It is interesting that the FDA provides reports of first generic approvals by calendar year, but activity by fiscal year.  Today we will look at the last 5 calendar years of first approvals and try to make some assumptions of what these numbers reflect in the scheme of generic approvals in general. The chart below provides a look at the first generic approvals for the time frame identified above.

Calendar Year No. of First Approvals
2013 106
2014 97
2015 90
2016 73
2017 74


There are many factors that contribute to the totals for each of the calendar years:

  • If there were multiple ANDAs approved on the same day, they are counted separately, so the figures represent totals for all first approvals and not individual specific entities.
  • Obviously, the number of patent expiration dates of reference listed products or periods of exclusivity expiration impact potential first approvals.
  • Expiration of 30-month stays could impact first generic approvals; one must remember that because an ANDA is approved, because of outstanding or ongoing patent litigation, the product may or may not be marketed.
  • First generic approvals are those “(1) That is a first-to-file ANDA eligible for 180-day exclusivity, or for which there are no blocking patents or exclusivities; and (2) for which there is no previously-approved ANDA for the drug product.”

If we just look at the numbers, one could mistakenly conclude that the downward trend in first generic approvals over the last 5 years is somehow bad.  However, we know that the number of overall ANDA approvals have reached record highs, so any conclusions drawn must consider the impact of the bullets listed above.  We also know that we hit the patent cliff after 2015, thus fewer first time generic approvals could occur. Having navigated the cliff, there may be more products eligible for first generic approval status coming in the next few years.

OGD is giving priority for first-to-file opportunities and expediting ANDAs where there is no current competition.  This too should improve the FDA’s ability to get first generics to market faster.  The data on first generic approvals can be found here, which is a link to the 2017 data. You can get to previous years from the ANDA (Generic) Drug Approvals – Previous Years link on the upper left side of the webpage.  There is also an archived section for 2001-2015 data that can be found at that link.  While this information is indeed interesting, take care in its interpretation – it may obscure the real facts.