FY2020 GDUFA ANDA Holder Fees Just Announced...
Remain A Significant Expense Item For Unused ANDAs
We offer relief to ANDA Holders, especially small and medium firms, through a PROVEN GDUFA II Program Fee approach
The ANDA Holder Program fee schedule for Fiscal Year 2020 was published by FDA on July 6 2019, and the fees remain a significant expense item for many firms. Fees are now as follows:
Small 1-5 $166,168
Medium 6-19 $664,674
Large 20 or more $1,661,684
Firms with a modest number of ANDAs will again be paying substantial fees for unused ANDAs for products they may not even currently market or are identiﬁed as Discontinued in the Orange Book. For a small- or medium-tier company this can be a dramatic hurdle simply to retain the assets they worked so hard to own.
Discontinued ANDAs are still considered approved ANDAs for user fee purposes unless the approval is withdrawn. And once withdrawn, ANDAs become virtually impossible to reactivate. Your asset may be gone forever. Further, no one yet knows what will happen to the ANDAs identiﬁed as “not marketed” from last year’s one-time marketing status report as submitted to the FDA.
A PROVEN Solution
Well into its third year of operations, ANDA Repository, LLC. offers signiﬁcant user-fee relief and a solution for companies with discontinued ANDAs or drug products not currently marketed. Like with a parking lot, car owners need space for their cars, whether in use or not. At ANDA Repository, in exchange for the space to park (and a fee), car owners transfers title of the cars to the parking lot owner. The former car owners can, with appropriate notice, resume ownership when they choose to use the car again. Since the parking lot owner has enough cars, this venture beneﬁts for all the parties involved, and the cars remain safe and secure.
In the example above, the car owner is an ANDA owner, and the parking lot owner is ANDA Repository, LLC which charges ANDA owners an annual fee signiﬁcantly less than the GDUFA II ANDA Holder Program Fee the FDA charges small- or medium-sized ﬁrms. There is NO need to pay excessive fees or be forced to with-draw your valued assets due to short-term market conditions, capacity constraints, API supplier issues, etc.
And check with us before WITHDRAWING your ANDAs…
we may be interested in purchasing them!
The FY2020 GDUFA Generic Drug Applicant Program Fee is due October 1st, 2019, so please act now!
For more info contact us:
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