NDAORALTABLET, EXTENDED RELEASE
Approved
Apr 2007
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
INVEGA (paliperidone) by Johnson & Johnson is risperidone. First approved in 2007.
Drug data last refreshed 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
INVEGA (paliperidone) is an oral atypical antipsychotic approved in 2007 for schizophrenia and schizoaffective disorder. It works through dopamine D2 and serotonin 5HT2A receptor antagonism, mechanisms shared with its parent compound risperidone. The extended-release tablet formulation enables once-daily dosing, improving patient adherence.
$0.005BPart D
LOE ApproachingDeclining
As LOE approaches, the brand team is likely consolidating; opportunities exist in managed markets and therapy switching strategies rather than growth-phase expansion.
Mechanism of Action
risperidone. The mechanism of action of paliperidone in schizophrenia is unclear. However, the drug's therapeutic effect in schizophrenia could be mediated through a combination of central dopamine Type 2 (D 2 ) and serotonin Type 2 (5HT 2A ) receptor antagonism.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Efficacy and Safety of Paliperidone in Schizophrenia - Bangladesh Study
Started Sep 2025
505 enrolled
Schizophrenia
A Study to Assess the Treatment of Schizophrenia With Paliperidone Palmitate in Rwandan Healthcare Settings
Started Jul 2021
93 enrolled
Schizophrenia
Evaluate the PK of LY03010 Process 1 and Process 2 Drug Product vs INVEGA SUSTENNA After Intramuscular Injection in Schizophrenia Patients
Started Jan 2020
36 enrolled
Schizophrenia Patients
A Study of Paliperidone Palmitate 6-Month Formulation
Started Sep 2019
178 enrolled
Schizophrenia
A Study to Determine Pharmacokinetic Characteristics of LY03010 Versus INVEGA SUSTENNA® in Schizophrenia Patients
Started Dec 2018
48 enrolled
Schizo Affective DisorderSchizophreniaSchizoaffective Disorder
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.