Last reviewed · How we verify
Esketamine 56 mg
Esketamine 56 mg, marketed by Janssen Research & Development, LLC, holds a significant position in the pharmaceutical market with a key composition patent expiring in 2028. The drug's primary strength lies in its unique mechanism of action, which differentiates it from competitors. The primary risk is the patent expiry in 2028, which could lead to increased competition from generic versions.
At a glance
| Generic name | Esketamine 56 mg |
|---|---|
| Also known as | JNJ-54135419 |
| Sponsor | Janssen Research & Development, LLC |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
Common side effects
Key clinical trials
- A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder (PHASE3)
- A Study of Esketamine Nasal Spray in Korean Participants With Treatment-resistant Depression (PHASE4)
- Virtual Reality-Based Mindfulness as an Adjunct to Treatment as Usual in Treatment-Resistant Depression (NA)
- Comparison of Esketamine Nasal Spray vs.Aripiprazole in Treat.Resistant Major Depressive Disorder in Elderly Patients (PHASE3)
- Pre-Approval Access to Esketamine Nasal Spray for the Treatment of Treatment-Resistant Depression (TRD)
- Comparative Effectiveness Study of Two Forms of Ketamine for Treatment-resistant Depression (PHASE4)
- A Double-blind Study to Assess the Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Participants Who Are Assessed to be at Imminent Risk for Suicide (PHASE2)
- A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended Release, Both in Combination With a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor, in Participants With Treatment Resistant Major Depressive Disorder (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Esketamine 56 mg CI brief — competitive landscape report
- Esketamine 56 mg updates RSS · CI watch RSS
- Janssen Research & Development, LLC portfolio CI