NDAORALTABLET, EXTENDED RELEASE
Approved
Dec 2006
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
INVEGA (paliperidone) by Johnson & Johnson. Approved for atypical antipsychotic [epc]. First approved in 2006.
Drug data last refreshed 15m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
INVEGA (paliperidone) is an atypical antipsychotic oral extended-release tablet approved in 2006 for schizophrenia and related psychotic disorders. It works by modulating dopamine and serotonin receptors in the central nervous system to reduce positive and negative symptoms of psychosis.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100); declining revenue trajectory suggests downsizing of brand team and transition planning underway.
Mechanism of Action
Pharmacologic Class:
Atypical Antipsychotic
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.