First-Time Generic Approvals in FY 2014 and 2015

In December 2014, we did a story on First-Time generic approvals for FY 2013 (here). In that post we noted that, for FY 2013, the Office of Generic Drugs (OGD) reported approving 108 first time generic products.  This information was taken from OGD’s Generic Approval reports (here) and navigating to 2013’s First-Time list (here). Because it has been a while since we looked at First-Time generic approvals, and since OGD has now begun to expedite the review of First-Time generic products (in certain circumstances), we thought we would take another look at the numbers for FY 2014 and 2015 and the first 7 months of FY 2016.

The table below outlines FDA’s reports of first generic approvals for the respective time periods.

*- FY 2016 through April 2016

While these numbers are interesting, I am not certain how much we can say about them other than they speak for themselves.  Should we conclude that, because in 2015 only 71 first time approvals were made,  OGD had a slow down?  No, not at all.  There are obviously a number of factors outside of OGD’s control, such as patent and exclusivity protection, including 5-year NCE exclusivity, 3-year Hatch-Waxman exclusivity and 180-day generic exclusivity, not to mention pediatric exclusivity extensions and patent delays.  In addition, the changing number of products that may be first time eligible for generic approval and a host of other issues like application quality, the complexity of the product or the API also impact OGD’s ability to get First-Time generics to market.   However, this chart does demonstrate that OGD does focus on brining First-Time generic drugs to market as fast as they can.

In the future, if the ANDA approval process picks up enough speed and as the GDUFA goal dates hit 10 months (as they will in FY 2017), we may be able to make more of a comparison of the number of ANDA receipts and vs the % of First-Time generic approvals.  But, even then, trying to make assumptions based on just those two metrics may prove to be shortsighted as the full story cannot be gleaned from that limited data.  The hope would be that the numbers of first generic approvals will be consistent with the limitations for approval and reflect an effort by OGD to assure that, if an ANDA can be approved as a first generic, it is approved at the first date that it can be legally approved.