Bafiertam Generic: When Will Generic Monomethyl Be Available?
This page is aggregated from FDA records, court filings and company announcements. Coded and designed by Dr. Brian Staiger, PharmD, BCPS
Updated October 9, 2026 How we build our data
Bafiertam Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? February 2035 About 8.5 years away Why then?
- Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
- When does the last patent end? February 2035 21 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic monomethyl fumarate is expected to be available in February 2035, about 8.5 years away. None is for sale yet.
Why February 2035?
It is when Bafiertam’s patents 9,326,947, 9,326,965, 9,511,043, 9,517,209 and 17 more end. They cover the product’s formulation and a way of using it, and once they end, generics can go on sale as soon as the FDA approves them. We rate it toss-up: still unsettled. Just as likely to slip as to hold.
Why hasn’t the FDA approved a generic yet?
That is normal before a launch. The FDA usually can’t give a generic its final approval while a patent or exclusivity still blocks it, so final approval often comes close to the day the generic can be sold. No company holds a “tentative” approval yet either (the FDA’s word for a generic that is ready but still blocked).
Will the generic cost less?
Usually, but no company is recorded as having applied to make one yet, and a single company usually brings only a modest drop. See the price pattern
What should I do now?
Keep taking Bafiertam as prescribed. When a generic arrives, your pharmacy may switch you to it automatically, and it may look different. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Bafiertam by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Toss-up Still unsettled. Just as likely to slip as to hold.
- Price competition
- None filed yet No filers on record
- Brand sales
- $41M a yearSmaller seller
- FDA approved 2020 April 2020 FDA Orange Book
- Patents listed 21 last runs to February 2035 FDA Orange Book
- Medicare Part D spent $15.5M in 2025, for 275 people CMS Part D Spending by Drug
- Medicaid prescriptions 135 in the last four reported quarters, $1.2M CMS Medicaid drug utilization, to Q1 2026
Bafiertam’s Road to a Generic
Bafiertam has had the market to itself since the FDA approved it in April 2020 (Banner Life Sciences LLC). Its 21 listed patents run to February 2035.
The first generic of Bafiertam is expected in February 2035.
Why that month: patents 9,326,947, 9,326,965, 9,511,043, 9,517,209 and 17 more, on the product’s formulation and a way of using it, end then.
Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.
Bafiertam Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Bafiertam’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.
The one that matters for a generic launch: patents 9,326,947, 9,326,965, 9,511,043, 9,517,209 and 17 more, which end in February 2035, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 9,326,947 Sets the expected month of generic availability | The product’s formulation | February 2035 | Active |
| 9,326,965 Sets the expected month of generic availability | A way of using it (U-1384) | February 2035 | Active |
| 9,511,043 Sets the expected month of generic availability | A way of using it (U-1384) | February 2035 | Active |
| 9,517,209 Sets the expected month of generic availability | The product’s formulation | February 2035 | Active |
| 9,566,259 Sets the expected month of generic availability | The product’s formulation | February 2035 | Active |
| 9,636,318 Sets the expected month of generic availability | A way of using it (U-1384) | February 2035 | Active |
| 9,636,319 Sets the expected month of generic availability | The product’s formulation | February 2035 | Active |
| 9,814,691 Sets the expected month of generic availability | A way of using it (U-1384) | February 2035 | Active |
| 9,814,692 Sets the expected month of generic availability | A way of using it (U-1384) | February 2035 | Active |
| 9,820,960 Sets the expected month of generic availability | The product’s formulation | February 2035 | Active |
| 9,820,961 Sets the expected month of generic availability | The product’s formulation; a way of using it (U-1384) | February 2035 | Active |
| 10,098,863 Sets the expected month of generic availability | The product’s formulation; a way of using it (U-1384) | February 2035 | Active |
| 10,105,335 Sets the expected month of generic availability | The product’s formulation | February 2035 | Active |
| 10,105,336 Sets the expected month of generic availability | The product’s formulation; a way of using it (U-1384) | February 2035 | Active |
| 10,105,337 Sets the expected month of generic availability | The product’s formulation | February 2035 | Active |
| 10,918,615 Sets the expected month of generic availability | The product’s formulation; a way of using it (U-1384) | February 2035 | Active |
| 10,918,616 Sets the expected month of generic availability | A way of using it (U-1384) | February 2035 | Active |
| 10,918,617 Sets the expected month of generic availability | The product’s formulation | February 2035 | Active |
| 10,945,985 Sets the expected month of generic availability | The product’s formulation | February 2035 | Active |
| 11,590,095 Sets the expected month of generic availability | A way of using it (U-1384) | February 2035 | Active |
| 11,903,918 Sets the expected month of generic availability | A way of using it (U-1384) | February 2035 | Active |
Source: FDA Orange Book, application 210296. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Monomethyl Fumarate
Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.
Applied to the FDA
No company is recorded as having applied to the FDA to make a generic Bafiertam yet.
Approved by the FDA
Not yet. The FDA has not approved a generic monomethyl fumarate. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic monomethyl fumarate for sale with the FDA.
Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).
Bafiertam Price: What Pharmacies Pay and What Generics Usually Do
What a Generic Could Cost
How we estimate it. The national survey of what pharmacies pay (NADAC) has no recent price for Bafiertam, so we cannot show dollars. Here is the FDA’s finding of how far the price pharmacies pay usually falls as generic companies join: about 31% with one company, 44% with two, 73% with four and over 95% with six or more (the typical drop for every drug whose first generic came out from 2015 to 2017).
Median prices pharmacies paid for the generic (invoice prices), compared with the brand’s price before generic entry, from FDA’s 2019 analysis “Generic Competition and Drug Prices”. At the manufacturer’s price FDA found steeper drops (about 39%, 54%, 79% and over 95%), the figures quoted elsewhere on this tracker. A typical pattern, not a price quote for this medicine.
What Medicare and Medicaid Spend on Bafiertam
Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.
Medicare Part D Spending
What Medicare drug plans spent on Bafiertam, before manufacturer rebates.
- $4.5M
- January to March 2026, the latest CMS has posted
For 268 people, about $7,679 per prescription fill - $15.5M
- 2025, the whole year
For 275 people, about $7,624 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $4,492,060 | 268 | $7,678.73 |
| 2025 | $15,469,840 | 275 | $7,624.37 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Bafiertam only, so no generic is counted in it. What CMS says it is used for: Monomethyl fumarate is used to treat multiple sclerosis (MS). It is not a cure for MS, but it may help decrease the number of relapses and prevent or delay disability.
Medicaid Prescriptions by Quarter
135 prescriptions in the four quarters to Q1 2026, $1.2M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 32 | $311,077 |
| Q4 2025 | 30 | $276,610 |
| Q3 2025 | 45 | $449,695 |
| Q2 2025 | 28 | $207,715 |
| Q1 2025 | 22 | $194,242 |
Source: CMS Medicaid State Drug Utilization Data, over Bafiertam’s own package codes.
Bafiertam Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 95MG | Capsule, delayed release | Oral | April 2020 | Prescription reference product |
Source: FDA Orange Book, Banner Life Sciences LLC. Listed for sale today by Banner Life Sciences LLC (FDA NDC Directory).
Bafiertam NDC Codes and Packages
Each Bafiertam package sold today has its own NDC, the product number printed on the box and on the pharmacy label. Open one to see that package’s details, what pharmacies pay for it and its patent timeline.
| NDC | Product | Package | Company |
|---|---|---|---|
| 69387-0001-01 | MONOMETHYL FUMARATE 95 mg/1 capsule | bottle of 120 capsules | Banner Life Sciences LLC |
| 69387-0001-01 | MONOMETHYL FUMARATE 95 mg/1 capsule | bottle of 120 capsules | Banner Life Sciences LLC |
Source: the FDA NDC Directory, current listings only. Only packages sold under Bafiertam’s own FDA approval (NDA 210296) are listed, never a generic. Some codes belong to companies that repackage Bafiertam: it is the same medicine in a different package.
What a Generic Bafiertam Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Bafiertam as usual. When one arrives, there is nothing you need to sign up for.
Your Pharmacy May Switch You Automatically
Every state lets pharmacists fill a brand-name prescription with an FDA-approved generic rated as equivalent to it, and about 19 states require them to, unless your prescriber writes “dispense as written” or “brand medically necessary” on the prescription. Some states ask the pharmacist to tell you, or to get your OK first. A study of every state’s law has the details.
It Will Probably Look Different
US trademark law does not let a generic look exactly like the brand, so the color, shape or markings usually change. The active ingredient, strength and form are the same. An “authorized generic,” made by or for the brand’s own company, can look identical. The FDA explains.
Your Insurance May Change Too
Once a lower-cost version is available, many insurance plans charge more for the brand, or stop covering it. Your plan’s drug list (formulary) says how.
Until a generic is on US pharmacy shelves, be careful with websites that offer “generic Bafiertam”. The FDA warns that unlicensed online pharmacies sell counterfeit and unapproved medicines; its BeSafeRx page shows how to check a pharmacy.
Questions people ask about Bafiertam
Is there a generic for Bafiertam right now?
No. As of October 9, 2026 no generic monomethyl fumarate is listed for sale in the FDA NDC Directory.
When will Bafiertam go generic?
February 2035 is the expected month, and that is toss-up but not certain. It is when Bafiertam’s patents 9,326,947, 9,326,965, 9,511,043, 9,517,209 and 17 more end. They cover the product’s formulation and a way of using it, and once they end, generics can go on sale as soon as the FDA approves them.
Will generic monomethyl fumarate be the same as Bafiertam?
Yes in the ways that matter: the same active ingredient, strength and form, with proof that it reaches your blood the same way. Inactive ingredients can differ, which is why some people notice a different look or taste.
How much will the generic cost?
Nobody can say for sure before launch. No company is recorded as having applied to the FDA to make one yet, and a single company usually brings only a modest drop.
Has the FDA approved a generic Bafiertam?
Not yet. The FDA Orange Book lists no approved generic version of Bafiertam.
When does the Bafiertam patent expire?
The FDA Orange Book lists 21 patents for Bafiertam; the last runs to February 2035. The one behind the expected month is patents 9,326,947, 9,326,965, 9,511,043, 9,517,209 and 17 more, which end in February 2035. A patent date is not the launch date: settlements and court rulings often bring a generic earlier, and FDA approval or a company’s own plans can make it later. The expected month on this page (February 2035) weighs all of that.
Changes to This Projection
- First generic expected February 2035 on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.
Every change to the expected month is logged here with the month we saw it.
Also Going Generic
- Cuvrior BDTrientine TetrahydrochlorideApril 2029
- ValchlorMechlorethamine HydrochlorideJuly 2029
- NatestoTestosteroneMarch 2034
- ZynrelefBupivacaine and MeloxicamApril 2036
- RezdiffraResmetirom2042 to 2043
- IgalmiDexmedetomidine HydrochlorideJanuary 2043
About Bafiertam
- Generic name monomethyl fumarate
- How it is taken By mouth
- Company Banner Life Sciences LLC
- More drugs Brand-name drugs starting with B
- Have a question? A pharmacist answers, free. Ask about Bafiertam
Sources. The expected month: FDA Paragraph IV Patent Certifications list, federal court records, company announcements and securities filings (settlement dates, launch plans, sales). The record on this page: FDA Orange Book, Drugs@FDA (tentative approvals), FDA NDC Directory, CMS Medicare Part D Spending by Drug, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.