Prescription medicine
Monomethyl fumarate Brand names: Bafiertam
Monomethyl fumarate (Bafiertam) is a prescription medicine with an FDA approval on record since 2020. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the monomethyl fumarate FDA label on DailyMed (effective July 16, 2026, Banner Life Sciences LLC); the NDA 210296 record on Drugs@FDA; every monomethyl fumarate label on DailyMed.
Highlights of the record
FDA label of July 16, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageBAFIERTAM 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.
Forms and strengths
- 95 mg
Capsule.
On the market
- Earliest approval on file
- April 28, 2020 Bafiertam, Banner Life Sciences; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- February 27, 2035 Bafiertam capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 926 through July 30, 2026
What is monomethyl fumarate used for?
From the label: indications and usageBAFIERTAM 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. BAFIERTAM 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 monomethyl fumarate's FDA labels, with every medicine labeled for each:
Source: FDA drug label (BAFIERTAM), Banner Life Sciences LLC, effective July 16, 2026 (SPL set a161f9d4-70f1-4097-957a-eafb35d3274f), via openFDA; the full label on DailyMed
Is there a generic for monomethyl fumarate (Bafiertam)?
No generic monomethyl fumarate is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 21 patents for Bafiertam capsules, the last expiring on February 27, 2035. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2020 earliest approval on file
- 2035 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the monomethyl fumarate label say about other medicines?
The monomethyl fumarate label names 4 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name monomethyl 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 | Studies with dimethyl fumarate show that administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to dosing may reduce the incidence or severity of flushing [see Clinical Pharmacology ( 12.3 )]. |
| Dimethyl fumarate | contraindications | CONTRAINDICATIONS BAFIERTAM is contraindicated in patients: with known hypersensitivity to monomethyl fumarate, dimethyl fumarate, diroximel fumarate, or to any of the excipients of BAFIERTAM. |
| Diroximel fumarate | contraindications | CONTRAINDICATIONS BAFIERTAM is contraindicated in patients: with known hypersensitivity to monomethyl fumarate, dimethyl fumarate, diroximel fumarate, or to any of the excipients of BAFIERTAM. |
| 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. |
Source: FDA drug label (BAFIERTAM), Banner Life Sciences LLC, effective July 16, 2026 (SPL set a161f9d4-70f1-4097-957a-eafb35d3274f), via openFDA; the full label on DailyMed
What do FAERS reports show for monomethyl fumarate?
The FDA Adverse Event Reporting System holds 926 reports that list monomethyl fumarate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3 are coded as a death and 48 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 monomethyl fumarate?
8 other medicines are given the same way (oral) and in the same FDA class as monomethyl 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 |
|---|---|---|---|---|
| Dimethyl fumarate | Multiple sclerosis | 19 labelers | $0.467 per capsule 240 mg capsule | No current entry |
| 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 |
Every medicine labeled for the same conditions as monomethyl fumarate
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to monomethyl fumarate
- 8 medicines for the same use
- Monomethyl fumarate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other