The GDUFA fees for FY 2021 we announced today on the Federal Register pre-publication page (here). The new fees will be applicable for all submissions submitted on or after October 1, 2020. The FY 2021 fees with a comparison to the FY 2020 fees appear in the table below.

GDUFA FY 2021 Fee Schedule

Fee Category Rates for FY 2021 Rates for FY 2020 Percent Change (approx.)
Applications
   ANDAs $196,868 $176,237 +11.7%
   DMFs $69,921 $57,795 +20.9%
Facilities
   API Domestic $41,671 $44,400 -6.2%
   API Foreign $56,671 $59,400 -6.2%
   Finished Dosage Form (FDF) Domestic $184,022 $195,662 -6%
   FDF Foreign $199,022 $210,662 -6%
Contract Mfg. Organization Domestic $61,341 $65,221 -6%
Contract Mfg. Organization Foreign $76,341 $80,221 -6%
GDUFA Program
   Large Size Generic Firm >20 ANDAs $1,542,993 $1,661,684 -7.2%
   Med. Size Generic Firm 6-19 ANDAs $617,197 $664,674 -7.2%
   Small Generic Firm 5 or less ANDAs $154,299 $166,168 -7.2%

 

As you can see, the only fees that increased this year related to the application fee (ANDAs and DMFs) were due to the lower projection of applications, as FDA projected 867 ANDAs to be submitted in FY 2021 and expected some of the ANDAs to be refused for filing but resubmitted in the same FY.  Thus, the total number of fee-paying applications is actually projected at 872, substantially lower than the 1044 submitted in 2018 and the 909 submitted in 2019.  In reaching that number, FDA also factored in ANDAs submitted through April 2020 of this FY (536).  We have projected 884 ANDA to be submitted in FY 2020 based on the rate of monthly submission through June 2020.  The same is true of the DMFs, where FDA is projecting a lower number of fee-paying DMFs.

As far as facility and program fees, it is assumed that the number of facilities has increased, as well as the number of players in the categories for the program fees.  We have seen a number of new firm’s names in the approval listing throughout the year.  So, thank the interest in generic drugs for lowering the rest of the associated GDUFA fees for FY 2021.

So, happy GDUFA II year 3 fees, everyone.  Talk to your comptrollers and get them set with the new numbers!