Barhemsys Generic: When Will Generic Amisulpride 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
Barhemsys Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? February 2038 About 11.5 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 2038 8 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic amisulpride is expected to be available in February 2038, about 11.5 years away. None is for sale yet.
Why February 2038?
It is when Barhemsys’s patents 11,357,753, 12,005,042 and 12,329,740 end. They cover 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 Barhemsys 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.
Barhemsys 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
- $8M a yearSmaller seller
- FDA approved 2020 February 2020 FDA Orange Book
- Patents listed 8 last runs to February 2038 FDA Orange Book
- Medicaid prescriptions 116 in the last four reported quarters, $17.3K CMS Medicaid drug utilization, to Q1 2026
Barhemsys’s Road to a Generic
Barhemsys has had the market to itself since the FDA approved it in February 2020 (Lxo Ireland Designated Activity Co). Its 8 listed patents run to February 2038.
The first generic of Barhemsys is expected in February 2038.
Why that month: patents 11,357,753, 12,005,042 and 12,329,740, on 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.
Barhemsys Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Barhemsys’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 11,357,753, 12,005,042 and 12,329,740, which end in February 2038, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 9,545,426 | A way of using it (U-1744, U-2754) | March 2031 | Active |
| 9,889,118 | A way of using it (U-2754, U-1744) | March 2031 | Active |
| 10,525,033 | The product’s formulation | March 2031 | Active |
| 12,194,022 | A way of using it (U-1744, U-3467) | March 2031 | Active |
| 9,084,765 | A way of using it (U-1744, U-2754, U-3467) | February 2034 | Active |
| 11,357,753 Sets the expected month of generic availability | A way of using it (U-2754) | February 2038 | Active |
| 12,005,042 Sets the expected month of generic availability | A way of using it (U-1744, U-3467, U-2754) | February 2038 | Active |
| 12,329,740 Sets the expected month of generic availability | A way of using it (U-2754, U-3467) | February 2038 | Active |
Source: FDA Orange Book, application 209510. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Amisulpride
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 Barhemsys yet.
Approved by the FDA
Not yet. The FDA has not approved a generic amisulpride. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic amisulpride 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).
Barhemsys 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 Barhemsys, 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 Barhemsys
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
116 prescriptions in the four quarters to Q1 2026, $17.3K paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 51 | $202 |
| Q4 2025 | 15 | $156 |
| Q3 2025 | 25 | $0 |
| Q2 2025 | 25 | $16,934 |
| Q1 2025 | 15 | $8,263 |
Source: CMS Medicaid State Drug Utilization Data, over Barhemsys’s own package codes.
Barhemsys Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 5MG/2ML (2.5MG/ML) | Solution | Intravenous | February 2020 | Prescription reference product |
| 10MG/4ML (2.5MG/ML) | Solution | Intravenous | September 2020 | Prescription reference product |
Source: FDA Orange Book, Lxo Ireland Designated Activity Co. Listed for sale today by Acacia Pharma Ltd (FDA NDC Directory).
Barhemsys NDC Codes and Packages
Each Barhemsys 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 |
|---|---|---|---|
| 71390-0125-20 | AMISULPRIDE 2.5 mg/mL injection, solution | package of 10 cartons of 1 vial of 2 mL | Acacia Pharma Ltd |
| 71390-0125-20 | AMISULPRIDE 2.5 mg/mL injection, solution | package of 10 cartons of 1 vial of 2 mL | Acacia Pharma Ltd |
| 71390-0125-50 | AMISULPRIDE 2.5 mg/mL injection, solution | package of 10 cartons of 1 vial of 4 mL | Acacia Pharma Ltd |
| 71390-0125-50 | AMISULPRIDE 2.5 mg/mL injection, solution | package of 10 cartons of 1 vial of 4 mL | Acacia Pharma Ltd |
Source: the FDA NDC Directory, current listings only. Only packages sold under Barhemsys’s own FDA approval (NDA 209510) are listed, never a generic. Some codes belong to companies that repackage Barhemsys: it is the same medicine in a different package.
What a Generic Barhemsys Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Barhemsys 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 Barhemsys”. 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 Barhemsys
Is there a generic for Barhemsys right now?
No. As of October 9, 2026 no generic amisulpride is listed for sale in the FDA NDC Directory.
When will Barhemsys go generic?
February 2038 is the expected month, and that is toss-up but not certain. It is when Barhemsys’s patents 11,357,753, 12,005,042 and 12,329,740 end. They cover a way of using it, and once they end, generics can go on sale as soon as the FDA approves them.
Will generic amisulpride be the same as Barhemsys?
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 Barhemsys?
Not yet. The FDA Orange Book lists no approved generic version of Barhemsys.
When does the Barhemsys patent expire?
The FDA Orange Book lists 8 patents for Barhemsys; the last runs to February 2038. The one behind the expected month is patents 11,357,753, 12,005,042 and 12,329,740, which end in February 2038. 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 2038) weighs all of that.
Changes to This Projection
- First generic expected February 2038 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
- VanflytaQuizartinib HydrochlorideSeptember 2033
- Abilify MyCiteAripiprazoleOctober 2033
- IlluccixGallium Ga-68 GozetotideJuly 2035
- CysviewHexaminolevulinate HydrochlorideJanuary 2038
- RezzayoRezafunginJuly 2038
- NereusTradipitantApril 2039
About Barhemsys
- Generic name amisulpride
- How it is taken Into a vein (IV)
- Company Lxo Ireland Designated Activity Co
- More drugs Brand-name drugs starting with B
- Have a question? A pharmacist answers, free. Ask about Barhemsys
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, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.