4fb5\u6743\u8bc9\u8bbc\uff0c\u4e8e\u672c\u4ef6\u8bc9\u8bbc\u4e2d\uff0c\u7a76\u7adf\u662f\u88ab\u544a\u57f9\u745e\u514b\u5b66\u540d\u836f\u5382\u4fb5\u5bb3\u8be5\u88aa\u75f0\u836f\u7269\u4e4b\u4e13\u5229\u6743\uff0c\u8fd8\u662f\u80fd\u6210\u529f\u6297\u8fa9\u800c\u88ab\u6cd5\u9662\u8ba4\u5b9a\u672a\u4fb5\u6743\uff1f\u7ed3\u679c\u5982\u4f55\uff0c\u8ba9\u672c\u6587\u85c9\u7531Adams Respiratory Therapeutics, Inc. v. Perrigo Co.\uff08Fed. Cir. 2010\uff09<a class=\"Article_content_15px\" href=\"https:\/\/naipnews.naipo.com\/zh-hans\/68326#1\">[1]<\/a>\u6848\u4ef6\uff0c\u6765\u7814\u7a76\u88aa\u75f0\u836f\u7269\u7684\u5747\u7b49\u4fb5\u6743\u95ee\u9898\u3002<\/p><\/blockquote>\n<p class=\"Article_tittle_3_blue_bold\" style=\"font-size: 36px;\"><span style=\"color: #026292;\">\u6848\u4ef6\u80cc\u666f<\/span><\/p>\n<p>\u672c\u6848\u88ab\u544a\u57f9\u745e\u514b\u5b66\u540d\u836f\u5382 (Perrigo Co.) \u56e0\u4e3a\u5411\u7f8e\u56fd\u98df\u54c1\u836f\u7269\u7ba1\u7406\u5c40 (FDA) \u63d0\u51fa\u4e86\u88aa\u75f0\u836f\u7269Mucinex\u00ae (\u6210\u5206\u4e3a\u6108\u75ae\u7518\u6cb9\u919a\uff0cguaifenesin) \u7684\u5b66\u540d\u836f\u8bb8\u53ef\u4e4b\u7b80\u6613\u65b0\u836f\u4e0a\u5e02\u7a0b\u5e8f (ANDA) \u3002\u539f\u544aAdams\u836f\u5382(Adams Respiratory Therapeutics, Inc.) \u4e8e\u662f\u5411\u7f8e\u56fd\u5bc6\u6267\u5b89\u5dde\u897f\u533a (the Western District of Michigan) \u7684\u8054\u90a6\u5730\u65b9\u6cd5\u9662\u63d0\u51fa\u4e13\u5229\u4fb5\u6743\u8bc9\u8bbc\uff0c\u4e3b\u5f20\u88ab\u544a\u57f9\u745e\u514b\u5b66\u540d\u836f\u5382\u4fb5\u5bb3\u7cfb\u4e89\u4e13\u5229\uff0c\u7136\u800c\uff0c\u5730\u65b9\u6cd5\u9662\u7ecf\u8fc7\u5224\u51b3\u540e\u8ba4\u5b9a\u88ab\u544a\u57f9\u745e\u514b\u5b66\u540d\u836f\u5382\u672a\u4fb5\u5bb3\u7cfb\u4e89\u4e13\u5229\u3002\u539f\u544aAdams\u836f\u5382\u4e0d\u670d\u5730\u65b9\u6cd5\u9662\u7684\u5224\u51b3\uff0c\u6240\u4ee5\u63d0\u51fa\u4e0a\u8bc9\u3002<\/p>\n<p class=\"Article_tittle_3_blue_bold\" style=\"font-size: 36px;\"><span style=\"color: #026292;\">\u88aa\u75f0\u836f\u7269\u7b80\u4ecb<\/span><\/p>\n<p>\u4eba\u4f53\u7684\u4e0b\u547c\u5438\u9053\u9ecf\u819c\u6709\u7740\u9ecf\u6db2\u53ca\u7ea4\u6bdb\uff0c\u5f53\u6211\u4eec\u7531\u5916\u754c\u5438\u5165\u7a7a\u6c14\u4e4b\u540e\uff0c\u547c\u5438\u9053\u4e2d\u7684\u9ecf\u6db2\u4f1a\u5c06\u4e00\u4e9b\u5916\u6765\u5f02\u7269\u5305\u8986\uff0c\u5f62\u6210\u75f0\u6db2\u3002\u5065\u5eb7\u7684\u4e2a\u4f53\uff0c\u4e0d\u4f1a\u4ea7\u751f\u592a\u591a\u7684\u75f0\u6db2\uff0c\u56e0\u6b64\uff0c\u591a\u534a\u65e0\u987b\u501f\u52a9\u5916\u529b\uff0c\u5373\u53ef\u81ea\u884c\u5c06\u75f0\u6db2\u54b3\u51fa\u3002\u7136\u800c\uff0c\u4e25\u91cd\u611f\u67d3\u75c7\u6216\u957f\u671f\u53d1\u708e\u7684\u60a3\u8005\uff0c\u75f0\u6db2\u7684\u91cf\u4f1a\u53d8\u591a\u4e14\u6d53\u7a20\uff0c\u8f83\u4e0d\u6613\u81ea\u884c\u5c06\u75f0\u6db2\u54b3\u51fa\u4f53\u5916\u3002\u56e0\u6b64\uff0c\u4e9f\u9700\u501f\u52a9\u88aa\u75f0\u836f\u7269\u7684\u4f7f\u7528\uff0c\u8f85\u52a9\u60a3\u8005\u987a\u5229\u5c06\u75f0\u6db2\u6392\u51fa\u4f53\u5916\uff0c\u4ee5\u4fdd\u6301\u547c\u5438\u9053\u7545\u901a<a class=\"Article_content_15px\" href=\"https:\/\/naipnews.naipo.com\/zh-hans\/68326#1\">[2]<\/a>\u3002<\/p>\n<p>\u4e34\u5e8a\u4e0a\u5e38\u89c1\u7684\u795b\u75f0\u836f\u7269\u6709\u56db\u79cd\u7c7b\uff0c\u75f0\u6db2\u6db2\u5316\u5242\uff08expectorants\uff09\u3001\u5316\u75f0\u5242\uff08mucolytics\uff09\u3001\u9ecf\u6db2\u8c03\u8282\u5242\uff08mucoregulatory agents\uff09\u3001\u53ca\u4fc3\u8fdb\u75f0\u6db2\u6e05\u9664\u5242\uff08mucokinetic agents\uff09\u3002\u4e0e\u672c\u6587\u6709\u5173\u4e4b\u6108\u75ae\u7518\u6cb9\u919a\uff0c\u5c5e\u4e8e\u7b2c\u4e00\u7c7b\u7684\u75f0\u6db2\u6db2\u5316\u5242\uff0c\u5176\u53ef\u4ee5\u5e2e\u52a9\u547c\u5438\u9053\u4e4b\u5206\u6ccc\u6db2\u589e\u52a0\uff0c\u4f7f\u75f0\u6db2\u4e0e\u6c34\u5206\u7ed3\u5408\u540e\uff0c\u964d\u4f4e\u75f0\u6db2\u7684\u9ecf\u6027\uff0c\u4e14\u8ba9\u75f0\u6db2\u7684\u6d41\u52a8\u6027\u4e0a\u5347\uff0c\u60a3\u8005\u80fd\u591f\u8f83\u5bb9\u6613\u5730\u5c06\u75f0\u6db2\u6392\u51fa\u4f53\u5916<a class=\"Article_content_15px\" href=\"https:\/\/naipnews.naipo.com\/zh-hans\/68326#1\">[3]<\/a>\u3002<\/p>\n<p class=\"Article_tittle_3_blue_bold\" style=\"font-size: 36px;\"><span style=\"color: #026292;\">\u672c\u6848\u7cfb\u4e89\u4e13\u5229\u53ca\u751f\u4f53\u53ef\u7528\u7387\u4e4b\u5b9a\u4e49<\/span><\/p>\n<p>\u672c\u6848\u7cfb\u4e89\u4e13\u5229\u4e3a\u7f8e\u56fd\u4e13\u5229\u7b2c6,372,252\u53f7(&#8216;252\u4e13\u5229)<a class=\"Article_content_15px\" href=\"https:\/\/naipnews.naipo.com\/zh-hans\/68326#1\">[4]<\/a>\uff0c\u6b64\u4e13\u5229\u7684\u4e13\u5229\u6743\u4eba\u4e3aAdams\u836f\u5382\u3002\u7cfb\u4e89\u4e13\u5229\u4e4b\u7533\u8bf7\u4e13\u5229\u8303\u56f4\u603b\u5171\u670956\u9879\uff0c\u5176\u4e2d\uff0c\u7533\u8bf7\u4e13\u5229\u8303\u56f4\u7b2c24\u9879\u4e0e\u672c\u6848\u6700\u4e3a\u76f8\u5173\uff0c\u5217\u51fa\u5982\u4e0b\uff1a<\/p>\n<ol start=\"24\">\n<li>A modified release product having two portions, wherein a first portion comprises a first quantity of guaifenesin in an immediate release form which becomes fully bioavailable in the subject&#8217;s stomach and a second portion comprises a second quantity of guaifenesin in a sustained release form wherein the ratio of said first quantity to said second quantity provides a C.sub.max in a human subject equivalent to the C.sub.max obtained when the first of three doses of a standard immediate release formulation having one third the amount of guaifenesin is dosed every four hours over a 12 hour period and wherein said product also provides therapeutically effective bioavailability for at least twelve hours after a single dose in a human subject according to serum analysis.<\/li>\n<\/ol>\n<p>\u7533\u8bf7\u4e13\u5229\u8303\u56f4\u7b2c24\u9879\u4e4b\u4e2d\u6587\u7ffb\u8bd1\u5982\u4e0b\uff1a<\/p>\n<ol start=\"24\">\n<li>\u4e00\u79cd\u5177\u4e24\u90e8\u5206\u4e4b\u8c03\u63a7\u91ca\u653e\u4ea7\u54c1 (modified release product) \uff0c\u5176\u4e2d\uff0c\u7b2c\u4e00\u90e8\u5206\u5305\u542b\u4e00\u7b2c\u4e00\u91cf\u7acb\u5373\u91ca\u653e\u578b\u4e4b\u6108\u75ae\u7518\u6cb9\u919a\u4e8e\u76ee\u6807\u4e4b\u80c3\u90e8\u5177\u5b8c\u6574\u7684\u751f\u4f53\u53ef\u7528\u6027 (bioavailable) \uff1b\u7b2c\u4e8c\u90e8\u5206\u5305\u542b\u4e00\u7b2c\u4e8c\u91cf\u6301\u7eed\u91ca\u653e\u578b\u4e4b\u6108\u75ae\u7518\u6cb9\u919a\uff0c\u5176\u4e2d\uff0c\u8be5\u7b2c\u4e00\u91cf\u4e0e\u8be5\u7b2c\u4e8c\u91cf\u7684\u6bd4\u503c\u63d0\u4f9b\u60a3\u8005\u4e4b\u6700\u9ad8\u8840\u4e2d\u6d53\u5ea6\u4e0e\u7ed9\u4e88\u4e09\u5242\u6807\u51c6\u7acb\u5373\u91ca\u653e\u7ec4\u6210\u7684\u7b2c\u4e00\u5242\u800c\u83b7\u5f97\u4e4b\u4e09\u5206\u4e4b\u4e00\u91cf\u6108\u75ae\u7518\u6cb9\u919a\u7684\u6700\u9ad8\u8840\u4e2d\u6d53\u5ea6\u76f8\u7b49 (equivalent)\uff0c\u8be5\u6108\u75ae\u7518\u6cb9\u919a\u4e3a12 \u5c0f\u65f6\u4e2d\u6bcf4 \u5c0f\u65f6\u7ed9\u4e88\uff1b\u4ee5\u53ca\uff0c\u5176\u4e2d\uff0c\u4f9d\u64bd\u8840\u6e05\u5206\u6790\u8be5\u4ea7\u54c1\u4e5f\u63d0\u4f9b\u4e8e\u4eba\u4f53\u4e2d\u7ed9\u4e88\u5355\u4e00\u5242\u91cf\u540e\u81f3\u5c1112\u5c0f\u65f6\u4e4b\u6cbb\u7597\u6548\u679c\u7684\u751f\u4f53\u53ef\u7528\u7387 (bioavailability)\u3002<\/li>\n<\/ol>\n<p>\u5176\u4e2d\uff0c\u7533\u8bf7\u4e13\u5229\u8303\u56f4\u7b2c24\u9879\u6240\u79f0\u4e4b\u300c\u751f\u4f53\u53ef\u7528\u7387\u300d\uff0c\u6307\u836f\u54c1\u6709\u6548\u6210\u5206\u7531\u5236\u5242\u4e2d\u5438\u6536\u8fdb\u5165\u5168\u8eab\u8840\u6db2\u5faa\u73af\u6216\u4f5c\u7528\u90e8\u4f4d\u4e4b\u901f\u7387\uff08rate\uff09\u4e0e\u7a0b\u5ea6\uff08extent\uff09\u4e4b\u6307\u6807\u3002\u5982\u7cfb\u4e0d\u5177\u5168\u8eab\u6027\u5438\u6536\u4e4b\u836f\u54c1\uff0c\u5219\u6307\u4ee5\u6709\u6548\u6210\u5206\u5230\u8fbe\u4f5c\u7528\u90e8\u4f4d\u4e4b\u901f\u7387\u4e0e\u7a0b\u5ea6\u4f5c\u8bc4\u4f30\u4e4b\u6307\u6807\u3002<\/p>\n<p class=\"Article_tittle_3_blue_bold\" style=\"font-size: 36px;\"><span style=\"color: #026292;\">\u672c\u6848\u5224\u51b3<\/span><\/p>\n<p style=\"font-size: 28px;\"><span style=\"color: #026292;\">\u25cf\u00a0<strong>\u89e3\u91ca\u7533\u8bf7\u4e13\u5229\u8303\u56f4<\/strong><\/span><\/p>\n<p>\u89e3\u91ca\u7533\u8bf7\u4e13\u5229\u8303\u56f4\u4e4b\u76ee\u7684\u5728\u4e8e\u6b63\u786e\u89e3\u91ca\u7533\u8bf7\u4e13\u5229\u8303\u56f4\u4e4b\u6587\u5b57\u610f\u4e49\uff0c\u4ee5\u786e\u8ba4\u7533\u8bf7\u4e13\u5229\u8303\u56f4\u6240\u754c\u5b9a\u4e4b\u8303\u56f4\u3002\u539f\u544aAdams\u836f\u5382\u4e0e\u88ab\u544a\u57f9\u745e\u514b\u5b66\u540d\u836f\u5382\u5bf9\u4e8e\u7533\u8bf7\u4e13\u5229\u8303\u56f4\u4e2d\u300c\u76f8\u7b49(equivalent)\u300d\u4e00\u8bcd\u6709\u6240\u4e89\u8bae\uff0c\u5730\u65b9\u6cd5\u9662\u5bf9\u4e8e\u300c\u76f8\u7b49\u300d\u4e00\u8bcd\u4f5c\u51fa\u89e3\u91ca\uff0c\u8ba4\u4e3a\u5176\u7cfb\u572890%\u4fe1\u8d56\u533a\u95f4\u4e0b\uff0c\u6700\u9ad8\u8840\u4e2d\u6d53\u5ea6\u4e4b\u6570\u503c\u572880%\u81f3125%\u4e4b\u95f4\u3002\u5730\u65b9\u6cd5\u9662\u4e4b\u8be5\u89e3\u91ca\u7cfb\u57fa\u4e8e\u539f\u544aAdams\u836f\u5382\u4e8e\u518d\u5ba1\u67e5\u65f6\uff0c\u4f9dFDA \u751f\u4f53\u76f8\u7b49\u6027\u51c6\u5219\u6240\u63d0\u51fa\u4e4b\u7b54\u8fa9\u3002<\/p>\n<p>\u4e0a\u8bc9\u65f6\uff0c\u4e0a\u8bc9\u4ebaAdams\u836f\u5382\u5bf9\u4e8e\u5730\u65b9\u6cd5\u9662\u8ba4\u5b9a\u987b\u300c\u572890%\u4fe1\u8d56\u533a\u95f4\u4e0b\u300d\u63d0\u51fa\u4e89\u8bae\uff0c\u5176\u4e3b\u5f20\u7cfb\u4e89\u4e13\u5229\u4e4b\u8bf4\u660e\u4e66\u5185\u65e0\u9700\u4e14\u4e5f\u65e0\u63d0\u53ca\u4efb\u4f55\u4fe1\u8d56\u533a\u95f4\uff0cAdams\u836f\u5382\u6307\u51fa\u5176\u4e8e\u518d\u5ba1\u67e5\u65f6\u53ea\u63d0\u53ca\u6700\u9ad8\u8840\u4e2d\u6d53\u5ea6\u4e4b\u6570\u503c\u572880%\u81f3125%\u4e4b\u95f4\uff0c\u800c\u65e0\u987b\u9644\u52a0\u4efb\u4f5590%\u4fe1\u8d56\u533a\u95f4\u4e4b\u9650\u5236\u3002\u4e0a\u8bc9\u6cd5\u9662\u5219\u540c\u610f\u4e0a\u8bc9\u4ebaAdams\u836f\u5382\u4e4b\u4e3b\u5f20\uff0c\u8ba4\u4e3a\u300c\u76f8\u7b49\u300d\u4e4b\u89e3\u91ca\uff0c\u4ec5\u987b\u6700\u9ad8\u8840\u4e2d\u6d53\u5ea6\u572880%\u81f3125%\u4e4b\u95f4\uff0c\u5e76\u65e090%\u4fe1\u8d56\u533a\u4e4b\u9650\u5236\u3002<\/p>\n<p style=\"font-size: 28px;\"><span style=\"color: #026292;\">\u25cf\u00a0<strong>\u6bd4\u5bf9\u88ab\u63a7\u4fb5\u6743\u7269\uff0c\u4e8e\u4e00\u5b9a\u6761\u4ef6\u4e0b\u5f97\u4ee5\u95f4\u63a5\u6bd4\u8f83\u7684\u65b9\u5f0f\u4e3a\u4e4b<\/strong><\/span><\/p>\n<p>\u4e3a\u4e86\u8bc1\u660e\u300c\u76f8\u7b49\u300d\uff0c\u5373\u88ab\u544a\u57f9\u745e\u514b\u5b66\u540d\u836f\u5382\u4e4b\u88ab\u63a7\u4fb5\u6743\u7269\u5177\u6709\u4e0e\u7acb\u5373\u91ca\u653e\u4e4b\u6807\u51c6\u54c1\u76f8\u7b49\u7684\u6700\u9ad8\u8840\u4e2d\u6d53\u5ea6\uff0c\u539f\u544aAdams\u836f\u5382\u63d0\u51fa\u8bc1\u636e\u8bc1\u660e\u88ab\u63a7\u4fb5\u6743\u7269\u4e0e\u5176\u5546\u54c1Mucinex\u00ae\u5177\u751f\u4f53\u76f8\u7b49\u6027\uff0c\u53c8\u5176\u5546\u54c1Mucinex\u00ae \u4e0e\u7acb\u5373\u91ca\u653e\u4e4b\u6807\u51c6\u54c1\u5177\u751f\u4f53\u76f8\u7b49\u6027\u3002\u60df\u5730\u65b9\u6cd5\u9662\u4e0d\u5141\u8bb8 (impermissible) \u6b64\u79cd\u300c\u95f4\u63a5\u6bd4\u8f83\u300d\u7684\u65b9\u5f0f\uff0c\u5e76\u6307\u51fa\u53ea\u6709\u5c06\u88ab\u63a7\u4fb5\u6743\u7269\u76f4\u63a5\u6bd4\u8f83\u7533\u8bf7\u4e13\u5229\u8303\u56f4\u65b9\u624d\u6070\u5f53\uff0c\u4e14\u539f\u544aAdams\u836f\u5382\u5982\u679c\u8981\u91c7\u7528\u8fd9\u6837\u6bd4\u8f83\u65b9\u5f0f\uff0c\u5fc5\u987b\u5148\u5efa\u7acb\u63a7\u4fb5\u6743\u7269\u4e0e\u7acb\u5373\u91ca\u653e\u4e4b\u6807\u51c6\u54c1\u4e4b\u53cc\u5411\u4ea4\u53c9\u8bd5\u9a8c\uff08two-way crossover study\uff09\u3002\u56e0\u6b64\uff0c\u5730\u65b9\u6cd5\u9662\u8ba4\u4e3a\u539f\u544aAdams\u836f\u5382\u672a\u80fd\u987a\u5229\u8bc1\u660e\u6709\u6587\u4e49\u4fb5\u6743\u53ca\u5747\u7b49\u4fb5\u6743\u4e4b\u4e89\u8bae\u3002<\/p>\n<p>\u4e0a\u8bc9\u65f6\uff0cAdams\u836f\u5382\u4e89\u8bae\u65e0\u987b\u6267\u884c\u8be5\u53cc\u5411\u4ea4\u53c9\u8bd5\u9a8c\uff0c\u4e14\u5b9e\u9645\u4e4b\u6700\u9ad8\u8840\u4e2d\u6d53\u5ea6\u6570\u503c\u5df2\u63d0\u4f9b\u8db3\u591f\u4e4b\u4fb5\u6743\u8bc1\u636e\u3002\u4e0a\u8bc9\u6cd5\u9662\u540c\u610f\u4e0a\u8bc9\u4ebaAdams\u836f\u5382\u4e4b\u4e3b\u5f20\uff0c\u5176\u8ba4\u4e3a\u5e76\u672a\u7981\u6b62\u88ab\u63a7\u4fb5\u6743\u7269\u4e0e\u5546\u4e1a\u5b9e\u65bd\u4f8b (\u6b64\u5904\u6307\u7acb\u5373\u91ca\u653e\u4e4b\u6807\u51c6\u54c1) \u4e92\u76f8\u6bd4\u8f83\uff0c\u88ab\u63a7\u4fb5\u6743\u7269\u5fc5\u987b\u7b26\u5408\u7533\u8bf7\u4e13\u5229\u8303\u56f4\u4e2d\u7684\u6240\u6709\u9650\u5236\uff0c\u4e14\u5f53\u5546\u4e1a\u5b9e\u65bd\u4f8b\u4ea6\u7b26\u5408\u7533\u8bf7\u4e13\u5229\u8303\u56f4\u4e2d\u7684\u6240\u6709\u9650\u5236\u65f6\uff0c\u6bd4\u8f83\u8be5\u5546\u4e1a\u5b9e\u65bd\u4f8b\u7cfb\u8db3\u4ee5\u652f\u6301\u4fb5\u6743\u7684\u8ba4\u5b9a\u3002\u56e0\u6b64\uff0c\u4e0a\u8bc9\u6cd5\u9662\u8ba4\u4e3a\uff0c\u6bd4\u5bf9\u88ab\u63a7\u4fb5\u6743\u7269\uff0c\u4e8e\u4e00\u5b9a\u6761\u4ef6\u4e0b\u5f97\u4ee5\u95f4\u63a5\u6bd4\u8f83\u7684\u65b9\u5f0f\u4e3a\u4e4b\uff0c\u6545\u4e0a\u8bc9\u4ebaAdams\u836f\u5382\u5df2\u8bc1\u660e\u672c\u6848\u4ecd\u5b58\u6709\u4fb5\u6743\u4e4b\u4e89\u8bae\u3002<\/p>\n<p style=\"font-size: 28px;\"><span style=\"color: #026292;\">\u25cf\u00a0<strong>\u672c\u6848\u662f\u5426\u65e0\u5747\u7b49\u4fb5\u6743\uff0c\u5c1a\u5b58\u6709\u7591\u4e49<\/strong><\/span><\/p>\n<p>\u7531\u4e8e\u4e13\u5229\u6743\u8303\u56f4\u7cfb\u4ee5\u8bf7\u6c42\u9879\u4e3a\u51c6\uff0c\u60df\u6b32\u4e8e\u8bf7\u6c42\u9879\u4ee5\u6587\u5b57\u7cbe\u786e\u3001\u5b8c\u6574\u63cf\u8ff0\u7533\u8bf7\u4e13\u5229\u4e4b\u53d1\u660e\uff0c\u6709\u5176\u5148\u5929\u4e0a\u65e0\u6cd5\u514b\u670d\u4e4b\u56f0\u96be\uff0c\u56e0\u6b64\uff0c\u4e3a\u5f25\u8865\u8bf7\u6c42\u9879\u7684\u8bed\u8a00\u5c40\u9650\u6027\uff0c\u4e13\u5229\u6743\u8303\u56f4\u975e\u4ec5\u9650\u4e8e\u8bf7\u6c42\u9879\u754c\u5b9a\u4e4b\u8303\u56f4\uff0c\u800c\u5f97\u9002\u5ea6\u6269\u5927\u81f3\u4e0e\u8bf7\u6c42\u9879\u754c\u5b9a\u4e4b\u8303\u56f4\u4e3a\u5747\u7b49\u7684\u8303\u56f4(\u300c\u5747\u7b49\u8303\u56f4\u300d\uff0c\u6216\u5747\u7b49\u8bba)<a class=\"Article_content_15px\" href=\"https:\/\/naipnews.naipo.com\/zh-hans\/68326#1\">[5]<\/a>\uff0c\u5f53\u88ab\u63a7\u4fb5\u6743\u7269\u843d\u5165\u5747\u7b49\u8303\u56f4\u65f6\uff0c\u5219\u79f0\u5747\u7b49\u4fb5\u6743\u3002<\/p>\n<p>\u4e0a\u8bc9\u65f6\uff0c\u4e0a\u8bc9\u4ebaAdams\u836f\u5382\u4e3b\u5f20\u7cfb\u4e89\u4e13\u5229\u4e4b\u7533\u8bf7\u4e13\u5229\u8303\u56f4\u5177\u6709\u5747\u7b49\u8303\u56f4\uff0c\u53ef\u6db5\u76d6\u81f3\u88ab\u4e0a\u8bc9\u4eba\u57f9\u745e\u514b\u5b66\u540d\u836f\u5382\u4e4b\u88ab\u63a7\u4fb5\u6743\u7269\u3002\u88ab\u4e0a\u8bc9\u4eba\u57f9\u745e\u514b\u5b66\u540d\u836f\u5382\u5219\u4ee5\u7cfb\u4e89\u4e13\u5229\u4e4b\u7533\u8bf7\u4e13\u5229\u8303\u56f4\u672a\u4f7f\u7528\u5177\u8fd1\u4f3c\u542b\u610f\u4e4b\u6587\u5b57\uff0c\u56e0\u6b64\uff0c\u65e0\u6cd5\u4ee5\u5747\u7b49\u8303\u56f4\u6db5\u76d6\u88ab\u63a7\u4fb5\u6743\u7269\u3002\u4e0a\u8bc9\u6cd5\u9662\u5219\u8ba4\u4e3a\u7cfb\u4e89\u4e13\u5229\u4e4b\u7533\u8bf7\u4e13\u5229\u8303\u56f4\u4e2d\uff0c\u5e76\u672a\u4f7f\u7528\u5177\u8fd1\u4f3c\u542b\u610f\u4e4b\u6587\u5b57\u4e0d\u5f71\u54cd\u4fb5\u6743\u5206\u6790\uff0c\u8be5\u6587\u5b57\u4ec5\u5728\u6587\u4e49\u4fb5\u6743\u4e4b\u6269\u5f20\u65f6\u6709\u9002\u7528\uff0c\u800c\u4e0d\u9002\u7528\u4e8e\u5747\u7b49\u8303\u56f4\u4e2d\u3002\u672c\u6848\u771f\u6b63\u7684\u95ee\u9898\u5e94\u4e3a\u88ab\u63a7\u4fb5\u6743\u4e4b\u6700\u9ad8\u8840\u4e2d\u6d53\u5ea6\u6570\u503c\u662f\u5426\u4e0e\u7cfb\u4e89\u4e13\u5229\u4e4b\u7533\u8bf7\u4e13\u5229\u8303\u56f4\u4e4b\u6700\u9ad8\u8840\u4e2d\u6d53\u5ea6\u6570\u503c\u65e0\u5b9e\u8d28\u4e0a\u5dee\u5f02\uff0c\u4e8e\u6b64\u90e8\u5206\u56e0\u5c1a\u5b58\u6709\u7591\u4e49\uff0c\u56e0\u6b64\uff0c\u4e0a\u8bc9\u6cd5\u9662\u64a4\u9500\u5730\u65b9\u6cd5\u9662\u4e0d\u4fb5\u5bb3\u7cfb\u4e89\u4e13\u5229\u7533\u8bf7\u4e13\u5229\u8303\u56f4\u4e4b\u5747\u7b49\u8303\u56f4\u7684\u8ba4\u5b9a\u3002<\/p>\n<p class=\"Article_tittle_3_blue_bold\" style=\"font-size: 36px;\"><span style=\"color: #026292;\">\u603b\u7ed3<\/span><\/p>\n<p>\u867d\u7136\uff0c\u672c\u6848\u88ab\u4e0a\u8bc9\u4eba\u57f9\u745e\u514b\u5b66\u540d\u836f\u5382\u662f\u5426\u672a\u4fb5\u5bb3\u7cfb\u4e89\u4e13\u5229\u7533\u8bf7\u4e13\u5229\u8303\u56f4\u4e4b\u5747\u7b49\u8303\u56f4\uff0c\u5c1a\u5b58\u6709\u7591\u4e49\u3002\u7136\u800c\uff0c\u672c\u6848\u4e4b\u91cd\u8981\u6027\u5728\u4e8e\uff0c\u85c9\u7531\u672c\u6848\u63d0\u4f9b\u4e86\u4e13\u5229\u6743\u4eba\u4e8e\u4e00\u5b9a\u6761\u4ef6\u4e0b\uff0c\u53ef\u91c7\u7528\u95f4\u63a5\u6bd4\u8f83\u7684\u65b9\u5f0f\u6bd4\u5bf9\u88ab\u63a7\u4fb5\u6743\u7269\u3002<\/p>\n<p>\u4e00\u822c\u800c\u8a00\uff0c\u5728\u68c0\u89c6\u88ab\u63a7\u4fb5\u6743\u7269\u662f\u5426\u6784\u6210\u4fb5\u6743\u65f6\uff0c\u4f1a\u4ee5\u7cfb\u4e89\u4e13\u5229\u4e4b\u7533\u8bf7\u4e13\u5229\u8303\u56f4\u4e4b\u5404\u8981\u4ef6\u53bb\u6bd4\u5bf9\u88ab\u63a7\u4fb5\u6743\u7269\uff0c\u6b64\u4e3a\u76f4\u63a5\u6bd4\u8f83(\u6bd4\u5bf9)\u3002\u60df\u6b64\u6848\u4e2d\uff0c\u4e0a\u8bc9\u6cd5\u9662\u8ba4\u4e3a\u300c\u6bd4\u5bf9\u88ab\u63a7\u4fb5\u6743\u7269\uff0c\u4e8e\u4e00\u5b9a\u6761\u4ef6\u4e0b\u5f97\u4ee5\u95f4\u63a5\u6bd4\u8f83\u7684\u65b9\u5f0f\u4e3a\u4e4b\u300d\u3002\u4e0a\u8bc9\u4ebaAdams\u836f\u5382\u4e8e\u88ab\u63a7\u4fb5\u6743\u7269\u53ca\u7acb\u5373\u91ca\u653e\u4e4b\u6807\u51c6\u54c1\u7686\u7b26\u5408\u7533\u8bf7\u4e13\u5229\u8303\u56f4\u4e2d\u7684\u6240\u6709\u9650\u5236\u65f6(\u6b64\u4e3a\u4e00\u5b9a\u6761\u4ef6\u4e0b)\uff0c\u5f97\u4ee5\u88ab\u63a7\u4fb5\u6743\u7269\u4e0e\u5176\u5546\u54c1Mucinex\u00ae\u5177\u751f\u4f53\u76f8\u7b49\u6027\uff0c\u53c8\u5176\u5546\u54c1Mucinex\u00ae \u4e0e\u7acb\u5373\u91ca\u653e\u4e4b\u6807\u51c6\u54c1\u5177\u751f\u4f53\u76f8\u7b49\u6027\u4e4b\u95f4\u63a5\u6bd4\u8f83\u65b9\u5f0f\u6765\u6bd4\u5bf9\u88ab\u63a7\u4fb5\u6743\u7269 (\u6b64\u4e3a\u95f4\u63a5\u6bd4\u8f83\u7684\u65b9\u5f0f\uff0c\u4e5f\u5c31\u662f\u5f53A\u7b49\u4e8eB\uff0c\u4e14B\u7b49\u4e8eC\u65f6\uff0c\u5219\u6b64\u65f6A\u4f1a\u7b49\u4e8eC)\u3002<\/p>\n<p><a id=\"1\" name=\"1\"><\/a>\u5907\u6ce8\uff1a<\/p>\n<div>\n<ol>\n<li class=\"Article_footer_note\">Adams Respiratory Therapeutics, Inc. v. Perrigo Co.,616 F.3d 1283\uff08Fed. Cir. 2010\uff09<\/li>\n<li class=\"Article_footer_note\">\u8d22\u56e2\u6cd5\u4eba\u5168\u6c11\u5065\u5eb7\u57fa\u91d1\u4f1a\uff0c\u5982\u4f55\u6b63\u786e\u4f7f\u7528\u795b\u75f0\u836f\uff1f\u7f51\u5740\uff1a<a href=\"https:\/\/www.depression.org.tw\/knowledge\/info.asp?\/68.html\" target=\"_blank\" rel=\"noopener\">https:\/\/www.depression.org.tw\/knowledge\/info.asp?\/68.html<\/a> (\u6700\u540e\u6d4f\u89c8\u65e5\uff1a2024\u5e744\u67089\u65e5)<\/li>\n<li class=\"Article_footer_note\">\u540c\u524d\u6ce8\u3002<\/li>\n<li class=\"Article_footer_note\">US 6372252<\/li>\n<li class=\"Article_footer_note\">\u667a\u6167\u8d22\u4ea7\u5c40\uff0c\u4fb5\u5bb3\u9274\u5b9a\u8981\u70b9\uff0c\u987539\uff0c2016\u5e74\u3002<\/li>\n<\/ol>\n<\/div>\n<table class=\"Yellowtable01\" border=\"0\" width=\"100%\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td bgcolor=\"#FFFFDF\">\n<table border=\"0\" width=\"100%\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td bgcolor=\"#FFFFDF\">\n<p class=\"Article_tittle_3_blue_bold\" style=\"font-size: 28px;\" align=\"center\"><span style=\"color: #026292;\"><strong>\u597d\u6d88\u606f\uff5e\u5317\u7f8e\u667a\u6743\u62a5\u6709\u5fae\u4fe1\u516c\u4f17\u53f7\u4e86\uff01<\/strong><\/span><\/p>\n<p>\u300a\u5317\u7f8e\u667a\u6743\u62a5\u300b\u5185\u5bb9\u6db5\u76d6\u4e16\u754c\u5404\u56fd\u7684\u77e5\u8bc6\u4ea7\u6743\u65b0\u95fb\u3001\u91cd\u8981\u7684\u4fb5\u6743\u8bc9\u8bbc\u6848\u4f8b\u5206\u6790\u3001\u6cd5\u89c4\u89e3\u6790\uff0c\u4ee5\u53ca\u4ea7\u4e1a\u4e0e\u6280\u672f\u65b0\u77e5\u7b49\u7b49\u3002<\/p>\n<p align=\"center\"><strong>\u7acb\u5373\u5173\u6ce8\u5317\u7f8e\u667a\u6743\u5fae\u4fe1\u516c\u4f17\u53f7\u2192 NAIP_IPServices<\/strong><\/p>\n<p align=\"center\">\uff5e\u6b22\u8fce\u8bfb\u8005\u5206\u4eab\u4e0e\u8f6c\u53d1\uff5e<\/p>\n<\/td>\n<td bgcolor=\"#FFFFDF\"><span class=\"Article_tittle_2_blue_bold\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter size-full wp-image-37159\" src=\"https:\/\/naipnews.naipo.com\/wp-content\/uploads\/2025\/12\/NAIPNews_wechat.jpg\" alt=\"\" width=\"251\" height=\"252\" \/><\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<p class=\"Article_content_15px\"><strong>\u3010\u672c\u6587\u53ea\u53cd\u6620\u4e13\u5bb6\u4f5c\u8005\u610f\u89c1\uff0c\u4e0d\u4ee3\u8868\u672c\u62a5\u7acb\u573a\u3002\u3011<\/strong><\/p>\n<table border=\"0\" width=\"94%\" cellspacing=\"1\" cellpadding=\"8\">\n<tbody>\n<tr>\n<td bgcolor=\"#EFEFF8\">\n<table border=\"0\" width=\"100%\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td valign=\"top\" width=\"157\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter size-full wp-image-2331\" src=\"https:\/\/naipnews.naipo.com\/wp-content\/uploads\/2025\/01\/C5-1.jpg\" alt=\"\" width=\"162\" height=\"207\" \/><\/td>\n<td width=\"25\"><\/td>\n<td valign=\"top\" width=\"479\">\n<table border=\"0\" width=\"100%\" cellspacing=\"0\" cellpadding=\"3\">\n<tbody>\n<tr>\n<td class=\"Article_content_15px\" valign=\"top\" bgcolor=\"#DBDBEE\" width=\"13%\"><strong>\u4f5c\u8005\uff1a<\/strong><\/td>\n<td class=\"Article_content_15px\" valign=\"top\" bgcolor=\"#DBDBEE\" width=\"87%\"><strong>\u90ed\u5ef7\u6fe0<\/strong><\/td>\n<\/tr>\n<tr>\n<td class=\"Article_content_15px\" valign=\"top\"><strong>\u73b0\u4efb\uff1a<\/strong><\/td>\n<td class=\"Article_content_15px\" valign=\"top\">\u8d85\u8d8a\u6cd5\u5f8b\u4e8b\u52a1\u6240\u4e3b\u6301\u5f8b\u5e08<\/td>\n<\/tr>\n<tr>\n<td class=\"Article_content_15px\" valign=\"top\" bgcolor=\"#DBDBEE\"><strong>\u5b66\u5386\uff1a<\/strong><\/td>\n<td class=\"Article_content_15px\" valign=\"top\" bgcolor=\"#DBDBEE\">\u53f0\u5927\u836f\u7406\u6240\u7855\u58eb<br \/>\n\u53f0\u79d1\u5927\u4e13\u5229\u6240\u7855\u58eb<\/td>\n<\/tr>\n<tr>\n<td class=\"Article_content_15px\" valign=\"top\" bgcolor=\"#EFEFF8\"><strong>\u4e13\u957f\uff1a<\/strong><\/td>\n<td class=\"Article_content_15px\" valign=\"top\" bgcolor=\"#EFEFF8\">1. \u6c11\u4e8b\u3001\u5211\u4e8b\u3001\u884c\u653f\u3001\u533b\u7597\u8bc9\u8bbc<br \/>\n2. \u836f\u4e8b\u3001\u4e13\u5229\u6cd5\u89c4<br \/>\n3. \u751f\u6280\u3001\u533b\u836f\u4e13\u5229<br \/>\n4. \u836f\u7269\u836f\u7406\u5b66<\/td>\n<\/tr>\n<tr>\n<td class=\"Article_content_15px\" valign=\"top\" bgcolor=\"#DBDBEE\"><strong>\u8bc1\u7167\uff1a<\/strong><\/td>\n<td class=\"Article_content_15px\" valign=\"top\" bgcolor=\"#DBDBEE\">109\u5e74\u5ea6\u4e2d\u534e\u6c11\u56fd\u4e13\u5229\u5e08\u8003\u8bd5\u53ca\u683c<br \/>\n112\u5e74\u5ea6\u4e2d\u534e\u6c11\u56fd\u5f8b\u5e08\u8003\u8bd5\u53ca\u683c<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>Adams\u836f\u5382\u4e3a\u88aa\u75f0\u836f\u7269Mucinex\u00ae\u4e4b\u4e13\u5229\u6743\u4eba\uff0c\u5176\u8ba4\u4e3a\u57f9\u745e\u514b\u5b66\u540d\u836f\u5382\u7533\u8bf7\u8be5\u88aa\u75f0\u836f\u7269\u4e4b\u5b66\u540d\u836f\u7b80\u6613\u65b0\u836f\u4e0a\u5e02\u7a0b\u5e8f\uff0c\u4fb5\u5bb3\u5176\u4e13\u5229\u6743\u3002\u672c\u6587\u85c9\u7531Adams Respiratory Therapeutics, Inc. v. Perrigo Co.\uff08Fed. Cir. 2010\uff09\u6848\u4ef6\uff0c\u6765\u7814\u7a76\u88aa\u75f0\u836f\u7269\u7684\u5747\u7b49\u4fb5\u6743\u95ee\u9898\u3002<\/p>\n","protected":false},"author":10,"featured_media":1761,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[254,285,277,256],"tags":[],"author_name1":[330],"class_list":{"0":"post-68326","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-254","8":"category-285","9":"category-277","10":"category-256","11":"author_name1--zh-hans"},"_links":{"self":[{"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/posts\/68326","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/users\/10"}],"replies":[{"embeddable":true,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/comments?post=68326"}],"version-history":[{"count":1,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/posts\/68326\/revisions"}],"predecessor-version":[{"id":68328,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/posts\/68326\/revisions\/68328"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/media\/1761"}],"wp:attachment":[{"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/media?parent=68326"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/categories?post=68326"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/tags?post=68326"},{"taxonomy":"author_name1","embeddable":true,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/author_name1?post=68326"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}