Medicare Part D spending · FDA facts · help paying
Tecfidera (dimethyl fumarate): what Medicare Part D spends and the dated federal facts we hold
CMS's Medicare Part D spending dataset reports gross spending on Tecfidera of $162.84 million in 2024, across 16,641 claims and 2,117 beneficiaries. The FDA's enforcement reports name this drug's packages in 2 recall entries.
When could a generic arrive
Each date below is an upper bound from listed patent and exclusivity dates, not a forecast of when a generic will launch. Basis: latest of all listed patent and exclusivity expiries in this Orange Book edition; an upper bound from listed dates only, not a forecast of launch (litigation, settlements, delisting, tentative approvals and 180-day status are not modelled).
| Application | Product | Latest listed patent expiry | Latest listed exclusivity expiry | Latest of the two | Set by |
|---|---|---|---|---|---|
| NDA204063 | Tecfidera | November 16, 2035 | none listed | November 16, 2035 | patent 10959972; 18 dated entries listed |
Source: FDA Orange Book data files, edition September 2026, read November 7, 2026; patent listings are as submitted by applicants and not verified by FDA. FDA data file.
Medicare Part D spending
CMS's Medicare Part D spending dataset reports gross spending on Tecfidera of $162.84 million in 2024, across 16,641 claims and 2,117 beneficiaries. 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 | Beneficiaries | Average spending per claim |
|---|---|---|---|---|
| 2024 | $162.84 million | 16,641 | 2,117 | $9,786 |
| 2023 | $234.52 million | 23,080 | 3,154 | $10,161 |
| 2022 | $343.23 million | 38,126 | 4,651 | $9,002 |
| 2021 | $569.20 million | 63,761 | 8,187 | $8,927 |
| 2020 | $1.05 billion | 108,629 | 14,663 | $9,712 |
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.
Rare-disease (orphan) designations
The FDA's orphan drug database lists 1 designation for dimethyl fumarate. 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 |
|---|---|---|---|
| September 11, 2013 | Treatment of Friedreich's Ataxia | Designated | Ixchel Pharma, LLC |
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 2024, how many prescriptions each state's Medicaid program paid for under this drug's packages and what it reimbursed. The 10 states with the largest reimbursement are shown of 14 with data. 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 |
|---|---|---|---|
| IL | 757 | $6,569,521 | Fee-for-service only |
| MI | 241 | $2,180,853 | Fee-for-service only |
| NY | 183 | $2,035,862 | All record types |
| PA | 178 | $1,550,712 | All record types |
| CA | 111 | $1,160,542 | All record types |
| NC | 105 | $1,086,828 | Fee-for-service only |
| OH | 106 | $969,092 | Fee-for-service only |
| TX | 85 | $776,414 | All record types |
| MA | 81 | $765,724 | Fee-for-service only |
| VA | 83 | $736,506 | All record types |
Where the publisher suppresses small managed-care cells, a state's figure covers fee-for-service claims only and understates use (6 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.
Source: CMS State Drug Utilization Data (State Drug Utilization Data 2024, modified 2026-07-13T15:37:28Z), 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 $26.97 million for Tecfidera 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 | $26.97 million | 2,970 |
| 2023 | $45.19 million | 5,115 |
| 2022 | $89.43 million | 10,613 |
| 2021 | $136.12 million | 15,947 |
| 2020 | $284.35 million | 34,268 |
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 dimethyl fumarate, which covers every maker's product with that ingredient, not only Tecfidera. Each row is a VA national drug file entry and its status.
| VA entry | Status | Active NDCs |
|---|---|---|
| DIMETHYL FUMARATE CAP,EC | National Formulary | 34 |
Source: VA Pharmacy Benefits Management national formulary (va-formulary-2026-09), read November 7, 2026. VA formulary page.
Where help paying exists
No program in our finder currently lists this drug as open to new patients.
Label changes
The FDA file lists no non-manufacturing label change for these applications since November 11, 2025. The most recent one it lists is dated March 12, 2024 (Labeling).
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 Tecfidera by its NDC: 2 entries, 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 |
|---|---|---|---|---|---|
| July 15, 2020D-1381-2020 | Class III | Terminated | Biogen MA Inc. | cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control. | 1 |
| May 16, 2018D-0767-2018 | 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 Tecfidera?
The CMS negotiated-price file we read does not list Tecfidera, 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 Tecfidera?
No program in our finder lists this drug yet.
When could a generic version of Tecfidera arrive?
For Tecfidera, the FDA's Orange Book (edition September 2026) lists these latest patent or exclusivity expiry dates by application: NDA204063, November 16, 2035. Each date is an upper bound from listed patent and exclusivity dates, not a forecast of when a generic will launch. Basis: latest of all listed patent and exclusivity expiries in this Orange Book edition; an upper bound from listed dates only, not a forecast of launch (litigation, settlements, delisting, tentative approvals and 180-day status are not modelled).
How much does Medicare Part D spend on Tecfidera?
CMS's Medicare Part D spending dataset reports gross spending on Tecfidera of $162.84 million in 2024, across 16,641 claims and 2,117 beneficiaries. 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/tecfidera.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 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.