Uzedy Generic: When Will Generic Risperidone Be Available?

Dr. Brian Staiger, PharmD, BCPS

This page is aggregated from FDA records, court filings and company announcements. Coded and designed by

Updated October 9, 2026 How we build our data

Uzedy Generic at a Glance

Four quick answers from FDA records and our estimate.

  1. When is the first generic expected? March 2042 About 15.5 years away Why then?
  2. Has the FDA approved a generic? Not yet None in the FDA’s records yet
  3. When does the brand’s protection end? March 2042 The last of 6 listed patents
  4. Can you buy a generic today? Yes 1 company lists one

Explains

PharmD, BCPS · Clinical pharmacist

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 March 2042?

It is when Uzedy’s patent 12,329,851 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.

What should I do now?

Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Uzedy, 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.

Uzedy 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
None filed yet No filers on record
Brand sales
$350M a yearBig seller
  • FDA approved 2023 April 2023 FDA Orange Book
  • Patents listed 6 last runs to March 2042 FDA Orange Book
  • Pharmacies pay $9,451.01 per mL NADAC, October 2026
  • Medicare Part D spent $145.4M in 2025, for 8,307 people CMS Part D Spending by Drug
  • Medicaid prescriptions 77.2K in the last four reported quarters, $237.8M CMS Medicaid drug utilization, to Q1 2026

Uzedy’s Road to a Generic

Uzedy has had the market to itself since the FDA approved it in April 2023 (Teva Neuroscience Inc). Its FDA protections on record ended by April 2026. Its 6 listed patents run to March 2042.

The first generic of Uzedy is expected in March 2042.

Why that month: patent 12,329,851, on a way of using it, ends then.

Brand alone on the market Since FDA approval, April 2023
New product Ended April 2026
Patent 8,221,778 Expires November 2027
Patent 8,741,327 Expires November 2027
Patent 9,023,897 Expires April 2033
Patent 12,128,132 Expires September 2040
Patent 12,383,493 Expires September 2040
Patent 12,329,851 Expires March 2042 The patent behind the expected month of generic availability
Brand alone on the market FDA exclusivity Patent on the formulation Patent on a use First generic expected Swipe the chart sideways to see every year.

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.

Uzedy Patents and FDA Protections

Every patent and exclusivity the FDA Orange Book lists for Uzedy’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 12,329,851, which ends in March 2042, the month the first generic is expected.

Patents listed with the FDA (6)
PatentWhat it coversProtects untilStatus
8,221,778 The product’s formulation; a way of using it (U-601, U-543) November 2027 Active
8,741,327 The product’s formulation; a way of using it (U-543) November 2027 Active
9,023,897 The product’s formulation April 2033 Active
12,128,132 The product’s formulation; a way of using it (U-601, U-543) September 2040 Active
12,383,493 The product’s formulation; a way of using it (U-601, U-543) September 2040 Active
12,329,851 Sets the expected month of generic availability A way of using it (U-4214) March 2042 Active
FDA exclusivities (1)
ExclusivityWhat it meansEndsStatus
New product NPThree years of protection for a change that needed new clinical studies.April 2026Ended

Source: FDA Orange Book, application 213586. 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.

1

Applied to the FDA

No company is recorded as having applied to the FDA to make a generic Uzedy yet.

2

Approved by the FDA

Not yet. The FDA has not approved a generic risperidone. Final approval often comes close to the day a generic can be sold.

3

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

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).

Uzedy Price: What Pharmacies Pay and What Generics Usually Do

What Pharmacies Pay for Uzedy ER 50 mg/0.14 mL syringe

$9,451.01 per mL in October 2026.

Hover over or tap anywhere on the chart to see that month’s price.

  • Uzedy ER 50 mg/0.14 mL syringe $9,451.01 per mL
  • Uzedy ER 75 mg/0.21 mL syringe $9,358.66 per mL
  • Uzedy ER 100 mg/0.28 mL syring $9,389.09 per mL
  • Uzedy ER 125 mg/0.35 mL syring $9,329.00 per mL
  • Uzedy ER 200 mg/0.56 mL syring $9,346.07 per mL
See the numbers
MonthPharmacies paid per mL
October 2026$9,451.01
September 2026$9,451.01
August 2026$9,451.01
July 2026$9,451.01
June 2026$9,451.01
May 2026$9,451.01
April 2026$9,451.01
March 2026$9,451.01
February 2026$9,451.01
January 2026$9,451.01

NADAC: the national average price retail pharmacies pay to buy the medicine (CMS survey, updated weekly), the last price of each month for one package. It is not what you pay: that depends on your insurance or discount card.

What a Generic Could Cost

How we estimate it. We start from what pharmacies pay for Uzedy today: $9,451.01 per mL for Uzedy ER 50 mg/0.14 mL syringe in October 2026, from the national NADAC survey. Then we apply the FDA’s finding of how far that price 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).

Dollar figures apply FDA’s median drops to the $9,451.01 pharmacies pay per mL today. An estimate from the pattern, not a price quote: what you pay depends on your insurance or discount card.

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 Uzedy

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.

Medicare Part D Spending

What Medicare drug plans spent on Uzedy, before manufacturer rebates.

$49.5M
January to March 2026, the latest CMS has posted
For 6,523 people, about $3,536 per prescription fill
$145.4M
2025, the whole year
For 8,307 people, about $3,368 per prescription fill
See the numbers
PeriodSpendingPeoplePer fill
January to March 2026$49,475,9326,523$3,535.76
2025$145,424,2328,307$3,368.02

Source: CMS Medicare Part D Spending by Drug, matched by the brand name Uzedy only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat certain mental/mood disorders (such as schizophrenia, bipolar disorder). Risperidone belongs to a class of drugs known as atypical antipsychotics.

Medicaid Prescriptions by Quarter

77,211 prescriptions in the four quarters to Q1 2026, $237.8M paid.

See the numbers
QuarterPrescriptionsMedicaid paid
Q1 202620,683$60,406,476
Q4 202521,303$66,641,524
Q3 202519,566$61,609,641
Q2 202515,659$49,164,435
Q1 202512,940$39,740,036

Source: CMS Medicaid State Drug Utilization Data, over Uzedy’s own package codes.

Uzedy Strengths and Forms

StrengthFormHow it is takenApprovedStatus
100MG/0.28ML (100MG/0.28ML)Suspension, extended releaseSubcutaneousApril 2023Prescription reference product
125MG/0.35ML (125MG/0.35ML)Suspension, extended releaseSubcutaneousApril 2023Prescription reference product
150MG/0.42ML (150MG/0.42ML)Suspension, extended releaseSubcutaneousApril 2023Prescription reference product
200MG/0.56ML (200MG/0.56ML)Suspension, extended releaseSubcutaneousApril 2023Prescription reference product
250MG/0.7ML (250MG/0.7ML)Suspension, extended releaseSubcutaneousApril 2023Prescription reference product
50MG/0.14ML (50MG/0.14ML)Suspension, extended releaseSubcutaneousApril 2023Prescription reference product
75MG/0.21ML (75MG/0.21ML)Suspension, extended releaseSubcutaneousApril 2023Prescription reference product

Source: FDA Orange Book, Teva Neuroscience Inc. Listed for sale today by Teva Pharmaceuticals USA, Inc. (FDA NDC Directory).

Uzedy NDC Codes and Packages

Each Uzedy 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.

Uzedy packages (28)
NDCProductPackageCompany
51759-0520-10RISPERIDONE 100 mg/.28mL injection, suspension, extended releasesyringe of .28 mLTeva Pharmaceuticals USA, Inc.
51759-0520-10RISPERIDONE 100 mg/.28mL injection, suspension, extended releasesyringe of .28 mLTeva Pharmaceuticals USA, Inc.
51759-0520-11RISPERIDONE 100 mg/.28mL injection, suspension, extended releasesyringe of .28 mLTeva Pharmaceuticals USA, Inc.
51759-0520-11RISPERIDONE 100 mg/.28mL injection, suspension, extended releasesyringe of .28 mLTeva Pharmaceuticals USA, Inc.
51759-0630-10RISPERIDONE 125 mg/.35mL injection, suspension, extended releasesyringe of .35 mLTeva Pharmaceuticals USA, Inc.
51759-0630-10RISPERIDONE 125 mg/.35mL injection, suspension, extended releasesyringe of .35 mLTeva Pharmaceuticals USA, Inc.
51759-0630-11RISPERIDONE 125 mg/.35mL injection, suspension, extended releasesyringe of .35 mLTeva Pharmaceuticals USA, Inc.
51759-0630-11RISPERIDONE 125 mg/.35mL injection, suspension, extended releasesyringe of .35 mLTeva Pharmaceuticals USA, Inc.
Show the other 20 Uzedy packages
NDCProductPackageCompany
51759-0740-10RISPERIDONE 150 mg/.42mL injection, suspension, extended releasesyringe of .42 mLTeva Pharmaceuticals USA, Inc.
51759-0740-10RISPERIDONE 150 mg/.42mL injection, suspension, extended releasesyringe of .42 mLTeva Pharmaceuticals USA, Inc.
51759-0740-11RISPERIDONE 150 mg/.42mL injection, suspension, extended releasesyringe of .42 mLTeva Pharmaceuticals USA, Inc.
51759-0740-11RISPERIDONE 150 mg/.42mL injection, suspension, extended releasesyringe of .42 mLTeva Pharmaceuticals USA, Inc.
51759-0850-10RISPERIDONE 200 mg/.56mL injection, suspension, extended releasesyringe of .56 mLTeva Pharmaceuticals USA, Inc.
51759-0850-10RISPERIDONE 200 mg/.56mL injection, suspension, extended releasesyringe of .56 mLTeva Pharmaceuticals USA, Inc.
51759-0850-11RISPERIDONE 200 mg/.56mL injection, suspension, extended releasesyringe of .56 mLTeva Pharmaceuticals USA, Inc.
51759-0850-11RISPERIDONE 200 mg/.56mL injection, suspension, extended releasesyringe of .56 mLTeva Pharmaceuticals USA, Inc.
51759-0960-10RISPERIDONE 250 mg/.7mL injection, suspension, extended releasesyringe of .7 mLTeva Pharmaceuticals USA, Inc.
51759-0960-10RISPERIDONE 250 mg/.7mL injection, suspension, extended releasesyringe of .7 mLTeva Pharmaceuticals USA, Inc.
51759-0960-11RISPERIDONE 250 mg/.7mL injection, suspension, extended releasesyringe of .7 mLTeva Pharmaceuticals USA, Inc.
51759-0960-11RISPERIDONE 250 mg/.7mL injection, suspension, extended releasesyringe of .7 mLTeva Pharmaceuticals USA, Inc.
51759-0305-10RISPERIDONE 50 mg/.14mL injection, suspension, extended releasesyringe of .14 mLTeva Pharmaceuticals USA, Inc.
51759-0305-10RISPERIDONE 50 mg/.14mL injection, suspension, extended releasesyringe of .14 mLTeva Pharmaceuticals USA, Inc.
51759-0305-11RISPERIDONE 50 mg/.14mL injection, suspension, extended releasesyringe of .14 mLTeva Pharmaceuticals USA, Inc.
51759-0305-11RISPERIDONE 50 mg/.14mL injection, suspension, extended releasesyringe of .14 mLTeva Pharmaceuticals USA, Inc.
51759-0410-10RISPERIDONE 75 mg/.21mL injection, suspension, extended releasesyringe of .21 mLTeva Pharmaceuticals USA, Inc.
51759-0410-10RISPERIDONE 75 mg/.21mL injection, suspension, extended releasesyringe of .21 mLTeva Pharmaceuticals USA, Inc.
51759-0410-11RISPERIDONE 75 mg/.21mL injection, suspension, extended releasesyringe of .21 mLTeva Pharmaceuticals USA, Inc.
51759-0410-11RISPERIDONE 75 mg/.21mL injection, suspension, extended releasesyringe of .21 mLTeva Pharmaceuticals USA, Inc.

Source: the FDA NDC Directory, current listings only. Only packages sold under Uzedy’s own FDA approval (NDA 213586) are listed, never a generic. Some codes belong to companies that repackage Uzedy: it is the same medicine in a different package.

What a Generic Uzedy 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 Uzedy

Is there a generic for Uzedy 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 Uzedy 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 Uzedy?

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 Uzedy?

Not yet. The FDA Orange Book lists no approved generic version of Uzedy.

When does the Uzedy patent expire?

The FDA Orange Book lists 6 patents for Uzedy; the last runs to March 2042. The one behind the expected month is patent 12,329,851, which ends in March 2042. 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 (March 2042) weighs all of that.

How much does Uzedy cost now?

Pharmacies paid about $9,451.01 per mL for Uzedy ER 50 mg/0.14 mL syringe in October 2026, by the national survey of what pharmacies pay (NADAC). That is the pharmacy’s cost, not your price: what you pay depends on your insurance or discount card.

Changes to This Projection

  • First generic expected March 2042 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

All upcoming generics

About Uzedy

  • Generic name risperidone
  • How it is taken Injection under the skin
  • Company Teva Neuroscience Inc
  • 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 U
  • Have a question? A pharmacist answers, free. Ask about Uzedy

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, NADAC (CMS), CMS Medicare Part D Spending by Drug, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.