Risvan Generic: When Will Generic Risperidone 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
Risvan Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? May 2031 About 4.5 years away Why then?
- Has the FDA approved a generic? December 2023 3 companies approved
- When does the last patent end? May 2031 14 patents listed with the FDA
- Can you buy a generic today? Yes 1 company lists one
It already is. A generic risperidone is listed for sale by 1 company, so ask your pharmacy whether it can fill your prescription with one.
Why May 2031?
It is when Risvan’s patents 10,058,504, 10,085,936, 10,182,982, 10,195,138 and 10 more end. They cover the product’s formulation and a way of using it, and once they end, generics can go on sale as soon as the FDA approves them. It is too early to rate how firm that is.
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Risvan, but the active ingredient, strength and form are the same. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Risvan by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Not rated Too early to rate. The month is where the records point today.
- Price competition
- None filed yet No filers on record
- Brand sales
- Sales not reported
- FDA approved 2024 March 2024 FDA Orange Book
- Patents listed 14 last runs to May 2031 FDA Orange Book
- Generics FDA-approved 3 companies, the first approved December 2023 FDA Orange Book
Risvan’s Road to a Generic
Risvan has had the market to itself since the FDA approved it in March 2024 (Laboratorios Farmaceuticos Rovi SA). Its FDA protection (new product) runs to March 2027. Its 14 listed patents run to May 2031.
The first generic of Risvan is expected in May 2031.
Why that month: patents 10,058,504, 10,085,936, 10,182,982, 10,195,138 and 10 more, on the product’s formulation and 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.
Risvan Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Risvan’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 10,058,504, 10,085,936, 10,182,982, 10,195,138 and 10 more, which end in May 2031, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 10,058,504 Sets the expected month of generic availability | The product’s formulation | May 2031 | Active |
| 10,085,936 Sets the expected month of generic availability | The product’s formulation | May 2031 | Active |
| 10,182,982 Sets the expected month of generic availability | A way of using it (U-3943) | May 2031 | Active |
| 10,195,138 Sets the expected month of generic availability | A way of using it (U-3943) | May 2031 | Active |
| 10,335,366 Sets the expected month of generic availability | The product’s formulation | May 2031 | Active |
| 10,463,607 Sets the expected month of generic availability | The product’s formulation | May 2031 | Active |
| 10,881,605 Sets the expected month of generic availability | The product’s formulation | May 2031 | Active |
| 11,007,139 Sets the expected month of generic availability | A way of using it (U-3942) | May 2031 | Active |
| 11,173,110 Sets the expected month of generic availability | A way of using it (U-3941) | May 2031 | Active |
| 11,241,377 Sets the expected month of generic availability | A way of using it (U-3939) | May 2031 | Active |
| 11,752,092 Sets the expected month of generic availability | A way of using it (U-3941) | May 2031 | Active |
| 11,752,093 Sets the expected month of generic availability | The product’s formulation | May 2031 | Active |
| 11,752,094 Sets the expected month of generic availability | A way of using it (U-3942) | May 2031 | Active |
| 11,759,416 Sets the expected month of generic availability | A way of using it (U-3939) | May 2031 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New product NP | Three years of protection for a change that needed new clinical studies. | March 2027 | Active |
Source: FDA Orange Book, application 214835. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Risperidone
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 application count is on record for Risvan, but the FDA has already approved 3 companies (step 2), and every approval starts with an application.
Approved by the FDA
The FDA has approved generic versions from 3 companies, the first in December 2023. 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
Yes. A generic risperidone is listed for sale by 1 company. Ask your pharmacy whether it can fill your prescription with it.
Amneal Pharmaceuticals LLC
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Teva Pharmaceuticals USA Inc | December 2023 | 12.5MG/VIAL, 25MG/VIAL, 37.5MG/VIAL, 50MG/VIAL | AB |
| Amneal Eu Ltd | September 2025 | 12.5MG/VIAL, 25MG/VIAL, 37.5MG/VIAL, 50MG/VIAL | AB |
| Nanomi BV | September 2025 | 25MG/VIAL, 37.5MG/VIAL, 50MG/VIAL | AB |
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).
Risvan 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 Risvan, 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.
Risvan Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 100MG | For suspension, extended release | Intramuscular | March 2024 | Discontinued reference product |
| 75MG | For suspension, extended release | Intramuscular | March 2024 | Discontinued reference product |
Source: FDA Orange Book, Laboratorios Farmaceuticos Rovi SA.
What a Generic Risvan Means for You
Nothing Changes Until It Is in Pharmacies
A generic is listed for sale now, so your pharmacy may already be able to fill your prescription with it.
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.
Questions people ask about Risvan
Is there a generic for Risvan right now?
Yes. The FDA NDC Directory lists a generic risperidone from 1 company. Ask your pharmacy whether it can fill your prescription with it.
When will Risvan go generic?
It already has. The FDA NDC Directory lists a generic risperidone from 1 company, so ask your pharmacy whether it can fill your prescription with one.
Will generic risperidone be the same as Risvan?
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. The FDA has already approved 3 companies to make a generic, and how many of them launch decides how far the price falls.
Has the FDA approved a generic Risvan?
Yes. The FDA Orange Book lists approved generic versions from 3 companies, the first approved in December 2023: Teva Pharmaceuticals USA Inc, Amneal Eu Ltd and Nanomi BV. 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 Risvan patent expire?
The FDA Orange Book lists 14 patents for Risvan; the last runs to May 2031. The one behind the expected month is patents 10,058,504, 10,085,936, 10,182,982, 10,195,138 and 10 more, which end in May 2031. 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 (May 2031) weighs all of that.
Changes to This Projection
- First generic expected May 2031 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
- LampitNifurtimoxAugust 2027
- TaliciaAmoxicillin, Omeprazole Magnesium, and RifabutinNovember 2027
- Bevespi AerosphereFormoterol Fumarate and GlycopyrrolateMarch 2031
- EysuvisLoteprednol EtabonateMay 2033
- XolremdiMavorixaforApril 2038
- PaxlovidRitonavir and NirmatrelvirOctober 2041
About Risvan
- Generic name risperidone
- How it is taken Injection into a muscle
- Company Laboratorios Farmaceuticos Rovi SA
- Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
- More drugs Brand-name drugs starting with R
- Have a question? A pharmacist answers, free. Ask about Risvan
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.