VANTRELA ER (hydrocodone bitartrate)
Development Insights
Details
- Status
- Discontinued
- First Approved
- 2017-01-17
- Patent Cliff
- 2029
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
VANTRELA ER Approval History
What VANTRELA ER Treats
1 FDA approvalsOriginally approved for its first indication in 2017 .
- Other (1)
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06585163 | QEV-817-101 5R44DA055336 | Ph 1 | not yet recruiting | Study to Investigate the Safety, Tolerability and Pharmacokinetics of QEV-817 Oral Suspension |
| NCT01081912 results posted | ZX002-0801 | Ph 3 | completed | Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain |
| NCT01115569 results posted | ZX002-0802 | Ph 3 | completed | Long-Term Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Pain |
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.
VANTRELA ER FDA Label Details
VANTRELA ER Patents & Exclusivity
Patents (3 active)
Pro Intelligence Preview
Deep insights for VANTRELA ER
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2029
- • 75 active patents
Trial Analysis
- • 3 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