OGD Approves 108 First Time Approvals in CY 2019

OGD reported the approval of 108 first time generic approvals in CY 2019.  This is the highest total in at least 4 years, with previous totals of 99 for 2018, 80 for 2017, and 73 for 2016.  There are many reasons for variations in the number of first approvals, some of which relate to the number of products that may be eligible for approval after a period of New Chemical Entity exclusivity, or patent expiration for a paragraph III drug patent settlements, or a number of other factors.  It is also interesting to note that OGD counts multiple first approvals for the same product approved on the same day which may (depending on the circumstances) skew the view of the actual total counts.  For instance, there were 4 sets of 2 applications approved for a specific unique product, 2 sets of 3, 2 sets of 4, 1 set of 5, 1 set of 8, and 1 set of 10 applications approved for a specific unique product approved on the same day.

In addition, the higher number of first-time generic approvals may be due to OGD prioritizing certain applications for drug products for which there is no competition or paragraph IV challenge drugs.  Nonetheless, the trend over the last 4 years is still impressive.  The full list of first-time generic approvals can be found here.  Good job, OGD!