OSMOLEX ER (amantadine hydrochloride)
Development Insights
Details
- Status
- Discontinued
- First Approved
- 2018-02-16
- Patent Cliff
- 2038
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
OSMOLEX ER Approval History
What OSMOLEX ER Treats
1 FDA approvalsOriginally approved for its first indication in 2018 .
- Other (1)
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06253923 | MR-301-T-001 | Ph 2 | active not recruiting | Study to Assess the Safety of Amantadine Hydrochloride (HCl) Intravenous (IV) Solution (MR-301) in Patients With Severe Traumatic Brain Injury (TBI). |
| NCT04273737 results posted | AAAS1907 | Ph 4 | terminated | Amantadine in Treating Cognitive & Motor Impairments in Adolescents and Adults With Cerebral Palsy |
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.
OSMOLEX ER FDA Label Details
OSMOLEX ER Patents & Exclusivity
Patents (9 active)
Pro Intelligence Preview
Deep insights for OSMOLEX ER
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2038
- • 152 active patents
Trial Analysis
- • 13 total trials
- • Stage: Declining
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