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 10h 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 the treatment of schizophrenia and schizoaffective disorder. It is a dopamine and serotonin antagonist that reduces psychotic symptoms by modulating neurotransmitter activity in the brain. The drug is indicated for patients with psychotic disorders requiring sustained antipsychotic coverage.
LOE Approaching
As a mature product approaching loss of exclusivity with moderate competitive pressure (30%), brand teams should anticipate resource reallocation toward line extensions or newer mechanisms while maintaining market share through cost and access strategies.
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.