Lachman CONSULTANTS - Bob Pollock先生
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Four New Paragraph IV Listings Reported
By Bob Pollock | June 22, 2016
OGD published an updated version of its Paragraph IV database (here)This database lists those products that are both first-to-file and have made a paragraph IV certification claiming that at least one patent on the reference listed drug (RLD) upon which its ANDA is based will not be infringed, or that the patent is invalid or unenforceable relative to the product subject of its ANDA filing. These four listings represent potential first filing opportunities for the drugs listed below. The most interesting feature about these products are the dates of submission. The updated FDA list was published on June 21, 2016 with four newly listed products and the ANDA submission dates are very current (April and May 2016). Given the time that FDA has for a filing determination, this data further supports OGD’s position that there is no backlog in the initial completeness and acceptability filing of newly submitted ANDAs.
DRUG NAME
DOSAGE FORM
STRENGTH
RLD
DATE OF SUBMISSION
Adapalene and Benzoyl Peroxide
Gel
0.3%/2.5%
Epiduo Forte
5/4/2016
Avanafil
Tablets
50mg, 100mg and 200mg
Stendra
4/27/2016
Benzyl Alcohol
Lotion
5%
Ulesfia
4/11/2016
Methylphenidate Hydrochloride
Extended-release Chewable Tablets
20mg, 30mg and 40mg
Quillchew ER
4/25/2016
Another interesting tidbit found in my analysis of the list is the demarcation of ANDAs withdrawn or exclusivity relinquished, which are designated by an “*” on the list.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。