Data updated: Mar 10, 2026
OSMOLEX ER
AMANTADINE HYDROCHLORIDE
Approved 2018-02-16
1
Indication
--
Phase 3 Trials
8
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2018-02-16
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
OSMOLEX ER Approval History
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What OSMOLEX ER Treats
1 FDA approvalsOriginally approved for its first indication in 2018 .
- Other (1)
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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
ProOSMOLEX ER Patents & Exclusivity
Latest Patent: Feb 2038
Patents (152 active)
US10213393
Expires Feb 15, 2038
US10213394
Expires Feb 15, 2038
US10500171
Expires Feb 15, 2038
US10500172
Expires Feb 15, 2038
US10500170
Expires Feb 15, 2038
US10512617
Expires Feb 15, 2038
US11890261
Expires Feb 15, 2038
US8252331
Expires Mar 13, 2030
US8389578
Expires Jan 22, 2028
+ 142 more patents
Source: FDA Orange Book
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.