Quick answers
- What is Paliperidone palmitate used for?
- The FDA-approved label (Invega Sustenna, Janssen Pharmaceuticals, Inc., February 14, 2025) says: “INVEGA SUSTENNA (paliperidone palmitate) is indicated for the treatment of: Schizophrenia in adults […]. Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants […]. INVEGA SUSTENNA is an atypical antipsychotic indicated for Treatment of schizophrenia in adults. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Paliperidone palmitate have a boxed warning?
- Yes. The FDA label for Invega Sustenna has a boxed warning (“WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Paliperidone palmitate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Paliperidone palmitate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Paliperidone palmitate?
- 2 companies list prescription products of Paliperidone palmitate in the FDA NDC Directory, including Janssen Pharmaceuticals, Inc. and Shandong Luye Pharmaceutical Co., Ltd..
What Paliperidone palmitate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
INVEGA SUSTENNA (paliperidone palmitate) is indicated for the treatment of: Schizophrenia in adults […]. Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants […]. INVEGA SUSTENNA is an atypical antipsychotic indicated for Treatment of schizophrenia in adults. …
— FDA label: Invega Sustenna, Janssen Pharmaceuticals, Inc., effective February 14, 2025. Read the full label on DailyMed →
The FDA has 4 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
. Read it on the full label →
4 of 4 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection · Injection, suspension, extended release |
|---|---|
| Route | Intramuscular |
| Prescription products | 17 in the FDA NDC Directory |
| Brand names | Erzofri Extended-Release, Invega Sustenna, Invega Trinza, Invega Hafyera |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| paliperidone palmitate 1092 mg/3.5 mL injection, suspension, extended release | Brand: Invega Hafyera | $4,047.71 per mL |
| paliperidone palmitate 117 mg/0.75 mL injection | Brand: Invega Sustenna | $2,337.67 per mL |
| paliperidone palmitate 156 mg/mL injection | Brand: Invega Sustenna | $2,336.31 per mL |
| paliperidone palmitate 1560 mg/5 mL injection, suspension, extended release | Brand: Invega Hafyera | $4,233.40 per mL |
| paliperidone palmitate 234 mg/1.5 mL injection | Brand: Invega Sustenna | $2,337.82 per mL |
| paliperidone palmitate 273 mg/0.88 mL injection, suspension, extended release | Brand: Invega Trinza | $3,950.95 per mL |
| paliperidone palmitate 39 mg/0.25 mL injection | Brand: Invega Sustenna | $2,338.75 per mL |
| paliperidone palmitate 410 mg/1.32 mL injection, suspension, extended release | Brand: Invega Trinza | $3,959.46 per mL |
| paliperidone palmitate 546 mg/1.75 mL injection, suspension, extended release | Brand: Invega Trinza | $4,001.75 per mL |
| paliperidone palmitate 78 mg/0.5 mL injection | Brand: Invega Sustenna | $2,336.48 per mL |
| paliperidone palmitate 819 mg/2.63 mL injection, suspension, extended release | Brand: Invega Trinza | $4,000.98 per mL |
NADAC list of November 4, 2026; these prices took effect between January 2, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Janssen Pharmaceuticals, Inc.11 products
- Shandong Luye Pharmaceutical Co., Ltd.6 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022264 INVEGA SUSTENNA | Janssen Pharms | July 31, 2009 | 24, latest January 23, 2025 2025: Labeling · 2024: Labeling · 2022: Labeling |
| NDA207946 INVEGA HAFYERA, INVEGA TRINZA | Janssen Pharms | May 18, 2015 | 10, latest January 23, 2025 2025: Labeling · 2024: Labeling · 2024: Labeling |
| NDA216352 ERZOFRI | Luye Innomind Pharma | July 26, 2024 | 1, latest January 22, 2025 2025: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Invega Sustenna, Janssen Pharmaceuticals, Inc., effective February 14, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →