Question marks. Idea or problem concept. 3d

How Do You Explain the Large Surge in ANDAs in March?

In the “you learn something new every day” category, I got schooled by my good friend Lisa Parks from AAM this morning.  After she read a quote from me pleading ignorance as to why there were so many ANDAs submitted in March, she cleared it up.  It appears that March is the end of India’s year, so their March is our December!  And just like in the US, folks scramble to get things in by accounting year’s end!

To verify this theory, I went back to the last 5 yearly Activities Report of The Generic Drug Program and here is what I found:

FY Dec ANDAs (rank) March ANDAs (rank) Monthly Avg
2013 163 (1st) 86 (4th) 80.7
2014 225 (2nd) 112 (4th) 122.75*
2015 43 (6th) 57 (3rd) 44.9**
2016 180 (1st) 114 (2nd) 71
2017 235 (1st) 197 (2nd) 122.7***

* This was the year of the stability change, and we saw 635 ANDA submitted in June.

** This was a year of reloading for everyone after the previous June rush, so the pipeline was still empty in December.

*** These figures are through March 2017.

Per these results, there does appear to be a trend for higher submissions in March.  This was an interesting exercise and I hope that this gives you a new way to look at the numbers for March as we march towards GDUFA II.