NDAINTRAMUSCULARSUSPENSION, EXTENDED RELEASE
Approved
Jul 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
ERZOFRI (paliperidone palmitate) by Accord Biopharma is [see ] . Approved for schizophrenia. First approved in 2024.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ERZOFRI (paliperidone palmitate) is an intramuscular extended-release antipsychotic suspension approved in July 2024 by Accord Biopharma. It treats schizophrenia, schizoaffective disorder, bipolar disorder, and other psychotic and mood disorders through dopamine D2 and serotonin 5HT2A receptor antagonism. This product is a generic equivalent to the established paliperidone palmitate franchise already dominated by Johnson & Johnson.
Growth13.4 years to LOE
Early-stage generic launch in a crowded IM antipsychotic market offers limited growth runway; team will focus on rapid market penetration and cost-competitive positioning.
Mechanism of Action
[see ] . Paliperidone is the major active metabolite of risperidone. The mechanism of action of paliperidone in the listed indications is unclear. However, the drug's effect in schizophrenia could be mediated through a combination of central dopamine Type 2 (D 2) and serotonin Type 2 (5HT 2A )…
Indications (1)
Clinical Trials (20)
A Study to Assess the Treatment of Schizophrenia With Paliperidone Palmitate in Rwandan Healthcare Settings
Started Jul 2021
93 enrolled
Schizophrenia
A Study of Paliperidone Palmitate 6-Month Formulation
Started Sep 2019
178 enrolled
Schizophrenia
A Survey to Collect Treatment Experience Feedback From Patients, Physicians, Nurses and Carers After Switching to Paliperidone Palmitate 3-monthly
Started Nov 2018
225 enrolled
Schizophrenia
A Study to Evaluate the Ability of Conducting a Study of Oral Risperidone Followed by Paliperidone Palmitate in Rwandan Healthcare Facilities
Started Oct 2018
34 enrolled
Schizophrenia
A Study to Analyze the Impact of Treatment With Paliperidone Palmitate on Clinical Outcomes and Hospital Resource Utilization in Adult Participants With Schizophrenia in Portugal
Started Aug 2018
55 enrolled
Schizophrenia
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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.