Data updated: Mar 10, 2026
ADHANSIA XR
METHYLPHENIDATE HYDROCHLORIDE
Approved 2019-02-27
2
Indications
--
Phase 3 Trials
7
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2019-02-27
- Routes
- ORAL
- Dosage Forms
- CAPSULE, EXTENDED RELEASE
ADHANSIA XR Approval History
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What ADHANSIA XR Treats
2 FDA approvalsOriginally approved for its first indication in 2019 . Covers 2 distinct patient populations.
- Other (2)
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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.
ADHANSIA XR FDA Label Details
ProADHANSIA XR Patents & Exclusivity
Latest Patent: Nov 2038
Patents (432 active)
US10722473
Expires Nov 19, 2038
US10111839
Expires Oct 30, 2035
US10292939
Expires Oct 30, 2035
US10512613
Expires Oct 30, 2035
US10449159
Expires Oct 30, 2035
US10500162
Expires Oct 30, 2035
US10568841
Expires Oct 30, 2035
US10292938
Expires Oct 30, 2035
US10507186
Expires Oct 30, 2035
US10512612
Expires Oct 30, 2035
+ 422 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.