Byfavo Generic: When Will Generic Remimazolam 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
Byfavo Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? January 2034 About 7.5 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? January 2034 11 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic remimazolam is expected to be available in January 2034, about 7.5 years away. None is for sale yet.
Why January 2034?
It is when Byfavo’s patent 9,827,251 ends. That patent covers a way of using it, and once it ends, generics can go on sale as soon as the FDA approves them. We rate it probable: more likely than not, but it can still move.
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, 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 Byfavo 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.
Byfavo by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- 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 2020 October 2020 FDA Orange Book
- Patents listed 11 last runs to January 2034 FDA Orange Book
- Medicaid prescriptions 293 in the last four reported quarters, $23.1K CMS Medicaid drug utilization, to Q1 2026
Byfavo’s Road to a Generic
Byfavo has had the market to itself since the FDA approved it in October 2020 (Acacia Pharma Ltd). Its 11 listed patents run to January 2034. Generic companies have challenged its patents with the FDA since October 2024.
The first generic of Byfavo is expected in January 2034.
Why that month: patent 9,827,251, on a way of using it, ends 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.
Byfavo Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Byfavo’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: patent 9,827,251, which ends in January 2034, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 9,777,007 | The product’s formulation | July 2027 | Active |
| 9,914,738 | The product’s formulation | July 2027 | Active |
| 10,472,365 | A way of using it (U-2968) | July 2027 | Active |
| 10,961,250 | The product’s formulation; a way of using it (U-2968) | July 2027 | Active |
| 9,737,547 | A way of using it (U-2968) | November 2031 | Active |
| 10,052,334 | A way of using it (U-2968) | November 2031 | Active |
| 10,195,210 | A way of using it (U-2968) | November 2031 | Active |
| 10,342,800 | A way of using it (U-2968) | November 2031 | Active |
| 10,722,522 | A way of using it (U-2968) | November 2031 | Active |
| 9,561,236 | A way of using it (U-2968) | April 2033 | Active |
| 9,827,251 Sets the expected month of generic availability | A way of using it (U-2968) | January 2034 | Active |
Source: FDA Orange Book, application 212295. Patent numbers open the patent on Google Patents.
Patent Challenges to Byfavo
The first patent challenge to Byfavo reached the FDA in October 2024, 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 Byfavo’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 | |||||
| Powder for injection, 20 mg/vial | October 2024 | 1 company | No decision yet | Not yet | Not yet | January 2034 |
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 Remimazolam
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 remimazolam.
The FDA names a company only once it approves its application, even tentatively, and it has not done that for this one yet, so the company is not named here. Names often come out in the brand company’s patent lawsuits or in the companies’ own announcements.
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 Byfavo’s patents with the FDA since October 2024: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic remimazolam. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic remimazolam 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).
Byfavo 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 Byfavo, 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 Byfavo
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.
Medicaid Prescriptions by Quarter
293 prescriptions in the four quarters to Q1 2026, $23.1K paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 59 | $1,442 |
| Q4 2025 | 60 | $4,552 |
| Q3 2025 | 81 | $7,660 |
| Q2 2025 | 93 | $9,427 |
| Q1 2025 | 71 | $4,958 |
Source: CMS Medicaid State Drug Utilization Data, over Byfavo’s own package codes.
Byfavo Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 20MG BASE/VIAL | Powder | Intravenous | October 2020 | Prescription reference product |
Source: FDA Orange Book, Acacia Pharma Ltd. Listed for sale today by Acacia Pharma, Ltd. (FDA NDC Directory).
Byfavo NDC Codes and Packages
Each Byfavo 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 |
|---|---|---|---|
| 71390-0011-11 | REMIMAZOLAM BESYLATE 2.5 mg/mL injection, powder, lyophilized, for solution | carton of 10 vials of 8 mL | Acacia Pharma, Ltd. |
| 71390-0011-11 | REMIMAZOLAM BESYLATE 2.5 mg/mL injection, powder, lyophilized, for solution | carton of 10 vials of 8 mL | Acacia Pharma, Ltd. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Byfavo’s own FDA approval (NDA 212295) are listed, never a generic. Some codes belong to companies that repackage Byfavo: it is the same medicine in a different package.
What a Generic Byfavo Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Byfavo 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 Byfavo”. 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 Byfavo
Is there a generic for Byfavo right now?
No. As of October 9, 2026 no generic remimazolam is listed for sale in the FDA NDC Directory.
When will Byfavo go generic?
January 2034 is the expected month, and that is probable but not certain. It is when Byfavo’s patent 9,827,251 ends. That patent covers a way of using it, and once it ends, generics can go on sale as soon as the FDA approves them.
Will generic remimazolam be the same as Byfavo?
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 Byfavo?
Not yet. The FDA Orange Book lists no approved generic version of Byfavo.
When does the Byfavo patent expire?
The FDA Orange Book lists 11 patents for Byfavo; the last runs to January 2034. The one behind the expected month is patent 9,827,251, which ends in January 2034. 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 (January 2034) weighs all of that.
Has anyone challenged the Byfavo patents?
Yes. The first patent challenge to Byfavo reached the FDA in October 2024, 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 January 2034 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
- VizamylFlutemetamol F-18September 2029
- AmzeeqMinocycline HydrochlorideJuly 2031
- OjemdaTovorafenibAugust 2036
- DurystaBimatoprostDuring 2041
- IxempraIxabepiloneTBD no date yet
- SiklosHydroxyureaTBD no date yet
About Byfavo
- Generic name remimazolam
- How it is taken Into a vein (IV)
- Company Acacia Pharma Ltd
- Patent challenges Since October 2024 (FDA)
- More drugs Brand-name drugs starting with B
- Have a question? A pharmacist answers, free. Ask about Byfavo
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, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.