Erzofri Generic: When Will Generic Paliperidone Palmitate 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
Erzofri Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2034 to 2035 A wide window Why then?
- Has the FDA approved a generic? Not yet 1 company holds a tentative approval Why not yet?
- When does the last patent end? September 2039 2 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Not yet No company lists one for sale
Generic paliperidone palmitate is expected to be available between 2034 and 2035. None is for sale yet.
Why 2034 to 2035?
The patent fight is likely to end in an agreement that sets the launch. The terms are not public yet. We rate it toss-up: still unsettled. Just as likely to slip as to hold.
If Erzofri’s last patent runs to September 2039, how can a generic come sooner?
The 2 patents that run past the expected month, to September 2039 (12,128,049 and 11,666,573), cover 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. One company already holds a “tentative” approval, the FDA’s word for a generic that is ready but still blocked: Tolmar (June 2023). See who is lined up
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 Erzofri 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.
Erzofri 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
- Toss-up Still unsettled. Just as likely to slip as to hold.
- Price competition
- None filed yet No filers on record
- Brand sales
- Sales not reported
- FDA approved 2024 July 2024 FDA Orange Book
- Patents listed 2 last runs to September 2039 A generic is expected sooner, between 2034 and 2035. See why FDA Orange Book
- Medicare Part D spent $1.3M in 2025, for 131 people CMS Part D Spending by Drug
Erzofri’s Road to a Generic
Erzofri has had the market to itself since the FDA approved it in July 2024 (Luye Innomind Pharma (Shijiazhuang) Co Ltd). Its 2 listed patents run to September 2039.
The first generic of Erzofri is expected between 2034 and 2035.
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 September 2039
The last listed patent runs to September 2039, 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.
Erzofri Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Erzofri’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 |
|---|---|---|---|
| 12,128,049 | A way of using it (U-3968, U-3969) | October 2038 | Active |
| 11,666,573 | A way of using it (U-3968, U-3969) | September 2039 | Active |
Source: FDA Orange Book, application 216352. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Paliperidone Palmitate
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 Erzofri yet.
The FDA has tentatively approved one company’s generic: Tolmar (June 2023). A tentative approval means the generic is ready, but a patent or exclusivity still stops the FDA from giving it final approval.
Approved by the FDA
Not yet. The FDA has not approved a generic paliperidone palmitate. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic paliperidone palmitate 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).
Erzofri 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 Erzofri, 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 Erzofri
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 Erzofri, before manufacturer rebates.
- $1.4M
- January to March 2026, the latest CMS has posted
For 209 people, about $3,960 per prescription fill - $1.3M
- 2025, the whole year
For 131 people, about $4,119 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $1,390,094 | 209 | $3,960.38 |
| 2025 | $1,330,361 | 131 | $4,118.77 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Erzofri 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, schizoaffective disorder). Paliperidone belongs to a class of drugs known as atypical antipsychotics.
Erzofri Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 117MG/0.75ML (117MG/0.75ML) | Suspension, extended release | Intramuscular | July 2024 | Prescription reference product |
| 156MG/ML (156MG/ML) | Suspension, extended release | Intramuscular | July 2024 | Prescription reference product |
| 234MG/1.5ML (156MG/ML) | Suspension, extended release | Intramuscular | July 2024 | Prescription reference product |
| 351MG/2.25ML (156MG/ML) | Suspension, extended release | Intramuscular | July 2024 | Prescription reference product |
| 39MG/0.25ML (39MG/0.25ML) | Suspension, extended release | Intramuscular | July 2024 | Prescription reference product |
| 78MG/0.5ML (78MG/0.5ML) | Suspension, extended release | Intramuscular | July 2024 | Prescription reference product |
Source: FDA Orange Book, Luye Innomind Pharma (Shijiazhuang) Co Ltd.
What a Generic Erzofri Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Erzofri 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 Erzofri”. 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 Erzofri
Is there a generic for Erzofri right now?
No. As of October 9, 2026 no generic paliperidone palmitate is listed for sale in the FDA NDC Directory.
When will Erzofri go generic?
2034 to 2035 is the expected window, and that is toss-up 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 September 2039, but it covers a way of using it, not the medicine itself, which a generic can often work around or challenge.
Will generic paliperidone palmitate be the same as Erzofri?
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 Erzofri?
Not yet. The FDA Orange Book lists no approved generic version of Erzofri.
When does the Erzofri patent expire?
The FDA Orange Book lists 2 patents for Erzofri; the last runs to September 2039. 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 (2034 to 2035) weighs all of that.
Changes to This Projection
- First generic expected 2034 to 2035 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
- NayzilamMidazolamJanuary 2028
- Cuvrior BDTrientine TetrahydrochlorideApril 2029
- ValtocoDiazepam2030 to 2031
- Abilify AsimtufiiAripiprazoleApril 2033
- IdhifaEnasidenib MesylateSeptember 2034
- RezlidhiaOlutasidenib2037 to 2038
About Erzofri
- Generic name paliperidone palmitate
- How it is taken Injection into a muscle
- Company Luye Innomind Pharma (Shijiazhuang) Co Ltd
- 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 E
- Have a question? A pharmacist answers, free. Ask about Erzofri
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, CMS Medicare Part D Spending by Drug, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.