NDAORALTABLET, EXTENDED RELEASE
Approved
Dec 2006
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Drug data last refreshed Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
INVEGA (paliperidone) is an atypical antipsychotic oral tablet approved in 2006 for schizophrenia and schizoaffective disorder. It works by antagonizing dopamine D2 and serotonin 5-HT2A receptors in the central nervous system. The drug is a small-molecule formulation designed for extended-release delivery to improve patient compliance.
LOE Approaching
INVEGA is transitioning toward loss of exclusivity with moderate competitive pressure (30/100), suggesting downsizing of the brand team and shift to generics support roles.
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.