Byvalson Generic: When Will Generic Nebivolol and Valsartan 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
Byvalson Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? During 2026 Sometime that year Why then?
- Has the FDA approved a generic? September 2022 1 company approved Why not on sale?
- When does the last patent end? October 2027 2 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 nebivolol and valsartan is expected to be available sometime in 2026. None is for sale yet.
Why 2026?
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 Byvalson’s last patent runs to October 2027, how can a generic come sooner?
The patent that runs to October 2027 (7,838,552) covers 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, a settlement between the companies sets the date. Generic companies have been challenging Byvalson’s patents with the FDA since June 2017. That is why the expected month comes before the last protection ends. See the road to a generic
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 September 2022, 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. One company has applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 31% less once one company sold a generic. See the price pattern
What should I do now?
Keep taking Byvalson 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.
Byvalson 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
- Low 1 company has filed, 1 first in line
- Brand sales
- Sales not reported
- FDA approved 2016 June 2016 FDA Orange Book
- Patents listed 2 last runs to October 2027 A generic is expected sooner, sometime in 2026. See why FDA Orange Book
- Generics FDA-approved 1 company, approved September 2022 FDA Orange Book
Byvalson’s Road to a Generic
Byvalson has had the market to itself since the FDA approved it in June 2016 (Abbvie Inc). Its 2 listed patents run to October 2027 (1 already expired). Generic companies have challenged its patents with the FDA since June 2017.
The first generic of Byvalson is expected sometime in 2026.
Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
Why a Generic Can Come Before October 2027
The last listed patent runs to October 2027, but it covers 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.
Byvalson Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Byvalson’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 |
|---|---|---|---|
| 7,803,838 | The product’s formulation | August 2026 | Expired |
| 7,838,552 | A way of using it (U-185) | October 2027 | Active |
Source: FDA Orange Book, application 206302. Patent numbers open the patent on Google Patents.
Patent Challenges to Byvalson
The first patent challenge to Byvalson reached the FDA in June 2017, from one company on that first day. The FDA approved a first challenger’s generic in September 2022, and the list records no sale by a first challenger yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Byvalson’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 | |||||
| Tablets, 5 mg/80 mg | June 2017 | 1 company | Decision deferred decided October 2022 | September 2022 | Not yet | October 2027 |
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 Nebivolol and Valsartan
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
One company has applied to the FDA to make generic nebivolol and valsartan.
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 Byvalson’s patents with the FDA since June 2017: see the patent challenges.
Approved by the FDA
The FDA has approved generic versions from 1 company, the first in September 2022. 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 nebivolol and valsartan for sale with the FDA.
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Prinston Pharmaceutical Inc | September 2022 | EQ 5MG BASE;80MG | – |
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).
Byvalson 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 Byvalson, 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.
Byvalson Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 5MG BASE;80MG | Tablet | Oral | June 2016 | Discontinued reference product |
Source: FDA Orange Book, Abbvie Inc.
What a Generic Byvalson Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Byvalson 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 Byvalson”. 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 Byvalson
Is there a generic for Byvalson right now?
No. As of October 9, 2026 no generic nebivolol and valsartan 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 Byvalson go generic?
Sometime in 2026 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. The last listed patent runs to October 2027, but it covers a way of using it, not the medicine itself, which a generic can often work around or challenge.
Will generic nebivolol and valsartan be the same as Byvalson?
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. One company has applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 31% less once one company sold a generic. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Byvalson?
Yes. The FDA Orange Book lists approved generic versions from 1 company, the first approved in September 2022: Prinston Pharmaceutical Inc. 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 Byvalson patent expire?
The FDA Orange Book lists 2 patents for Byvalson; the last runs to October 2027. 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 2026) weighs all of that.
Has anyone challenged the Byvalson patents?
Yes. The first patent challenge to Byvalson reached the FDA in June 2017, from one company on that first day. The FDA approved a first challenger’s generic in September 2022, and the list records no sale by a first challenger 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 2026 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.
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- AnzupgoDelgocitinibSeptember 2036
- OlpruvaSodium PhenylbutyrateTBD no date yet
About Byvalson
- Generic name nebivolol and valsartan
- How it is taken By mouth
- Company Abbvie Inc
- Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
- Patent challenges Since June 2017 (FDA)
- More drugs Brand-name drugs starting with B
- Have a question? A pharmacist answers, free. Ask about Byvalson
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, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.