1、1.http:/www.accessdata.fda.gov/scripts/cder/drugsatfda/输入所要找的药物名称(商品名,有效成分名都可以)比如找 LIPITOR ,就直接输入药名,点击 SubMit进一步点击链接后可看到:LIPITOR(NDA # 020702)信息。记下:Application Number:0207022.登陆http:/www.fda.gov/cder/ob/default.htm选择:Search by Application Number进入http:/www.fda.gov/cder/ob/docs/queryno.htm输入:020702得到
2、详细信息,然后再选择其中的一个链接进去,就能看到详细信息了。点击 Patent and Exclusivity Info for this product: Click Here大功告成:http:/www.accessdata.fda.gov/scripts/cder/ob/docs/patexcl.cfm?Appl_No=020702&Product_No=001&table1=RxFDA 专利相关术语:INGREDIENT NAME -成分名TRADE NAME -商标名PATENT EXPIRES -专利过期时间USE CODE -用途代码EXCLUS CODE -独占权代码EXCLU
3、S EXPIRES -独占权过期时间PED -儿科用药独占权Orange Book橙皮书收录 FDA 批准的所有处方药物,包括新药及不注册药品。每月更新。The Electronic Orange Book Query enables searching of the approved drug list by active ingredient, proprietary name, applicant holder or applicant number. The data is updated concurrently with the publication of the annual
4、edition or cumulative supplements.电子版橙皮书;可以通过药物活性成分、专利名等多种角度查询 FDA 批准的药物,与文本版及增补部分同时更新。Orange Book Annual EditionThe publication identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act文本版橙皮书:据此识别 FD
5、A 依据联邦食品、药物、化学品法案,按照安全及有效的原则批准的药物产品。Orange Book Current Cumulative SupplementThe monthly Cumulative Supplement publication provides information on newly approved drugs, changes and revisions to current data including therapeutic equivalence evaluations, and updated patent and exclusivity data.橙皮书累积增
6、补本;提供新近批准的药物信息,对当前数据包括治疗等价评价、最新专利及专有数据的更新及修正。橙皮书每月还提供修改本,将对文本版橙皮书的修改(增加及删除)按月份列出。Electronic Orange Book 检索功能实探Search by Active IngredientSearch by Applicant HolderSearch by Proprietary NameSearch by Application NumberSearch by Patent5 类检索功能大同小异,分别按活性成分,申请人,专利商品名,申请号,专利号进行检索,进入检索界面后,填入相关对应的名称,同时在下面:Rx (Prescription Drug Products) 处方药OTC (Over-the-Counter Drug Products) 非处方药Disc (Discontinued Drug Products) 停用药物中选择相关的分类点击 SubMit 进行检索。