Prescription medicine
Dimethyl fumarate Brand names: Tecfidera
Dimethyl fumarate (Tecfidera) is a prescription medicine with an FDA approval on record since 2013. FDA's NDC Directory lists it from 19 generic labelers, and pharmacies paid $0.467 per dimethyl fumarate DR 240 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the dimethyl fumarate FDA label on DailyMed (effective July 29, 2025, Macleods Pharmaceuticals Limited); the NDA 204063 record on Drugs@FDA; every dimethyl fumarate label on DailyMed.
Highlights of the record
FDA label of July 29, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageDimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Forms and strengths
- 120 mg
- 240 mg
Delayed-release capsule; kit; capsule.
On the market
- Earliest approval on file
- March 27, 2013 Tecfidera, Biogen; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 17 first August 17, 2020; 12 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 20 of which 19 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- November 16, 2035 Tecfidera capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.467 per capsule Dimethyl fumarate DR 240 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2020 0 Class I among all firms' recalls; latest June 23, 2020
- FAERS reports
- 122,284 through July 30, 2026
What is dimethyl fumarate used for?
From the label: indications and usageDimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Dimethyl fumarate delayed-release capsules is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Conditions named in the indications of dimethyl fumarate's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Dimethyl Fumarate), Macleods Pharmaceuticals Limited, effective July 29, 2025 (SPL set f8ada3e3-55c0-43e3-95b9-c6d11ffc42dd), via openFDA; the full label on DailyMed
Is there a generic for dimethyl fumarate (Tecfidera)?
The FDA approved the first generic dimethyl fumarate on August 17, 2020. 17 generic applications are approved; 12 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists dimethyl fumarate from 19 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 9 patents for Tecfidera capsules, the last expiring on November 16, 2035. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2013 earliest approval on file
- 2020 first generic approved
- 2035 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for dimethyl fumarate (Tecfidera)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.467 per Dimethyl fumarate DR 240 mg capsule, down 43% from $0.819 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Dimethyl fumarate DR 240 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Dimethyl fumarate DR 120 mg capsule | Generic | $0.428 per capsule | $12.85 | -63% |
| Dimethyl fumarate DR 240 mg capsule | Generic | $0.467 per capsule | $14.02 | -43% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has dimethyl fumarate been recalled?
The FDA's Enforcement Report lists 1 recall naming dimethyl fumarate since 2020: 0 Class I (the most serious), 0 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 23, 2020 | Class III | Biogen MA Inc. | cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the dimethyl fumarate label say about other medicines?
The dimethyl fumarate label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name dimethyl fumarate. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | warnings and precautions | Alternatively, administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to dimethyl fumarate delayed-release capsules dosing may reduce the incidence or severity of flushing [see Dosing and Administration ( 2.1 ) and Clinical Pharmacology ( 12.3 )]. |
| Natalizumab | warnings and precautions | The patient had no other identified systemic medical conditions resulting in compromised immune system function and had not previously been treated with natalizumab, which has a known association with PML. |
Other labels that name dimethyl fumarate
Source: FDA drug label (Dimethyl Fumarate), Macleods Pharmaceuticals Limited, effective July 29, 2025 (SPL set f8ada3e3-55c0-43e3-95b9-c6d11ffc42dd), via openFDA; the full label on DailyMed
What do FAERS reports show for dimethyl fumarate?
The FDA Adverse Event Reporting System holds 122,284 reports that list dimethyl fumarate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,169 are coded as a death and 22,867 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as dimethyl fumarate?
8 other medicines are given the same way (oral) and in the same FDA class as dimethyl fumarate or labeled mainly for the same use (multiple sclerosis), the same class first. Multiple sclerosis lists all 23 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Teriflunomide | Multiple sclerosis | 15 labelers | $0.233 per tablet 14 mg tablet | No current entry |
| Fingolimod | Multiple sclerosis | 21 labelers | $1.58 per capsule 0.5 mg capsule | No current entry |
| Dalfampridine | Multiple sclerosis | 9 labelers | $0.399 per tablet 10 mg tablet | No current entry |
| Cladribine | Multiple sclerosis | 3 labelers | n/a | No current entry |
| Siponimod | Multiple sclerosis | none listed | n/a | No current entry |
| Ponesimod | Multiple sclerosis | none listed | n/a | No current entry |
| Diroximel fumarate | Multiple sclerosis | none listed | n/a | No current entry |
| Monomethyl fumarate | Multiple sclerosis | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as dimethyl fumarate
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does dimethyl fumarate compare with medicines for the same use?
1 side-by-side page set dimethyl fumarate beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to dimethyl fumarate
- 8 medicines for the same use
- Dimethyl fumarate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other