FDA Sets Generic Drug User Fees for Fiscal Year 2027
Published Date: 7/30/2026
Notice
Summary
The Federal Food, Drug, and Cosmetic Act (FD&C Act or statute), as amended by the Generic Drug User Fee Amendments of 2022 (GDUFA III), authorizes the Food and Drug Administration (FDA, Agency, or we) to assess and collect fees for abbreviated new drug applications (ANDAs); drug master files (DMFs); generic drug active pharmaceutical ingredient (API) facilities, finished dosage form (FDF) facilities, and contract manufacturing organization (CMO) facilities; and generic drug applicant program user fees. In this document, FDA is announcing fiscal year (FY) 2027 rates for GDUFA III fees.
Analyzed Economic Effects
6 provisions identified: 0 benefits, 6 costs, 0 mixed.
FY2027 GDUFA Fee Schedule Set
The FDA set the FY2027 Generic Drug User Fee rates that take effect October 1, 2026 through September 30, 2027. Key line items include an ANDA fee of $375,684, a DMF fee of $109,899, domestic API facility fee of $39,680, domestic FDF facility fee of $230,033, and a large applicant program fee of $1,927,291.
ANDA Filing Fee Requirement
Each applicant that submits an Abbreviated New Drug Application (ANDA) on or after October 1, 2026 must pay a filing fee of $375,684 due on the ANDA submission date. If an ANDA is refused-to-receive (RTR) for reasons other than failure to pay fees or is withdrawn prior to receipt, 75 percent of the ANDA fee is refundable under the rule.
Facility Annual Fees and $15K Foreign Differential
Owners of facilities identified in at least one approved generic drug submission owe annual facility fees in FY2027: domestic API $39,680 and foreign API $54,680; domestic FDF $230,033 and foreign FDF $245,033; domestic CMO $55,208 and foreign CMO $70,208. The foreign fee is $15,000 higher than the corresponding domestic fee.
Tiered Applicant Program Fees by ANDA Count
Generic drug applicant program fees for FY2027 are tiered based on approved ANDA ownership as of October 1, 2026: small (1–5 approved ANDAs) pay $192,729, medium (6–19) pay $770,916, and large (20 or more) pay $1,927,291. FDA estimated there will be 196 small-tier, 67 medium-tier, and 78 large-tier applicants for FY2027.
DMF One-Time Fee for Referenced Files
Owners of Type II API Drug Master Files (DMFs) that are first referenced in an ANDA or that request the initial completeness assessment on or after October 1, 2026 owe a one-time DMF fee of $109,899. FDA estimated 303 fee-paying DMFs for FY2027 and uses that denominator to set the $109,899 fee.
Operating Reserve Reduced FY2027 Revenue
FDA applied an operating reserve adjustment of -$36,160,352 because estimated FY2026 carryover equaled 14.68 weeks of operations, exceeding the 12-week threshold. After inflation and adjustments, the total FY2027 revenue amount used to set fees is $665,986,000 (rounded).
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