2015年获得美国儿科专营期的药品
出自识林
2015年获得美国儿科专营期的药品
笔记 2016-01-15 Lachman CONSULTANTS 儿科专营期是在专利保护过期后一种广泛的寻求在现有未过期列出专利上添加6个月的专营期（非专利本身，因为只有专利和商标局可以延展一个专利。但在此保护期期间FDA不能批准该药的仿制药）。当儿科专营期被授予，其附加于任何现有未过期市场专营期（3年Hatch-Waxman、5年新化合物和7年孤儿药专营期）；其价值相当可观。试想一个每年30亿美元的药品获得6个月的市场保护，15亿的暴利不可小觑！ FDA更新了其儿科专营期页面（ url）；搜索文档显示2015年9个产品获得儿科专营权。9个产品、公司和适应症如下表所列。 2015年获得儿科专营期的药品
2015年获得儿科专营期的药品数量比2013年或2014年每年6个的数量要高得多。2016年将会发生什么？我们拭目以待，但可以肯定的是企业将一直寻找保护其产品的方式，而儿科专营期无疑是一个好办法。 Lachman CONSULTANTS - Bob Pollock先生 Guess How Many Applications Received Pediatric Exclusivity in 2015? Pediatric exclusivity is a widely sought-after form of patent protection that can add 6 months onto any existing non-expired listed patent protection (not the patent itself, because only the Patent and Trademark Office can extend a patent, but, rather, it is a period of protection during which the FDA cannot approve a generic for the drug). When granted, it attaches to any existing unexpired period market exclusivity (3-year Hatch-Waxman, 5-year new chemical entity and 7-year orphan drug exclusivity); thus its value can be quite considerable. Just think of a $3 billion/year drug product that gets 6 month months of market protection. A $1.5 billion windfall is nothing to sneeze at! The FDA has updated its pediatric exclusivity page ( here); a search of the document reveals 9 different products received pediatric exclusivity during 2015. A look at the products, the firms, and indications are provided in the table below. Pediatric Exclusivity Awarded 2015
The number of awards of pediatric exclusivity in 2015 are substantially higher than the numbers from 2013 or 2014, when 6 awards were made in each of those years. What will 2016 bring? We will see, but it is certain that the industry will be looking to protect their products, and pediatric exclusivity is certainly a good way to do that! |