Paliperidone Palmitate

Treats schizophrenia. Sold as Invega Sustenna, Invega Trinza, Invega Hafyera, Erzofri. Every FDA application for this active ingredient: 3 branded and 5 generic.

As of Nov 15, 2026, FDA lists 8 applications for Paliperidone Palmitate (sold as Invega Sustenna, Invega Trinza, Invega Hafyera and others), first approved Jul 31, 2009, with 5 new uses approved and 0 published complete response letters.

First approved: Jul 31, 2009
Applications: 8
New uses approved: 5
Complete response letters: 0
Medicare spending, 2025: $2.68B
First approved in Japan: Sep 20, 2013

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Invega Sustenna	Part D	$1.95B	+4%	71,656
Invega Trinza	Part D	$575M	+5%	19,031
Invega Hafyera	Part D	$135M	+23%	3,964
Invega Hafyera (J2426)	Part B	$17.6M	+0%	1,653
Invega Hafyera (J2427)	Part B	$4.4M	+23%	307
Erzofri	Part D	$1.3M	New	131
ERZOFRI	Part B	$505K	New	64

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

INVEGA SUSTENNA 117 MG/0.75 ML: $2337.70 per MLBrand · +2% in a year
INVEGA SUSTENNA 156 MG/ML SYRG: $2336.30 per MLBrand · +2% in a year
INVEGA SUSTENNA 234 MG/1.5 ML: $2337.80 per MLBrand · +2% in a year
INVEGA SUSTENNA 39 MG/0.25 ML: $2338.70 per MLBrand · +3% in a year
INVEGA SUSTENNA 78 MG/0.5 ML: $2336.50 per MLBrand · +2% in a year
INVEGA TRINZA 273 MG/0.88 ML: $3950.90 per MLBrand · +2% in a year
INVEGA TRINZA 410 MG/1.32 ML: $3959.50 per MLBrand · +2% in a year
INVEGA TRINZA 546 MG/1.75 ML: $4001.80 per MLBrand · +3% in a year
INVEGA TRINZA 819 MG/2.63 ML: $4001.00 per MLBrand · +3% in a year
INVEGA HAFYERA 1,092 MG/3.5 ML: $4047.70 per MLBrand · +3% in a year
INVEGA HAFYERA 1,560 MG/5 ML: $4233.40 per MLBrand · +2% in a year

Approvals in Japan (PMDA)

First approved in Japan 50 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Xeplion TRI Aqueous, new approvalDrugs with a new indication in a new dosage form for the treatment of schizophrenia (for use only in patients after they have been adequately treated with… · Janssen Pharmaceutical K.K. · Sep 25, 2020
Xeplion Aqueous, new ingredientDrugs with a new active ingredient indicated for the treatment of schizophrenia. · Janssen Pharmaceutical K.K. · Sep 20, 2013

Clinical Trials

5 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Higher-Dose Maintenance With ERZOFRI 351 mg in Adults With SchizophreniaSCHIZOPHRENIA 1 (Disorder) · Alejandro Alva	Phase 4	Not yet recruiting	Nov 10, 2026
A Bioequivalence Study of PP3M in Patients With SchizophreniaSchizophrenia · CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.	Not applicable	Recruiting	Mar 25, 2026
Efficacy and Functional Recovery After Switching From Paliperidone Palmitate Injection to Oral Antipsychotics in SchizophreniaSchizophrenia · Jiangsu Province Nanjing Brain Hospital	Phase 4	Not yet recruiting	Jul 20, 2025
Τhe Combination of Pharmacotherapy With RECOVERYTRSGR and RECOVERYTRSBDGR.Treatment Resistant Schizophrenia, Treatment Resistant Bipolar Disorder · Dr. Stavroula Rakitzi	Phase 4	Active, not recruiting	Jul 2, 2025
"Extended" (Alternate Day) Antipsychotic DosingSchizophrenia and Related Disorders, Drug Administration Schedule · Centre for Addiction and Mental Health	Phase 4	Recruiting	Jul 21, 2020

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jul 31, 2009	Invega SustennaNDA 22264 · New dosage form	Janssen Pharms	24	Marketed
May 18, 2015	Invega Trinza, Invega HafyeraNDA 207946 · New formulation or manufacturer	Janssen Pharms	10	Marketed
Jul 26, 2024	ErzofriNDA 216352 · New formulation or manufacturer	Luye Innomind Pharma	1	Marketed
—	Paliperidone PalmitateANDA 210397	Pharmascience Inc	0	Discontinued
—	Paliperidone PalmitateANDA 211995	Tolmar	0	Discontinued
—	Paliperidone PalmitateANDA 215682	Mylan Pharmaceuticals Inc A Viatris Co	0	Discontinued
—	Paliperidone PalmitateANDA 216228	Mylan Pharms Inc	0	Discontinued
—	Paliperidone PalmitateANDA 216674	Accord Hlthcare Inc	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA