NDAORALSUSPENSION
Approved
Feb 2013
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
6/8 — Strong
VERSACLOZ (clozapine) by Aurobindo Pharma is unknown. Approved for schizophrenia, schizoaffective disorder, psychotic disorder. First approved in 2013.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VERSACLOZ is an oral suspension formulation of clozapine, an atypical antipsychotic approved in 2013 for schizophrenia, schizoaffective disorder, and related psychotic conditions. It works primarily through antagonism of dopamine D2 and serotonin 5-HT2A receptors, with additional activity at adrenergic, cholinergic, and histaminergic receptors. The suspension formulation addresses administration challenges in patients who have difficulty swallowing tablets.
$0.001BPart D
LOE Approaching2.0 years to LOEVERSACLOZ faces imminent loss of exclusivity in 2028 with minimal current market penetration ($1M spending), signaling a contracting team and focus on transition planning rather than growth.
Mechanism of Action
unknown. However, it has been proposed that the therapeutic efficacy of Clozapine ODT in schizophrenia is mediated through antagonism of the dopamine type 2 (D 2 ) and the serotonin type 2A (5-HT 2A ) receptors. Clozapine also acts as an antagonist at adrenergic, cholinergic, histaminergic and…
Pharmacologic Class:
Atypical Antipsychotic
Indications (3)
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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.