Mezofy

(Aripiprazole tablet)

Otsuka

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Timeline

Expected Milestones

Q4 2027

Phase 2Not yet recruiting

Schizophrenia

NCT07703956

Clinical

Trials by Indication[1]

Schizophrenia1 trial

A Phase 2,Multicenter, Randomized, Double-blind, Placebo and Active Comparator Parallel-controlled Study to Evaluate the Safety and Efficacy of VV119 in Adults With Acute Schizophrenia

Not yet recruiting·VVigonvita Life Sciences·Phase 2·NCT07703956·500 enrolled

Regulatory

FDA Approval Timeline[3]

Nov 15, 2002

ABILIFY

NDA NDA021436

Dec 10, 2004

ABILIFY

NDA NDA021713

Jun 7, 2006

ABILIFY

NDA NDA021729

Sep 20, 2006

ABILIFY

NDA NDA021866

Feb 28, 2013

ABILIFY MAINTENA KIT

NDA NDA202971

Nov 13, 2017

ABILIFY MYCITE KIT

NDA NDA207202

Apr 27, 2023

ABILIFY ASIMTUFII

NDA NDA217006

Jul 22, 2024

OPIPZA

NDA NDA216655

Apr 15, 2025

MEZOFY

NDA NDA211448

Sources

References

[1]
ClinicalTrials.gov — 1 trial record for Aripiprazole tablet. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Aripiprazole tablet compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA211448). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Mezofy. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Otsuka company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Company: Otsuka

Patent Landscape[4]

Patent Cliff

Apr 1, 2041

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12691056Apr 1, 2041

Mezofy

Expected Milestones

Q4 2027

Trials by Indication[1]

Schizophrenia1 trial

FDA Approval Timeline[3]

References

Drug Info

Quick Facts

Patent Landscape[4]

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