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Paliperidone extended-release

Phase 3
Johnson & Johnson (JNJ)

Phase 3

Development Phase

0

Upcoming Catalysts

0

Historical Events

5

Regulatory Approvals

No Catalysts Found

No catalyst events have been recorded for this drug yet.

Competitive Landscape

3 competitors in Bipolar Disorder

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Drug Information

Target Indication

Bipolar Disorder

Clinical Trial

NCT00299715

Last updated: 12/4/2025

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Regulatory Approvals
EMA3/31/2024

Niapelf

indicated for maintenance treatment of schizophrenia in adult patients stabilised withpaliperidone or risperidone. In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, Niapelf may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.

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EMA6/18/2020

Byannli (previously Paliperidone Janssen-Cilag International)

Byannli (previously Paliperidone Janssen-Cilag International) a 6 monthly injection, is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1 monthly or 3 monthly paliperidone palmitate injectable products (see section 5.1).

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EMA12/5/2014

Trevicta (previously Paliperidone Janssen)

Trevicta, a 3 monthly injection, is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1 monthly paliperidone palmitate injectable product.

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EMA3/4/2011

Xeplion

Xeplion is indicated for maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone. In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, Xeplion may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.

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EMA6/24/2007

Invega

Invega is indicated for the treatment of schizophrenia in adults and in adolescents 15 years and older. Invega is indicated for the treatment of schizoaffective disorder in adults.

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Drug Science
Mechanism of action & safety profile
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