Medicare Part D spending · FDA facts · help paying
Dupixent (dupilumab): what Medicare Part D spends and the dated federal facts we hold
CMS's Medicare Part D spending dataset lists Dupixent under 2 names; the sum of their gross spending is $2.49 billion in 2024, across 621,396 claims. 5 assistance programs list dupilumab, each with its income ceiling and when we read it. 4 non-manufacturing label changes are dated in the last 12 months in the FDA's file. The FDA's enforcement reports name this drug's packages in 1 recall entry.
Medicare Part D spending
CMS's Medicare Part D spending dataset lists Dupixent under 2 names; the sum of their gross spending is $2.49 billion in 2024, across 621,396 claims. CMS's dataset states spending is gross drug cost and does not reflect manufacturers' rebates or other price concessions. Spending is the total paid by Medicare, plans and beneficiaries for the drug's claims, not what a patient pays.
| Year | Gross spending | Claims |
|---|---|---|
| 2024 | $2.49 billion | 621,396 |
| 2023 | $1.71 billion | 434,823 |
| 2022 | $1.08 billion | 290,401 |
| 2021 | $732.70 million | 209,554 |
| 2020 | $480.15 million | 141,558 |
Names CMS reports it under
| Name in the CMS file | Year | Gross spending | Claims |
|---|---|---|---|
| Dupixent Pen | 2024 | $1.80 billion | 450,526 |
| Dupixent Syringe | 2024 | $687.12 million | 170,870 |
Source: CMS Medicare Part D spending by drug (data-year-2024, modified 2026-06-25), read November 7, 2026. CMS dataset page. All manufacturers combined; the figures are a drug-level aggregate of claims and say nothing about a formulary or coverage.
Biosimilar status
- Dupixent (dupilumab) is a reference product in the FDA Purple Book (BLA 761055, approved March 28, 2017). The Purple Book lists 0 biosimilars and 0 interchangeable products that name it as their reference product.
This is what the FDA Purple Book lists on the read date. It is a record, not a forecast of when any product will launch or be substituted.
Source: FDA Purple Book (purplebook-2026-10), read November 7, 2026. Purple Book data file.
Rare-disease (orphan) designations
The FDA's orphan drug database lists 4 designations for dupilumab, 3 with an approval recorded. A designation is not an approval and not a statement that the drug treats the condition; the status column is the database's own.
| Designated | Designated use | Status | Sponsor |
|---|---|---|---|
| July 14, 2026 | treatment of Netherton syndrome (NS) | Designated | Regeneron Pharmaceuticals, Inc. |
| August 21, 2019 | Treatment of bullous pemphigoid | Designated/Approved | Regeneron Pharmaceuticals, Inc. |
| September 5, 2017 | Treatment of eosinophilic esophagitis | Designated/Approved | Regeneron Pharmaceuticals, Inc. |
| September 5, 2017 | Treatment of eosinophilic esophagitis | Designated/Approved | Regeneron Pharmaceuticals, Inc. |
Source: FDA Orphan Drug Designations and Approvals database, read November 7, 2026. FDA orphan drug search.
Medicaid use by state
CMS's State Drug Utilization Data records, for 2025, how many prescriptions each state's Medicaid program paid for under this drug's packages and what it reimbursed. The 4 states with the largest reimbursement are shown. Reimbursement is before the rebates manufacturers pay states, so it is not a net cost and not a price a patient pays.
| State | Medicaid-paid prescriptions | Medicaid reimbursed | Covers |
|---|---|---|---|
| OH | 1,287 | $4,482,711 | Fee-for-service only |
| UT | 117 | $463,946 | Fee-for-service only |
| VT | 79 | $303,175 | All record types |
| TN | 74 | $94 | All record types |
Where the publisher suppresses small managed-care cells, a state's figure covers fee-for-service claims only and understates use (2 state and package figures are marked that way here). A state missing from the table means its figures were suppressed or not reported, not zero use. 206 older-year figures are held and left out of the table.
Source: CMS State Drug Utilization Data (State Drug Utilization Data 2025, modified 2026-07-13T15:28:32Z), read November 7, 2026. CMS dataset page. State-reported data compiled by CMS; aggregate by state and package, no provider or patient data.
Medicaid spending
CMS's Medicaid spending dataset reports $2.37 billion for Dupixent in 2024. CMS's dataset states spending includes Federal and State reimbursement and dispensing fees and is not reduced by Medicaid rebates paid to the states. Spending is what Medicaid paid, not what a patient pays.
| Year | Spending | Claims |
|---|---|---|
| 2024 | $2.37 billion | 626,913 |
| 2023 | $1.83 billion | 509,431 |
| 2022 | $1.15 billion | 347,869 |
| 2021 | $697.95 million | 223,134 |
| 2020 | $390.16 million | 128,386 |
Source: CMS Medicaid spending by drug (data-year-2024, modified 2026-06-25), read November 7, 2026. CMS dataset page. A national drug-level aggregate; it says nothing about any state's coverage rules.
Federal formulary status
VA national formulary
The VA's national formulary files list the ingredient dupilumab, which covers every maker's product with that ingredient, not only Dupixent. Each row is a VA national drug file entry and its status.
| VA entry | Status | Active NDCs |
|---|---|---|
| DUPILUMAB INJ,SOLN | Non-formulary | 14 |
Source: VA Pharmacy Benefits Management national formulary (va-formulary-2026-09), read November 7, 2026. VA formulary page.
Where help paying exists
Programs in our finder that list dupilumab. Each shows its income ceiling, when we read it and whether we checked it against the program's own document. Eligibility is decided by the program, not by us.
- Regeneron/Sanofi Dupixent MyWay manufacturer
No published income limit: DUPIXENT MyWay reviews eligibility case by case
Limit read October 19, 2026. - Dupixent Copay Card manufacturer
No income limit in our data
Figure not yet re-read on the program's own page. - HealthWell Foundation nonprofit
Up to 300% to 500% FPL depending on the disease fund; many funds close to new patients
Ceiling matched against the program's page text, November 6, 2026.Status. The HealthWell Foundation homepage lists disease funds as Open or Closed when read. Closed funds include Type 2 Diabetes, Migraine and Multiple Sclerosis - Medicare Access; open funds include Multiple Myeloma - Medicare Access, which the page says offers up to $8,000 in prescription drug copayment or Medicare Part B premium assistance. The page carries no fund-level date; the status is as of the read. (read November 7, 2026)
- Good Days (formerly Chronic Disease Fund) nonprofit
Income at or below 500% of the poverty level
Figure not yet re-read on the program's own page. - TAF Cares (The Assistance Fund) nonprofit
Income at or below 500% of the poverty level
Figure not yet re-read on the program's own page.
Check where your income sits against each ceiling: open the assistance finder. See what has changed and when we last verified each program on the program status board.
Label changes
FDA actions on the applications behind Dupixent dated since November 11, 2025, leaving out manufacturing (CMC) changes. 4 changes in the window.
| Date | Class | Application | Submissions | FDA documents |
|---|---|---|---|---|
| July 15, 2026 | Labeling | BLA761055 | 76 | Label (PDF) posted September 2, 2026FDA letter posted September 3, 2026 |
| April 22, 2026 | Efficacy | BLA761055 | 74 | Label (PDF) posted April 24, 2026FDA letter posted April 24, 2026 |
| April 16, 2026 | Labeling | BLA761055 | 82 | Label (PDF) posted April 21, 2026FDA letter posted April 20, 2026 |
| February 23, 2026 | Efficacy | BLA761055 | 75 | Label (PDF) posted February 24, 2026FDA letter posted February 24, 2026 |
Source: FDA Drugs@FDA data file, read November 7, 2026. Dates are the FDA action dates; the documents are on FDA's own site. FDA data file. All recent changes across these drugs: label changes feed.
Safety notices
FDA enforcement report entries that name a package of Dupixent by its NDC: 1 entry, newest first. FDA assigns each a class by health risk: Class I is the most serious and Class III the least. An entry records what the recalling firm reported and FDA classified; it is not advice about any package you hold.
| Reported | Class | Status | Recalling firm | Reason (shortened) | Packages named |
|---|---|---|---|---|---|
| May 16, 2018D-0760-2018 | Class II | Terminated | Kroger Specialty Pharmacy, Inc. | Lack of Processing Controls. | 1 |
Source: openFDA drug enforcement reports, file read November 7, 2026. openFDA data file. All recent recalls across these drugs: drug recalls feed.
Questions
Does Medicare have a negotiated price for Dupixent?
The CMS negotiated-price file we read does not list Dupixent, so this page shows no negotiated price. A drug appears in that file only when CMS selects it for negotiation, and not being listed says nothing about what it costs a patient.
Is there help paying for Dupixent?
5 assistance programs list it in our finder. Eligibility depends on income, coverage and the program's current rules; each program's own page decides.
How much does Medicare Part D spend on Dupixent?
CMS's Medicare Part D spending dataset lists Dupixent under 2 names; the sum of their gross spending is $2.49 billion in 2024, across 621,396 claims. CMS's dataset states spending is gross drug cost and does not reflect manufacturers' rebates or other price concessions. Spending is the total paid by Medicare, plans and beneficiaries for the drug's claims, not what a patient pays.
For developers: this drug as data
One call returns the generic-entry upper bound, label history, recalls, trials, assistance and Part D spending, and where facts exist the FDA safety program (REMS), DEA schedule, orphan designations, safety notices and Medicaid use by state, each with receipts.
Example file: https://omnirx.org/api/v1/dossier/dupixent.json
The licence page sets out what a data licence covers, and the API page documents these files.
Evaluation files with receipts; contract may change; not clinical advice.
Sources and terms. This drug is not in the CMS negotiated-price file, so no price source is used. Program details read from each program's own pages; CMS Medicare Part D spending by drug; CMS Medicaid spending by drug; TRICARE and VA formulary files; FDA Purple Book; FDA Drugs@FDA and Orange Book data files; openFDA drug enforcement reports. Figures are stored with their sources in the OmniRx library (edition 2026-11). Free to cite with attribution. Not medical, legal or financial advice. Report an error through the contact page. Licence the data.