FDA Para IV 清单更新四个产品
|
首页 > 资讯 > FDA Para IV 清单更新四个产品 出自识林
FDA Para IV 清单更新四个产品
笔记 2016-06-26 Lachman CONSULTANTS 6月21日仿制药办公室（OGD）更新了第IV段声明数据库（Paragraph IV数据库，PIVDB）pdf
在我对清单的分析中另一个趣闻是对ANDA撤销或专营权放弃的区分，在清单上由“*”标明。目前清单上共有40这样的标志（一些是针对具体规格，其它是针对整个产品）。其中最近的日期是在2012年，一些可以追溯到2004年清单首次建立的时候。ANDA的撤销可能引发专营权的丧失或公司可能放弃其专营权，从而另外的ANDA申请人可以获得批准。专营权的放弃是罕见事件，当申请人对其ANDA提交存在困难时，通常该申请人与另一申请人达成协议获得一些偿付来放弃其专营权。这是一个相当冒险的举动，如果阻碍批准的唯一问题是潜在的首个提交者的180天专营权，一旦放弃专营权，任何可批准的ANDA都能获得最终批准。 Lachman CONSULTANTS - Bob Pollock先生 Four New Paragraph IV Listings Reported OGD published an updated version of its Paragraph IV database (here
Another interesting tidbit found in my analysis of the list is the demarcation of ANDAs withdrawn or exclusivity relinquished, which are designated by an “*” on the list. There are 40 such designations (some for specific strengths, others for the entire product) found on the current list. The most recent date of these was in 2012, with some stretching back to 2004 when the list was first started. Remember that the withdrawal of an ANDA can trigger loss of exclusivity or a firm may relinquish its exclusivity so that another ANDA applicant can be approved. Relinquishment of exclusivity is a rare event, and in the past, has occurred when one applicant was having difficulty with its ANDA submission, and they made a deal with another applicant, typically, with some payment for them to relinquish their rights to exclusivity. This is a rather risky move, since once exclusivity is relinquished, any otherwise approvable ANDA can obtain final approval, if the only thing blocking approval was the potential first filers 180-day exclusivity. Funny the things you can pick up when you look a little more closely at something! |
。该数据库列出了首次提交并取得第IV段声明的产品，即ANDA所根据的参照产品的至少一个专利在其ANDA递交中不被侵犯或无效或无法执行。这一数据库旨在为预期的ANDA申请人提供专利保护品种的第一份ANDA何时提交给仿制药办公室的信息。下面列出的四个药品代表了潜在的首次提交机会。这些产品最有意思的地方在于提交日期。这份更新的清单于6月21日公布，这四个新列出产品的ANDA提交日期都非常近（2016年4月和5月）。考虑到FDA做出备案决定需要时间，这一数据进一步支持了新提交的ANDA在OGD初始完整性和可接受性备案方面没有积压的立场。