Bysanti Generic: When Will Generic Milsaperidone 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
Bysanti Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2036 to 2037 A wide window Why then?
- Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
- When does the brand’s protection end? May 2044 The last of 10 listed patents Why sooner?
- Can you buy a generic today? Not yet No company lists one for sale
Dr. Brian Staiger Explains
PharmD, BCPS · Clinical pharmacistGeneric milsaperidone is expected to be available between 2036 and 2037. None is for sale yet.
Why 2036 to 2037?
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 Bysanti’s protection runs to May 2044, how can a generic come sooner?
The patent that runs to May 2044 (12,478,619) 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, the companies are expected to settle on a date. 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. 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 Bysanti 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.
Bysanti 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
- None filed yet No filers on record
- Brand sales
- Sales not reported
- FDA approved 2026 February 2026 FDA Orange Book
- Patents listed 10 last runs to May 2044 FDA Orange Book
Bysanti’s Road to a Generic
Bysanti has had the market to itself since the FDA approved it in February 2026 (Vanda Pharmaceuticals Inc). Its FDA protection (new chemical entity) runs to February 2031. Its 10 listed patents run to May 2044.
The first generic of Bysanti is expected between 2036 and 2037.
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 May 2044
The last listed patent runs to May 2044, 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.
Bysanti Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Bysanti’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 |
|---|---|---|---|
| 10,570,453 | A way of using it (U-4436, U-4437) | March 2028 | Active |
| 9,157,121 | A way of using it (U-4436, U-4437) | April 2030 | Active |
| 10,563,259 | A way of using it (U-4437, U-4436) | July 2030 | Active |
| 12,606,869 | A way of using it (U-4506, U-4507) | September 2030 | Active |
| 8,999,638 | A way of using it (U-4436, U-4437) | October 2030 | Active |
| 9,074,255 | A way of using it (U-4436, U-4437) | December 2030 | Active |
| 9,072,742 | A way of using it (U-4436, U-4437) | January 2031 | Active |
| 9,074,256 | A way of using it (U-4436, U-4437) | February 2031 | Active |
| 9,074,254 | A way of using it (U-4436, U-4437) | December 2031 | Active |
| 12,478,619 | A way of using it (U-4434, U-4435) | May 2044 | 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. | February 2031 | Active |
Source: FDA Orange Book, application 220358. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Milsaperidone
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 Bysanti yet.
Approved by the FDA
Not yet. The FDA has not approved a generic milsaperidone. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic milsaperidone 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).
Bysanti 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 Bysanti, 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.
Bysanti Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 10MG | Tablet | Oral | February 2026 | Prescription reference product |
| 12MG | Tablet | Oral | February 2026 | Prescription reference product |
| 1MG | Tablet | Oral | February 2026 | Prescription reference product |
| 2MG | Tablet | Oral | February 2026 | Prescription reference product |
| 4MG | Tablet | Oral | February 2026 | Prescription reference product |
| 6MG | Tablet | Oral | February 2026 | Prescription reference product |
| 8MG | Tablet | Oral | February 2026 | Prescription reference product |
Source: FDA Orange Book, Vanda Pharmaceuticals Inc. Listed for sale today by Vanda Pharmaceuticals Inc. (FDA NDC Directory).
Bysanti NDC Codes and Packages
Each Bysanti 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 |
|---|---|---|---|
| 43068-0701-02 | MILSAPERIDONE 1 mg/1 tablet | bottle of 60 tablets | Vanda Pharmaceuticals Inc. |
| 43068-0908-14 | MILSAPERIDONE 1 mg/1 tablet | bottle of 14 tablets | Vanda Pharmaceuticals Inc. |
| 43068-0710-02 | MILSAPERIDONE 10 mg/1 tablet | bottle of 60 tablets | Vanda Pharmaceuticals Inc. |
| 43068-0712-02 | MILSAPERIDONE 12 mg/1 tablet | bottle of 60 tablets | Vanda Pharmaceuticals Inc. |
| 43068-0702-02 | MILSAPERIDONE 2 mg/1 tablet | bottle of 60 tablets | Vanda Pharmaceuticals Inc. |
| 43068-0704-02 | MILSAPERIDONE 4 mg/1 tablet | bottle of 60 tablets | Vanda Pharmaceuticals Inc. |
| 43068-0706-02 | MILSAPERIDONE 6 mg/1 tablet | bottle of 60 tablets | Vanda Pharmaceuticals Inc. |
| 43068-0910-14 | MILSAPERIDONE 6 mg/1 tablet | bottle of 14 tablets | Vanda Pharmaceuticals Inc. |
Show the other 8 Bysanti packages
| NDC | Product | Package | Company |
|---|---|---|---|
| 43068-0708-02 | MILSAPERIDONE 8 mg/1 tablet | bottle of 60 tablets | Vanda Pharmaceuticals Inc. |
| 43068-0911-14 | MILSAPERIDONE 8 mg/1 tablet | bottle of 14 tablets | Vanda Pharmaceuticals Inc. |
| 43068-0713-04 | kit | blister pack of 2 cartons of 1 kit | Vanda Pharmaceuticals Inc. |
| 43068-0714-04 | kit | blister pack of 4 cartons of 1 kit | Vanda Pharmaceuticals Inc. |
| 43068-0715-03 | kit | blister pack of 6 cartons of 1 kit | Vanda Pharmaceuticals Inc. |
| 43068-0912-08 | kit | blister pack of 2 cartons of 1 kit | Vanda Pharmaceuticals Inc. |
| 43068-0913-12 | kit | blister pack of 4 cartons of 1 kit | Vanda Pharmaceuticals Inc. |
| 43068-0914-08 | kit | blister pack of 6 cartons of 1 kit | Vanda Pharmaceuticals Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Bysanti’s own FDA approval (NDA 220358) are listed, never a generic. Some codes belong to companies that repackage Bysanti: it is the same medicine in a different package.
What a Generic Bysanti Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Bysanti 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 Bysanti”. 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 Bysanti
Is there a generic for Bysanti right now?
No. As of October 9, 2026 no generic milsaperidone is listed for sale in the FDA NDC Directory.
When will Bysanti go generic?
2036 to 2037 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 May 2044, but it covers a way of using it, not the medicine itself, which a generic can often work around or challenge.
Will generic milsaperidone be the same as Bysanti?
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 Bysanti?
Not yet. The FDA Orange Book lists no approved generic version of Bysanti.
When does the Bysanti patent expire?
The FDA Orange Book lists 10 patents for Bysanti; the last runs to May 2044. 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 (2036 to 2037) weighs all of that.
Changes to This Projection
- First generic expected 2036 to 2037 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
- SirturoBedaquiline FumarateMarch 2029
- VocabriaCabotegravir SodiumFebruary 2031
- DuzalloAllopurinol and LesinuradFebruary 2032
- IzervayAvacincaptad Pegol Sodium2033 to 2035
- OlinvykOliceridineOctober 2034
- AnnoveraEthinyl Estradiol and Segesterone AcetateJune 2039
About Bysanti
- Generic name milsaperidone
- How it is taken By mouth
- Company Vanda Pharmaceuticals Inc
- More drugs Brand-name drugs starting with B
- Have a question? A pharmacist answers, free. Ask about Bysanti
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, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.