Vumerity Generic: When Will Generic Diroximel 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
Vumerity Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? During 2033 Sometime that year Why then?
- Has the FDA approved a generic? November 2025 1 company approved Why not on sale?
- When does the last patent end? October 2033 3 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic diroximel fumarate is expected to be available sometime in 2033. None is for sale yet.
Why 2033?
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. We rate it probable: more likely than not, but it can still move.
If the FDA approved a generic, why can’t I buy one?
FDA approval is permission to sell, not a launch. One company has held an approval since November 2025, but a patent, a settlement or a company’s own plans can hold a generic back until the expected month. See who is lined up
Will the generic cost less?
Usually, and more so as more companies sell one. 2 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 44% less once two companies sold a generic. See the price pattern
What should I do now?
Keep taking Vumerity 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.
Vumerity by the Numbers
- Reason
- Settlement between companiesThe brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- Moderate 2 companies have filed, 1 first in line
- Brand sales
- $1.1B a yearBlockbuster
- FDA approved 2019 October 2019 FDA Orange Book
- Patents listed 3 last runs to October 2033 FDA Orange Book
- Generics FDA-approved 1 company, approved November 2025 FDA Orange Book
- Medicare Part D spent $365.7M in 2025, for 4,514 people CMS Part D Spending by Drug
- Medicaid prescriptions 6,669 in the last four reported quarters, $65.7M CMS Medicaid drug utilization, to Q1 2026
Vumerity’s Road to a Generic
Vumerity has had the market to itself since the FDA approved it in October 2019 (Biogen Inc). Its 3 listed patents run to October 2033. Generic companies have challenged its patents with the FDA since December 2020.
The first generic of Vumerity is expected sometime in 2033.
Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
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.
Vumerity Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Vumerity’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.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 9,090,558 | A way of using it (U-1384) | September 2033 | Active |
| 10,080,733 | The active ingredient; the product’s formulation; a way of using it (U-1384) | September 2033 | Active |
| 8,669,281 | The active ingredient; the product’s formulation | October 2033 | Active |
Source: FDA Orange Book, application 211855. Patent numbers open the patent on Google Patents.
Patent Challenges to Vumerity
The first patent challenge to Vumerity reached the FDA in December 2020, from one company on that first day. The FDA has not approved a first challenger’s generic yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Vumerity’s patents run out can tell the FDA that a patent is invalid, or that its version does not infringe it. The FDA calls this a “Paragraph IV certification.” The brand company usually sues, and the FDA then generally cannot approve that generic for up to 30 months while the case runs. To reward going first, the companies that challenge first can get a 180-day head start: the FDA cannot approve the generics that came after them until it ends.
| Product | First challenged | Companies that day | 180-day head start | First challenger’s generic | Challenged patents run to | |
|---|---|---|---|---|---|---|
| Approved | On sale | |||||
| Delayed-release capsules, 231 mg | December 2020 | 1 company | Head start no longer applies decided November 2025 | Not yet | Not yet | September 2033 |
Source: the FDA’s Paragraph IV Patent Certifications list, as of September 2026. The FDA began posting the 180-day decisions and the first challenger’s approval and first sale in June 2019: an older entry it has not updated since reads “Not posted”, and “Not yet” means the list records no such event. “Companies that day” is the FDA’s count of challenges that arrived on the first day.
Who Is Lined Up to Make Generic Diroximel 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
2 companies have applied to the FDA to make generic diroximel fumarate.
The FDA keeps the other applications private until it acts on them, so those companies are not named here.
First in line. One of them was first in line: the first company to challenge the brand’s patents can earn 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Vumerity’s patents with the FDA since December 2020: see the patent challenges.
Approved by the FDA
The FDA has approved generic versions from 1 company, the first in November 2025. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
For Sale in Pharmacies
Not yet. No company lists a generic diroximel fumarate for sale with the FDA.
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Zydus Worldwide Dmcc | November 2025 | 231MG | AB |
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).
Vumerity 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 Vumerity, 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 Vumerity
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 Vumerity, before manufacturer rebates.
- $77.7M
- January to March 2026, the latest CMS has posted
For 3,356 people, about $10,483 per prescription fill - $365.7M
- 2025, the whole year
For 4,514 people, about $10,140 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $77,670,870 | 3,356 | $10,483.31 |
| 2025 | $365,737,525 | 4,514 | $10,140.22 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Vumerity only, so no generic is counted in it. What CMS says it is used for: Diroximel fumarate is used to treat multiple sclerosis (MS). It is not a cure for MS.
Medicaid Prescriptions by Quarter
6,669 prescriptions in the four quarters to Q1 2026, $65.7M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 1,463 | $15,000,786 |
| Q4 2025 | 1,731 | $16,777,963 |
| Q3 2025 | 1,812 | $17,877,638 |
| Q2 2025 | 1,663 | $16,029,984 |
| Q1 2025 | 1,713 | $16,265,321 |
Source: CMS Medicaid State Drug Utilization Data, over Vumerity’s own package codes.
Vumerity Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 231MG | Capsule, delayed release | Oral | October 2019 | Prescription reference product |
Source: FDA Orange Book, Biogen Inc. Listed for sale today by Biogen Inc. (FDA NDC Directory).
Vumerity NDC Codes and Packages
Each Vumerity 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 |
|---|---|---|---|
| 64406-0020-01 | DIROXIMEL FUMARATE 231 mg/1 capsule | bottle of 106 capsules | Biogen Inc. |
| 64406-0020-03 | DIROXIMEL FUMARATE 231 mg/1 capsule | bottle of 120 capsules | Biogen Inc. |
| 64406-0020-03 | DIROXIMEL FUMARATE 231 mg/1 capsule | bottle of 120 capsules | Biogen Inc. |
| 64406-0020-05 | DIROXIMEL FUMARATE 231 mg/1 capsule | bottle of 106 capsules | Biogen Inc. |
| 64406-0020-07 | DIROXIMEL FUMARATE 231 mg/1 capsule | bottle of 14 capsules | Biogen Inc. |
| 64406-0020-07 | DIROXIMEL FUMARATE 231 mg/1 capsule | bottle of 14 capsules | Biogen Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Vumerity’s own FDA approval (NDA 211855) are listed, never a generic. Some codes belong to companies that repackage Vumerity: it is the same medicine in a different package.
What a Generic Vumerity Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Vumerity 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 Vumerity”. 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 Vumerity
Is there a generic for Vumerity right now?
No. As of October 9, 2026 no generic diroximel fumarate is listed for sale in the FDA NDC Directory. 1 generic version is FDA-approved (Orange Book), which usually means it is waiting on patents or on the maker’s own launch plans.
When will Vumerity go generic?
Sometime in 2033 is the expected window, and that is probable but not certain. The brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
Will generic diroximel fumarate be the same as Vumerity?
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. 2 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 44% less once two companies sold a generic. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Vumerity?
Yes. The FDA Orange Book lists approved generic versions from 1 company, the first approved in November 2025: Zydus Worldwide Dmcc. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
When does the Vumerity patent expire?
The FDA Orange Book lists 3 patents for Vumerity; the last runs to October 2033. 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 window on this page (Sometime in 2033) weighs all of that.
Has anyone challenged the Vumerity patents?
Yes. The first patent challenge to Vumerity reached the FDA in December 2020, from one company on that first day. The FDA has not approved a first challenger’s generic yet. A patent challenge (a “Paragraph IV certification”) is a generic company telling the FDA that a patent listed for the brand is invalid or will not be infringed by its version. The first companies to file one can earn a 180-day head start, during which the FDA cannot approve the generics that filed after them.
Changes to This Projection
- First generic expected Sometime in 2033 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
- GocovriAmantadine HydrochlorideMarch 2030
- Quillichew ERMethylphenidate Hydrochloride2031 to 2032
- ZilrettaTriamcinolone AcetonideAugust 2031
- CinvantiAprepitantJune 2032
- MayzentSiponimod2033 to 2034
- TruseltiqInfigratinib PhosphateOctober 2033
About Vumerity
- Generic name diroximel fumarate
- How it is taken By mouth
- Company Biogen Inc
- Patent challenges Since December 2020 (FDA)
- More drugs Brand-name drugs starting with V
- Have a question? A pharmacist answers, free. Ask about Vumerity
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, FDA Paragraph IV Patent Certifications list, 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.