RIVIVE (naloxone hydrochloride)
Development Insights
Details
- Status
- Over-the-counter
- First Approved
- 2023-07-28
- Patent Cliff
- 2032
- Routes
- NASAL
- Dosage Forms
- SPRAY, METERED
RIVIVE Approval History
What RIVIVE Treats
1 FDA approvalsOriginally approved for its first indication in 2023 .
- Other (1)
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07459166 | CS-1103-03 5UG3DA059286 | Ph 2 | not yet recruiting | A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade |
| NCT04828005 results posted | OPNT003-PD-001 | Ph 1 | completed | Pharmacodynamic Evaluation of Intranasal Nalmefene |
| NCT04473950 results posted | Z-1902 R21DA047520 | Ph 1 | terminated | The Effect of Chronic Pain on Delay Discounting in Methadone Patients |
| NCT05338632 ROAR | P21.112 | Ph 1 | recruiting | Reversal of Opioid-induced Respiratory Depression With Opioid Antagonists |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
RIVIVE FDA Label Details
Pro Intelligence Preview
Deep insights for RIVIVE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2032
- • 3 active patents
Trial Analysis
- • 4 total trials
- • Stage: Stable
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment