Generic Drug User Fee Amendments

•February 13, 2026

FDA – U.S. Food & Drug Administration (RSS Feeds)•Feb 13, 2026

Why It Matters

GDUFA III secures predictable FDA funding, accelerating generic‑drug reviews and preserving affordable patient access, while the heightened fees increase compliance costs for manufacturers.

Key Takeaways

•FY2025 ANDA fee rises to $321,920.
•Large program fee exceeds $1.9 million per company.
•Foreign facilities pay $15,000 premium over domestic.
•Non‑payment triggers arrears list and submission bans.
•Fees due October 1; penalties start after 20 days.

Pulse Analysis

The Generic Drug User Fee Amendments, first enacted in 2012, were designed to give the FDA a stable financial base for reviewing abbreviated new drug applications (ANDAs). By re‑authorizing GDUFA through 2027, Congress reaffirmed its commitment to a transparent, predictable fee structure that supports the agency’s mission of delivering safe, high‑quality, and affordable generics. GDUFA III builds on earlier iterations, incorporating stakeholder feedback and expanding fee categories to cover both applicant programs and manufacturing facilities.

Under GDUFA III, FY 2025 and FY 2026 fee schedules reflect a modest but notable increase across the board. The ANDA filing fee climbs to $321,920, while program fees for large, medium, and small portfolios range from $189,166 to $1,891,664. Facility fees differentiate domestic and foreign sites, adding a $15,000 surcharge for overseas inspections. These adjustments aim to offset rising inspection costs and to fund performance goals such as reduced review times. For manufacturers, the new rates translate into higher annual operating expenses, prompting strategic portfolio reviews and potential consolidation to stay within lower fee tiers.

Compliance risk has also intensified. Missing the October 1 deadline triggers a 20‑day grace period after which applicants face arrears listings, bans on new ANDA submissions, and the misbranding of existing products. Such penalties can disrupt supply chains and erode market share, especially for smaller firms. Looking ahead, industry observers anticipate GDUFA IV discussions for FY 2028‑2032, where fee structures may further evolve in response to inflation and FDA resource needs. Companies that proactively manage fee obligations and align their filing strategies with GDUFA’s performance metrics will be better positioned to maintain market access and capitalize on the growing generic drug landscape.

Generic Drug User Fee Amendments

On September 30 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022, which includes the re‑authorization of the Generic Drug User Fee Amendments (GDUFA) through September 2027 (GDUFA III). Congress first enacted GDUFA in 2012, following negotiations between the FDA and industry and with input from public stakeholders. Congress enacted GDUFA to ensure patients have access to safe, high‑quality, and affordable generic drugs. GDUFA enables the FDA to assess industry user fees to bring greater predictability and timeliness to the review of generic‑drug applications.

FY 2025 and FY 2026 User‑Fee Rates

| User Fee Type | FY 2025 | FY 2026 |

|---------------|---------|---------|

| ANDA | $321,920 | $358,247 |

| DMF | $95,084 | $102,584 |

| Program – Large Size | $1,891,664 | $1,918,377 |

| Program – Medium Size | $756,666 | $767,351 |

| Program – Small Size | $189,166 | $191,838 |

| Facility – Domestic API | $41,580 | $43,549 |

| Facility – Foreign API | $56,580 | $58,549 |

| Facility – Domestic FDF | $231,952 | $238,943 |

| Facility – Foreign FDF | $246,952 | $253,943 |

| Facility – Domestic CMO | $55,668 | $57,346 |

| Facility – Foreign CMO | $70,668 | $72,346 |

Background and Legislation

GDUFA was signed into law on July 9 2012 as part of the Food and Drug Administration Safety and Innovation Act (FDASIA).
It is re‑authorized every five years; the most recent re‑authorization (GDUFA III) runs through September 30 2027.
The program was developed through an open process that included public meetings, posting of meeting minutes, and public‑docket comments.

Key purpose: Put the FDA’s generic‑drug program on a firm financial footing and ensure timely access to safe, high‑quality, affordable generic drugs.

Sources for additional background and legislation (selected):

21 U.S.C. § 379j‑42 (fees relating to generic drugs)
H.R. 6833 – Continuing appropriations for FY 2023 (includes GDUFA III)
FDA Reauthorization Act of 2017 (FDARA)
GDUFA III Commitment Letter (performance goals FY 2023‑2027)

Program Fees

What is the generic‑drug applicant program fee?

GDUFA III assesses an annual program fee to each company (and its affiliates) based on the number of approved ANDAs in its portfolio:

| Tier | Approved ANDAs |

|------|----------------|

| Large | 20 or more |

| Medium | 6 – 19 |

| Small | 5 or fewer |

An “affiliate” is any entity that controls, is controlled by, or is under common control with the applicant.

Key dates and procedures

Fee due date: October 1 of the fiscal year (or the next business day if the 1st falls on a weekend/holiday).
Penalty for non‑payment (within 20 calendar days):
1. Placement on a publicly available arrears list.
2. New ANDA submissions by the applicant or its affiliates will not be received.
3. All drugs marketed under any ANDA held by the applicant or its affiliates will be deemed misbranded.
Discontinued ANDAs are still counted unless officially withdrawn.
If affiliated companies together hold ≥ 20 approved ANDAs, they must pay the large fee.
Either the parent or any affiliate may pay the fee on behalf of the parent.

Changes to the approved ANDA list

For FY 2023‑FY 2027, an ANDA is deemed not approved if a withdrawal request is submitted by April 1 of the prior fiscal year.
Consolidations, transfers, or other portfolio changes are evaluated as of October 1.

Reporting requirements

By April 1 each year, each ANDA holder (or its designated affiliate) must submit a list of all approved ANDAs owned by the holder and any affiliates that own ANDAs.

Exclusions

Positron‑emission tomography (PET) drugs and applications submitted by a State or Federal government entity for non‑commercial distribution are exempt.

Payment methods

Create a program‑fee cover sheet via the FDA User‑Fee System and pay by check, wire transfer, or pay.gov.

Facility Fees

Facility‑fee types (GDUFA III)

API facility fee – for owners of facilities that produce an API referenced in an approved generic‑drug submission.
FDF facility fee – for owners of facilities that produce a finished dosage form (FDF) referenced in an approved submission.
CMO facility fee – 24 % of the FDF fee, assessed to owners of FDF facilities that act as contract manufacturers (CMOs).

Foreign facilities pay $15,000 more than domestic facilities to cover the additional cost of overseas inspections.

When are facility fees due?

Annually, on the first business day on or after October 1 (or the first business day after an appropriations act).

Conditions that trigger a fee

The facility is referenced in an approved generic‑drug submission and is engaged in manufacturing or processing an API or FDF.
Facilities referenced only in pending or tentatively approved submissions do not incur a fee.

Exemptions

Facilities that self‑identify only for PET drugs, non‑commercial government submissions, testing, repackaging, or relabeling are not required to pay a fee.

Special situations

If a facility is first identified after the fee‑due date, the fee starts the following fiscal year.
Facilities that cease to be identified in any approved submission no longer incur fees, though any outstanding obligations remain due.

Penalties for non‑payment

No new ANDA or supplement will be received from the responsible party or its affiliates.
No new generic‑drug submission referencing the facility will be received.
Placement on a publicly available arrears list (if not paid within 20 days).
All products manufactured in the non‑paying facility will be deemed misbranded, making their interstate shipment or importation unlawful.

Drug Master File (DMF) Fees

Only Type II API DMFs referenced in a generic‑drug submission after October 1 2012 incur a fee.

When is the fee incurred?

On the earlier of (a) the first generic‑drug submission that references the DMF, or (b) the date the DMF holder requests an initial completeness assessment.

Fee characteristics

One‑time fee per DMF (not per reference).
Due on the date of the first reference or the request for completeness assessment, whichever is earlier.

Penalties for non‑payment

The DMF is deemed unavailable for reference; any ANDA referencing it will not be received.
If the fee remains unpaid > 20 days after notification, the ANDA will be rejected.

Abbreviated New Drug Application (ANDA) Fees

Filing fee due date: the date the application is deemed submitted.
Refunds: FDA refunds 75 % of the filing fee if the ANDA is refused to be received or withdrawn before receipt.
Refund request: submit an online form at https://userfees.fda.gov/fdarefund/.
Resubmission after refusal: requires payment of the full fee again.
RTR (refuse‑to‑receive) resubmissions: considered a new submission and subject to the filing fee; a dispute without resubmission is not.

Penalty for non‑payment

The application or supplement is deemed incomplete and will not be received.

Late payment

If paid > 20 days after the due date, the application is considered submitted on the date all obligations are satisfied, provided no disqualifying conditions exist under 21 CFR 314.101(d)‑(e).

Withdrawal

A 75 % refund is available if the ANDA is withdrawn before receipt.

Definition of “generic‑drug submission”

Includes an ANDA, an amendment to an ANDA, or a Prior‑Approval Supplement (PAS).

API‑information fee

Required when an ANDA contains API manufacturing information not by reference to a Type II DMF.
The fee equals the DMF fee and is assessed once per API‑facility combination.

Example:

| Product | API | Facility (no fee yet) |

|---------|-----|------------------------|

| Drug X | Alpha | 1, 2, 3 |

| | Beta | 1, 2 |

| | Gamma | 1 |

Fee = (3 APIs + 3 extra facilities) × DMF‑fee = 6 × DMF‑fee.

User‑Fee Lists

Annual GDUFA facility fees and generic‑drug applicant program fees are due on the later of (i) the first business day on or after October 1 of each fiscal year, or (ii) the first business day after an appropriations act.

Program‑Fee Parent‑Company Details List (XLS)
Applicant‑Program Fee Arrears List (PDF/XLS)
Facility Arrears List (PDF/XLS)
Facilities with Outstanding Fees (not on arrears list) (PDF/XLS)
Type II DMF – Available for Reference List
GDUFA Backlog Arrears List
GDUFA Paid Facilities List

(Links to the above documents are available on the FDA website.)

Payment Information and Cover Sheet

When is a GDUFA cover sheet required?

For each of the following human generic‑drug user fees:

Generic‑drug applicant program fee
ANDA filing fee
Type II API DMF fee (if not previously paid)
Facility fee (API, FDF, or CMO)

Note: A cover sheet is not required for all ANDA amendments and PAS; only for those adding API‑information not by reference to a DMF.

How to create a cover sheet

Access the FDA User‑Fee System (Chrome, Firefox, or Edge).
Register the organization and create a user account.
Complete the cover‑sheet questionnaire.
Submit; a User‑Fee Payment I.D. Number (PIN) beginning with “GD” is generated and must be referenced in the payment.

Payment options

| Method | Details |

|--------|---------|

| Pay.gov | Electronic payment after cover‑sheet submission; click “Pay Now.” |

| Wire Transfer | Use the following banking details: Bank: U.S. Department of Treasury (TREAS NYC) Account #: 75060099 Routing #: 021030004 SWIFT: FRNYUS33 Beneficiary: FDA, 10903 New Hampshire Ave Bldg 75, Room #1427, Silver Spring, MD 20903 Reference: include the PIN. |

Refunds – Request via the FDA User‑Fee Refund portal within 180 calendar days of payment.

Transfers – “Transfer” of a fee from a closed fiscal year is not permitted; refunds are issued instead. Transfers within the same open fiscal year may be allowed (request via Form FDA 3914).

Re‑authorization Activities

GDUFA IV – Fiscal Years 2028‑2032
GDUFA III – Re‑authorization (current)
GDUFA II – FY 2018‑2022
GDUFA I – FY 2013‑2017

Related Information

GDUFA Financial Reports – detailed financial statements.
GDUFA Performance Reports – agency‑wide performance metrics.
GDUFA 5‑Year Financial Plans – future budgeting outlook.

Contact

Generic‑Drug User Fee staff: [email protected] | 301‑796‑7900
User‑Fee Helpdesk: [email protected] | 301‑796‑7200
FDA Division of Drug Information: 855‑543‑3784
General GDUFA inquiries: [email protected]
Generic‑drug questions: [email protected]

Content current as of 02/13/2026

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FY 2025 and FY 2026 User‑Fee Rates

| User Fee Type | FY 2025 | FY 2026 |

|---------------|---------|---------|

| ANDA | $321,920 | $358,247 |

| DMF | $95,084 | $102,584 |

| Program – Large Size | $1,891,664 | $1,918,377 |

| Program – Medium Size | $756,666 | $767,351 |

| Program – Small Size | $189,166 | $191,838 |

| Facility – Domestic API | $41,580 | $43,549 |

| Facility – Foreign API | $56,580 | $58,549 |

| Facility – Domestic FDF | $231,952 | $238,943 |

| Facility – Foreign FDF | $246,952 | $253,943 |

| Facility – Domestic CMO | $55,668 | $57,346 |

| Facility – Foreign CMO | $70,668 | $72,346 |

Background and Legislation

GDUFA was signed into law on July 9 2012 as part of the Food and Drug Administration Safety and Innovation Act (FDASIA).
It is re‑authorized every five years; the most recent re‑authorization (GDUFA III) runs through September 30 2027.
The program was developed through an open process that included public meetings, posting of meeting minutes, and public‑docket comments.

Key purpose: Put the FDA’s generic‑drug program on a firm financial footing and ensure timely access to safe, high‑quality, affordable generic drugs.

Sources for additional background and legislation (selected):

21 U.S.C. § 379j‑42 (fees relating to generic drugs)
H.R. 6833 – Continuing appropriations for FY 2023 (includes GDUFA III)
FDA Reauthorization Act of 2017 (FDARA)
GDUFA III Commitment Letter (performance goals FY 2023‑2027)

Program Fees

What is the generic‑drug applicant program fee?

GDUFA III assesses an annual program fee to each company (and its affiliates) based on the number of approved ANDAs in its portfolio:

| Tier | Approved ANDAs |

|------|----------------|

| Large | 20 or more |

| Medium | 6 – 19 |

| Small | 5 or fewer |

An “affiliate” is any entity that controls, is controlled by, or is under common control with the applicant.

Key dates and procedures

Fee due date: October 1 of the fiscal year (or the next business day if the 1st falls on a weekend/holiday).
Penalty for non‑payment (within 20 calendar days):
1. Placement on a publicly available arrears list.
2. New ANDA submissions by the applicant or its affiliates will not be received.
3. All drugs marketed under any ANDA held by the applicant or its affiliates will be deemed misbranded.
Discontinued ANDAs are still counted unless officially withdrawn.
If affiliated companies together hold ≥ 20 approved ANDAs, they must pay the large fee.
Either the parent or any affiliate may pay the fee on behalf of the parent.

Changes to the approved ANDA list

For FY 2023‑FY 2027, an ANDA is deemed not approved if a withdrawal request is submitted by April 1 of the prior fiscal year.
Consolidations, transfers, or other portfolio changes are evaluated as of October 1.

Reporting requirements

By April 1 each year, each ANDA holder (or its designated affiliate) must submit a list of all approved ANDAs owned by the holder and any affiliates that own ANDAs.

Exclusions

Positron‑emission tomography (PET) drugs and applications submitted by a State or Federal government entity for non‑commercial distribution are exempt.

Payment methods

Create a program‑fee cover sheet via the FDA User‑Fee System and pay by check, wire transfer, or pay.gov.

Facility Fees

Facility‑fee types (GDUFA III)

API facility fee – for owners of facilities that produce an API referenced in an approved generic‑drug submission.
FDF facility fee – for owners of facilities that produce a finished dosage form (FDF) referenced in an approved submission.
CMO facility fee – 24 % of the FDF fee, assessed to owners of FDF facilities that act as contract manufacturers (CMOs).

Foreign facilities pay $15,000 more than domestic facilities to cover the additional cost of overseas inspections.

When are facility fees due?

Annually, on the first business day on or after October 1 (or the first business day after an appropriations act).

Conditions that trigger a fee

The facility is referenced in an approved generic‑drug submission and is engaged in manufacturing or processing an API or FDF.
Facilities referenced only in pending or tentatively approved submissions do not incur a fee.

Exemptions

Facilities that self‑identify only for PET drugs, non‑commercial government submissions, testing, repackaging, or relabeling are not required to pay a fee.

Special situations

If a facility is first identified after the fee‑due date, the fee starts the following fiscal year.
Facilities that cease to be identified in any approved submission no longer incur fees, though any outstanding obligations remain due.

Penalties for non‑payment

No new ANDA or supplement will be received from the responsible party or its affiliates.
No new generic‑drug submission referencing the facility will be received.
Placement on a publicly available arrears list (if not paid within 20 days).
All products manufactured in the non‑paying facility will be deemed misbranded, making their interstate shipment or importation unlawful.

Drug Master File (DMF) Fees

Only Type II API DMFs referenced in a generic‑drug submission after October 1 2012 incur a fee.

When is the fee incurred?

On the earlier of (a) the first generic‑drug submission that references the DMF, or (b) the date the DMF holder requests an initial completeness assessment.

Fee characteristics

One‑time fee per DMF (not per reference).
Due on the date of the first reference or the request for completeness assessment, whichever is earlier.

Penalties for non‑payment

The DMF is deemed unavailable for reference; any ANDA referencing it will not be received.
If the fee remains unpaid > 20 days after notification, the ANDA will be rejected.

Abbreviated New Drug Application (ANDA) Fees

Filing fee due date: the date the application is deemed submitted.
Refunds: FDA refunds 75 % of the filing fee if the ANDA is refused to be received or withdrawn before receipt.
Refund request: submit an online form at https://userfees.fda.gov/fdarefund/.
Resubmission after refusal: requires payment of the full fee again.
RTR (refuse‑to‑receive) resubmissions: considered a new submission and subject to the filing fee; a dispute without resubmission is not.

Penalty for non‑payment

The application or supplement is deemed incomplete and will not be received.

Late payment

If paid > 20 days after the due date, the application is considered submitted on the date all obligations are satisfied, provided no disqualifying conditions exist under 21 CFR 314.101(d)‑(e).

Withdrawal

A 75 % refund is available if the ANDA is withdrawn before receipt.

Definition of “generic‑drug submission”

Includes an ANDA, an amendment to an ANDA, or a Prior‑Approval Supplement (PAS).

API‑information fee

Required when an ANDA contains API manufacturing information not by reference to a Type II DMF.
The fee equals the DMF fee and is assessed once per API‑facility combination.

Example:

| Product | API | Facility (no fee yet) |

|---------|-----|------------------------|

| Drug X | Alpha | 1, 2, 3 |

| | Beta | 1, 2 |

| | Gamma | 1 |

Fee = (3 APIs + 3 extra facilities) × DMF‑fee = 6 × DMF‑fee.

User‑Fee Lists

Program‑Fee Parent‑Company Details List (XLS)
Applicant‑Program Fee Arrears List (PDF/XLS)
Facility Arrears List (PDF/XLS)
Facilities with Outstanding Fees (not on arrears list) (PDF/XLS)
Type II DMF – Available for Reference List
GDUFA Backlog Arrears List
GDUFA Paid Facilities List

(Links to the above documents are available on the FDA website.)

Payment Information and Cover Sheet

When is a GDUFA cover sheet required?

For each of the following human generic‑drug user fees:

Generic‑drug applicant program fee
ANDA filing fee
Type II API DMF fee (if not previously paid)
Facility fee (API, FDF, or CMO)

Note: A cover sheet is not required for all ANDA amendments and PAS; only for those adding API‑information not by reference to a DMF.

How to create a cover sheet

Access the FDA User‑Fee System (Chrome, Firefox, or Edge).
Register the organization and create a user account.
Complete the cover‑sheet questionnaire.
Submit; a User‑Fee Payment I.D. Number (PIN) beginning with “GD” is generated and must be referenced in the payment.

Payment options

| Method | Details |

|--------|---------|

| Pay.gov | Electronic payment after cover‑sheet submission; click “Pay Now.” |

Refunds – Request via the FDA User‑Fee Refund portal within 180 calendar days of payment.

Re‑authorization Activities

GDUFA IV – Fiscal Years 2028‑2032
GDUFA III – Re‑authorization (current)
GDUFA II – FY 2018‑2022
GDUFA I – FY 2013‑2017

Related Information

GDUFA Financial Reports – detailed financial statements.
GDUFA Performance Reports – agency‑wide performance metrics.
GDUFA 5‑Year Financial Plans – future budgeting outlook.

Contact

Generic‑Drug User Fee staff: [email protected] | 301‑796‑7900
User‑Fee Helpdesk: [email protected] | 301‑796‑7200
FDA Division of Drug Information: 855‑543‑3784
General GDUFA inquiries: [email protected]
Generic‑drug questions: [email protected]

Content current as of 02/13/2026

Healthcare Pulse

Generic Drug User Fee Amendments

Why It Matters

Key Takeaways

Pulse Analysis

Ask Pulse AI:

Generic Drug User Fee Amendments

FY 2025 and FY 2026 User‑Fee Rates

Background and Legislation

Program Fees

Facility Fees

Drug Master File (DMF) Fees

Abbreviated New Drug Application (ANDA) Fees

User‑Fee Lists

Payment Information and Cover Sheet

Re‑authorization Activities

Related Information

Contact

Comments

Healthcare Pulse

Generic Drug User Fee Amendments

Why It Matters

Key Takeaways

Pulse Analysis

Ask Pulse AI:

Generic Drug User Fee Amendments

FY 2025 and FY 2026 User‑Fee Rates

Background and Legislation

Program Fees

Facility Fees

Drug Master File (DMF) Fees

Abbreviated New Drug Application (ANDA) Fees

User‑Fee Lists

Payment Information and Cover Sheet

Re‑authorization Activities

Related Information

Contact

Comments

Healthcare Pulse

Generic Drug User Fee Amendments

Why It Matters

Key Takeaways

Pulse Analysis

Ask Pulse AI:

Generic Drug User Fee Amendments

FY 2025 and FY 2026 User‑Fee Rates

Background and Legislation

Program Fees

Facility Fees

Drug Master File (DMF) Fees

Abbreviated New Drug Application (ANDA) Fees

User‑Fee Lists

Payment Information and Cover Sheet

Re‑authorization Activities

Related Information

Contact

Comments

Healthcare Pulse

Generic Drug User Fee Amendments

Why It Matters

Key Takeaways

Pulse Analysis

Ask Pulse AI:

Generic Drug User Fee Amendments

FY 2025 and FY 2026 User‑Fee Rates

Background and Legislation

Program Fees

Facility Fees

Drug Master File (DMF) Fees

Abbreviated New Drug Application (ANDA) Fees

User‑Fee Lists

Payment Information and Cover Sheet

Re‑authorization Activities

Related Information

Contact

Comments

FY 2025 and FY 2026 User‑Fee Rates

FY 2025 and FY 2026 User‑Fee Rates