The FDA released its FY 2020 quarterly report of the Generics Drug Program late yesterday.  By the numbers, mean approval times reported by quarterly cohort have not changed significantly from quarter to quarter, and are driven by the age of the applications ready for and approved in that quarter.

The Generics program has approved more tentatively approved ANDA than the industry has been able to turn into full approvals over this FY.  It is likely that patent and/or exclusivity expirations has a role in this figure’s increase.  ANDAs awaiting FDA action appear relatively constant on a quarter by quarter basis while the number of ANDAs awaiting industry action appears to be dropping.  This could be based on the number of pending unapproved ANDAs withdrawn (153 reported through August 2020).  There is clearly a steady state of ANDAs pending with FDA and those ANDAs awaiting response from industry.

First Quarter
October – December
Second Quarter
January – March
Third Quarter
April – June
Fourth quarter
July – September
ANDAs awaiting FDA Action 1752 1656 1752 1702
ANDAs awaiting Applicant TA 449 452 461 476
ANDAs awaiting Applicant Action 1755 1831 1685 1668
Mean AP Approval Time – Action Cohort 28.15 32.37 31.47 33.48
Median AP Approval Time – Action Cohort 20.70 25.58 20.44 20.24
Mean TA Approval Time – Action Cohort 26.55 27.40 37.22 33.35
Median TA Approval Time – Action Cohort 20.25 24.15 28.62 25.02

The mean and median approval times for tentatively approved applications are both good news and  bad news for industry, as it appears that approval times still may play a part in potential forfeiture of 180-day exclusivity especially in the last two quarters, while the median approval times may paint a better picture, since all of the median TA approval times are under 30 months.  Again, knowing the median means half below and half above – that picture may not be as rosy as it seems.

It is difficult to take away too much from these numbers as there are so many factors in play from quarter to quarter and the numbers are impacted by the application’s age in the quarterly cohorts.  How about you in industry – are you happy?  Let us know.