FDA加速第IV段ANDA备案
出自识林
FDA加速第IV段ANDA备案
笔记 2015-04-25 Lachman CONSULTANTS 仿制药办公室（OGD）公布了最新的第IV段清单，虽然仅新增了一个产品，但这个产品却应引起人们的注意。新的清单产品是盐酸纳曲酮和盐酸安非他酮缓释片8mg/90mg。这是Contravene的仿制药，用于肥胖和显著超重的减肥药。 我们知道最终所有的新药都会面临仿制药的竞争，但这一产品接近于缓释片的记录，在第IV段数据库中引用的仿制药申请于2015年3月12日备案。这一日期有两点是值得注意的。首先，这表明了OGD真正加速了第IV段ANDA的备案，因为该备案验收审评在ANDA提交后的31天内发生。其次，该ANDA基于的NDA于2014年9月10日获批。从NDA获批到ANDA提交仅6个月的时间。这是一个显著的转变，尤其是对于复杂缓释剂型制剂。 随着从2024年6月到2030年2月一系列7个专利登记，以及3年Hatch-Waxman专营期将于2017年9月10日到期，我们并不指望很快看到这一产品的ANDA获批，但这解释了企业为了获得首个提交的位置的推动力。过去，我们从未见过如此激烈的首个提交状态的竞争。某种程度上可能是由于Mova判决。请记住，FDA对Hatch-Waxman法案关于180天专营期资格的初步解释是，你不仅必须是首个提交，还必须赢得专利挑战。这一立场被所谓的Mova判决推翻。在Mova案例中，法院裁定你只要是首个提交之一；然而你不仅不需要赢得专利挑战以获得180天专营权，你甚至不需要被起诉。（显然有关于180天专营权的其它方面的考虑，但我们不会将那些考虑纳入今天的讨论）。 看来仿制药企业正越来越早的向新的NDA产品发起攻击。请留意这一问题，因为法律问题和任何FDA 30个月停审期在市场竞争中肯定是有吸引力的。 Lachman CONSULTANTS - Bob Pollock先生 2015-04-22 Wow, That Was Quick! The Office of Generic Drugs (OGD) posted its latest paragraph IV listings and, while there was only one new addition to the list, that product caught my attention. The new listing was for Naltrexone Hydrochloride and Bupropion Hydrochloride Extended-Release Tablets 8mg/90mg. It is the generic for Contravene, which is a diet medication for the obese and significantly overweight. Well, we know that, eventually, all new drugs may face generic competition, but this may be close to a record for extended-release tablets, as the generic application referenced in the paragraph IV database was filed on March 12. 2015. This date is notable for two reasons. First, it demonstrates that OGD is really expediting the filing of paragraph IV ANDAs as this filing acceptance review occurred within 31 days of submission of the ANDA. Secondly, the NDA upon which this ANDA is based was approved on September 10, 2014. That is 6 months from approval of the NDA to submission of the ANDA. That is a remarkable turnaround, especially for a complex extended-release dosage formulation. With a series of 7 patents listed that extend from June 2024 to February 2030, and 3-year Hatch-Waxman exclusivity that expires September 10, 2017, we don’t expect to see approval of an ANDA for this product anytime soon, but this illustrates the push that firms will go to in order to gain first-to-file position. In the old days (during my time at FDA), we never saw this much of a race for first-to-file status. This may be in part because of the Mova decision. Remember that FDA’s initial interpretation of the Hatch-Waxman Act relative to qualifying for 180-day exclusivity was that, you not only had to be first-to-file, but you also had to win your patent challenge. That position was overturned by the so-called Mova decision. In that case, the courts ruled all you have to do is be one of the first-to file; however, not only don't you have to win your patent challenge to quality for 180-day exclusivity, you don't even need to be sued! (There are obviously some other considerations relative to 180-day exclusivity but we won’t get into those for today's discussion). It appears that generic manufacturers are pulling the trigger on new NDA products earlier and earlier. Keep your eye on this one, as the legal issues and any FDA 30-month stay will certainly be interesting in the race to market. |