Qelbree Generic: When Will Generic Viloxazine 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
Qelbree Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2031 to 2032 A wide window Why then?
- Has the FDA approved a generic? Not yet 1 company holds a tentative approval Why not yet?
- When does the last patent end? April 2035 6 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Not yet No company lists one for sale
Generic viloxazine hydrochloride is expected to be available between 2031 and 2032. None is for sale yet.
Why 2031 to 2032?
The patent fight is likely to end in an agreement that sets the launch. The terms are not public yet. We rate it probable: more likely than not, but it can still move.
If Qelbree’s last patent runs to April 2035, how can a generic come sooner?
The 3 patents that run past the expected month, to April 2035 (9,358,204, 9,603,853 and 9,662,338), cover the product’s formulation and a way of using it. A patent like that protects one way of making or using the medicine, not the medicine itself. A generic company can often make its version a different way or leave that use off its label, or a court can rule the patent invalid or not infringed. Here, the companies are expected to settle on a date. Generic companies have been challenging Qelbree’s patents with the FDA since April 2025. That is why the expected month comes before the last protection ends. See the road to a generic
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. One company already holds a “tentative” approval, the FDA’s word for a generic that is ready but still blocked: Appco Pharma LLC (April 2026). See who is lined up
Will the generic cost less?
Usually, and more so as more companies sell one. 9 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid over 95% less once six or more companies sold a generic, which would take the $12.73 pharmacies pay per capsule for Qelbree today to under $0.64. See the price estimate
What should I do now?
Keep taking Qelbree 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.
Qelbree by the Numbers
- Reason
- Settlement expectedThe patent fight is likely to end in an agreement that sets the launch. The terms are not public yet.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- Very strong 9 companies have filed, 7 first in line
- Brand sales
- $545M a yearBig seller
- FDA approved 2021 April 2021 FDA Orange Book
- Patents listed 6 last runs to April 2035 A generic is expected sooner, between 2031 and 2032. See why FDA Orange Book
- Pharmacies pay $12.73 per capsule, up 12.2% in a year NADAC, October 2026
- Medicare Part D spent $9.9M in 2025, for 4,019 people CMS Part D Spending by Drug
- Medicaid prescriptions 471.1K in the last four reported quarters, $240.8M CMS Medicaid drug utilization, to Q1 2026
Qelbree’s Road to a Generic
Qelbree has had the market to itself since the FDA approved it in April 2021 (Supernus Pharmaceuticals Inc). Its FDA protections on record ended by April 2026. Its 6 listed patents run to April 2035. Generic companies have challenged its patents with the FDA since April 2025.
The first generic of Qelbree is expected between 2031 and 2032.
Why that month: the patent fight is likely to end in an agreement that sets the launch. The terms are not public yet.
Why a Generic Can Come Before April 2035
The last listed patent runs to April 2035, but it covers the product’s formulation and a way of using it, not the medicine itself, which a generic can often work around or challenge. Dr. Brian explains
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.
Qelbree Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Qelbree’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 |
|---|---|---|---|
| 11,324,753 | A way of using it (U-727) | September 2029 | Active |
| 11,458,143 | A way of using it (U-727) | September 2029 | Active |
| 12,121,523 | A way of using it (U-727) | September 2029 | Active |
| 9,358,204 | The product’s formulation | February 2033 | Active |
| 9,603,853 | A way of using it (U-727) | February 2033 | Active |
| 9,662,338 | The product’s formulation | April 2035 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New chemical entity NCE | Five years of protection for a medicine whose active ingredient the FDA had never approved before. | April 2026 | Ended |
Source: FDA Orange Book, application 211964. Patent numbers open the patent on Google Patents.
Patent Challenges to Qelbree
The first patent challenge to Qelbree reached the FDA in April 2025, from 7 companies on that first day. The FDA’s list has 3 entries for Qelbree, by form and strength. 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 Qelbree’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 | |||||
| Extended-release capsules, 100 mg | April 2025 | 7 companies | No decision yet | Not yet | Not yet | April 2035 |
| Extended-release capsules, 150 mg | April 2025 | 7 companies | No decision yet | Not yet | Not yet | April 2035 |
| Extended-release capsules, 200 mg | April 2025 | 8 companies | No decision yet | Not yet | Not yet | April 2035 |
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 Viloxazine Hydrochloride
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
9 companies have applied to the FDA to make generic viloxazine hydrochloride.
The FDA has tentatively approved one company’s generic: Appco Pharma LLC (April 2026). A tentative approval means the generic is ready, but a patent or exclusivity still stops the FDA from giving it final approval.
The FDA keeps the other applications private until it acts on them, so those companies are not named here.
First in line. 7 of them were first in line, all filing on the first day any company did: they can share 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Qelbree’s patents with the FDA since April 2025: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic viloxazine hydrochloride. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic viloxazine hydrochloride 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).
Qelbree Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Qelbree ER 100 mg capsule
$12.73 per capsule in October 2026, up 12.2% from a year earlier.
Hover over or tap anywhere on the chart to see that month’s price.
- Qelbree ER 100 mg capsule $12.73 per capsule
- Qelbree ER 150 mg capsule $12.73 per capsule
- Qelbree ER 200 mg capsule $12.74 per capsule
See the numbers
| Month | Pharmacies paid per capsule |
|---|---|
| October 2026 | $12.73 |
| September 2026 | $12.73 |
| August 2026 | $12.73 |
| July 2026 | $12.73 |
| June 2026 | $12.75 |
| May 2026 | $12.75 |
| April 2026 | $12.74 |
| March 2026 | $12.74 |
| February 2026 | $12.74 |
| January 2026 | $12.74 |
| February 2024 | $11.35 |
| January 2024 | $11.35 |
NADAC: the national average price retail pharmacies pay to buy the medicine (CMS survey, updated weekly), the last price of each month for one package. It is not what you pay: that depends on your insurance or discount card.
What a Generic Could Cost
How we estimate it. We start from what pharmacies pay for Qelbree today: $12.73 per capsule for Qelbree ER 100 mg capsule in October 2026, from the national NADAC survey. Then we apply the FDA’s finding of how far that price 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). Qelbree has 9 companies lined up, so our estimate uses the figure for six or more companies. More companies would bring the price lower; fewer, less of a drop.
Dollar figures apply FDA’s median drops to the $12.73 pharmacies pay per capsule today. An estimate from the pattern, not a price quote: what you pay depends on your insurance or discount card.
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 Qelbree
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 Qelbree, before manufacturer rebates.
- $2.9M
- January to March 2026, the latest CMS has posted
For 2,267 people, about $643 per prescription fill - $9.9M
- 2025, the whole year
For 4,019 people, about $612 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $2,925,933 | 2,267 | $643.34 |
| 2025 | $9,948,583 | 4,019 | $612.26 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Qelbree only, so no generic is counted in it. What CMS says it is used for: Viloxazine is used to treat attention-deficit hyperactivity disorder (ADHD) as part of a total treatment plan, including psychological, social, and other treatments. It may help to increase the ability to pay attention, concentrate, stay focused, and stop fidgeting.
Medicaid Prescriptions by Quarter
471,064 prescriptions in the four quarters to Q1 2026, $240.8M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 117,981 | $62,934,012 |
| Q4 2025 | 124,714 | $62,859,726 |
| Q3 2025 | 116,376 | $58,730,861 |
| Q2 2025 | 111,993 | $56,228,094 |
| Q1 2025 | 107,262 | $53,037,181 |
Source: CMS Medicaid State Drug Utilization Data, over Qelbree’s own package codes.
Qelbree Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 100MG BASE | Capsule, extended release | Oral | April 2021 | Prescription reference product |
| EQ 150MG BASE | Capsule, extended release | Oral | April 2021 | Prescription reference product |
| EQ 200MG BASE | Capsule, extended release | Oral | April 2021 | Prescription reference product |
Source: FDA Orange Book, Supernus Pharmaceuticals Inc. Listed for sale today by Supernus Pharmaceuticals, Inc (FDA NDC Directory).
Qelbree NDC Codes and Packages
Each Qelbree 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 |
|---|---|---|---|
| 17772-0131-01 | VILOXAZINE HYDROCHLORIDE 100 mg/1 capsule, extended release | bottle of 100 capsules | Supernus Pharmaceuticals, Inc |
| 17772-0131-01 | VILOXAZINE HYDROCHLORIDE 100 mg/1 capsule, extended release | bottle of 100 capsules | Supernus Pharmaceuticals, Inc |
| 17772-0131-07 | VILOXAZINE HYDROCHLORIDE 100 mg/1 capsule, extended release | bottle of 7 capsules | Supernus Pharmaceuticals, Inc |
| 17772-0131-07 | VILOXAZINE HYDROCHLORIDE 100 mg/1 capsule, extended release | bottle of 7 capsules | Supernus Pharmaceuticals, Inc |
| 17772-0131-30 | VILOXAZINE HYDROCHLORIDE 100 mg/1 capsule, extended release | bottle of 30 capsules | Supernus Pharmaceuticals, Inc |
| 17772-0131-30 | VILOXAZINE HYDROCHLORIDE 100 mg/1 capsule, extended release | bottle of 30 capsules | Supernus Pharmaceuticals, Inc |
| 17772-0131-60 | VILOXAZINE HYDROCHLORIDE 100 mg/1 capsule, extended release | bottle of 60 capsules | Supernus Pharmaceuticals, Inc |
| 17772-0131-60 | VILOXAZINE HYDROCHLORIDE 100 mg/1 capsule, extended release | bottle of 60 capsules | Supernus Pharmaceuticals, Inc |
Show the other 22 Qelbree packages
| NDC | Product | Package | Company |
|---|---|---|---|
| 17772-0131-90 | VILOXAZINE HYDROCHLORIDE 100 mg/1 capsule, extended release | bottle of 90 capsules | Supernus Pharmaceuticals, Inc |
| 17772-0131-90 | VILOXAZINE HYDROCHLORIDE 100 mg/1 capsule, extended release | bottle of 90 capsules | Supernus Pharmaceuticals, Inc |
| 17772-0132-01 | VILOXAZINE HYDROCHLORIDE 150 mg/1 capsule, extended release | bottle of 100 capsules | Supernus Pharmaceuticals, Inc |
| 17772-0132-01 | VILOXAZINE HYDROCHLORIDE 150 mg/1 capsule, extended release | bottle of 100 capsules | Supernus Pharmaceuticals, Inc |
| 17772-0132-07 | VILOXAZINE HYDROCHLORIDE 150 mg/1 capsule, extended release | bottle of 7 capsules | Supernus Pharmaceuticals, Inc |
| 17772-0132-07 | VILOXAZINE HYDROCHLORIDE 150 mg/1 capsule, extended release | bottle of 7 capsules | Supernus Pharmaceuticals, Inc |
| 17772-0132-30 | VILOXAZINE HYDROCHLORIDE 150 mg/1 capsule, extended release | bottle of 30 capsules | Supernus Pharmaceuticals, Inc |
| 17772-0132-30 | VILOXAZINE HYDROCHLORIDE 150 mg/1 capsule, extended release | bottle of 30 capsules | Supernus Pharmaceuticals, Inc |
| 17772-0132-60 | VILOXAZINE HYDROCHLORIDE 150 mg/1 capsule, extended release | bottle of 60 capsules | Supernus Pharmaceuticals, Inc |
| 17772-0132-60 | VILOXAZINE HYDROCHLORIDE 150 mg/1 capsule, extended release | bottle of 60 capsules | Supernus Pharmaceuticals, Inc |
| 17772-0132-90 | VILOXAZINE HYDROCHLORIDE 150 mg/1 capsule, extended release | bottle of 90 capsules | Supernus Pharmaceuticals, Inc |
| 17772-0132-90 | VILOXAZINE HYDROCHLORIDE 150 mg/1 capsule, extended release | bottle of 90 capsules | Supernus Pharmaceuticals, Inc |
| 17772-0133-01 | VILOXAZINE HYDROCHLORIDE 200 mg/1 capsule, extended release | bottle of 100 capsules | Supernus Pharmaceuticals, Inc |
| 17772-0133-01 | VILOXAZINE HYDROCHLORIDE 200 mg/1 capsule, extended release | bottle of 100 capsules | Supernus Pharmaceuticals, Inc |
| 17772-0133-07 | VILOXAZINE HYDROCHLORIDE 200 mg/1 capsule, extended release | bottle of 7 capsules | Supernus Pharmaceuticals, Inc |
| 17772-0133-07 | VILOXAZINE HYDROCHLORIDE 200 mg/1 capsule, extended release | bottle of 7 capsules | Supernus Pharmaceuticals, Inc |
| 17772-0133-30 | VILOXAZINE HYDROCHLORIDE 200 mg/1 capsule, extended release | bottle of 30 capsules | Supernus Pharmaceuticals, Inc |
| 17772-0133-30 | VILOXAZINE HYDROCHLORIDE 200 mg/1 capsule, extended release | bottle of 30 capsules | Supernus Pharmaceuticals, Inc |
| 17772-0133-60 | VILOXAZINE HYDROCHLORIDE 200 mg/1 capsule, extended release | bottle of 60 capsules | Supernus Pharmaceuticals, Inc |
| 17772-0133-60 | VILOXAZINE HYDROCHLORIDE 200 mg/1 capsule, extended release | bottle of 60 capsules | Supernus Pharmaceuticals, Inc |
| 17772-0133-90 | VILOXAZINE HYDROCHLORIDE 200 mg/1 capsule, extended release | bottle of 90 capsules | Supernus Pharmaceuticals, Inc |
| 17772-0133-90 | VILOXAZINE HYDROCHLORIDE 200 mg/1 capsule, extended release | bottle of 90 capsules | Supernus Pharmaceuticals, Inc |
Source: the FDA NDC Directory, current listings only. Only packages sold under Qelbree’s own FDA approval (NDA 211964) are listed, never a generic. Some codes belong to companies that repackage Qelbree: it is the same medicine in a different package.
What a Generic Qelbree Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Qelbree 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 Qelbree”. 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 Qelbree
Is there a generic for Qelbree right now?
No. As of October 9, 2026 no generic viloxazine hydrochloride is listed for sale in the FDA NDC Directory.
When will Qelbree go generic?
2031 to 2032 is the expected window, and that is probable but not certain. The patent fight is likely to end in an agreement that sets the launch. The terms are not public yet. The last listed patent runs to April 2035, but it covers the product’s formulation and a way of using it, not the medicine itself, which a generic can often work around or challenge.
Will generic viloxazine hydrochloride be the same as Qelbree?
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. 9 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid over 95% less once six or more companies sold a generic, which would take the $12.73 pharmacies pay per capsule for Qelbree today to under $0.64. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Qelbree?
Not yet. The FDA Orange Book lists no approved generic version of Qelbree.
When does the Qelbree patent expire?
The FDA Orange Book lists 6 patents for Qelbree; the last runs to April 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 window on this page (2031 to 2032) weighs all of that.
Has anyone challenged the Qelbree patents?
Yes. The first patent challenge to Qelbree reached the FDA in April 2025, from 7 companies 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.
How much does Qelbree cost now?
Pharmacies paid about $12.73 per capsule for Qelbree ER 100 mg capsule in October 2026, by the national survey of what pharmacies pay (NADAC). That is the pharmacy’s cost, not your price: what you pay depends on your insurance or discount card.
Changes to This Projection
- First generic expected 2031 to 2032 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
- JentaduetoLinagliptin and Metformin HydrochlorideJuly to December 2026
- OngentysOpicaponeDecember 2032
- VyleesiBremelanotide AcetateNovember 2033
- ElyxybCelecoxibMay 2036
- ArtesunateArtesunateFebruary 2044
- Sotalol Hydrochloride IVSotalol HydrochlorideTBD no date yet
About Qelbree
- Generic name viloxazine hydrochloride
- How it is taken By mouth
- Company Supernus Pharmaceuticals Inc
- Patent challenges Since April 2025 (FDA)
- More drugs Brand-name drugs starting with Q
- Have a question? A pharmacist answers, free. Ask about Qelbree
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, NADAC (CMS), 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.