TheraRadar
Data updated: May 26, 2026

ADHANSIA XR (methylphenidate hydrochloride)

CNS Approved 2019-02-27
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
7
Years on Market

Details

Status
Discontinued
First Approved
2019-02-27
Patent Cliff
2038

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Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
CAPSULE, EXTENDED RELEASE

Companies

PURDUE PHARMA LP
Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE

ADHANSIA XR Approval History

2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
24 FDA actions from 2019 to 2021 · 1 indication expansions
Jun 2021 SUPPL
Efficacy
FDA Letter Label
Jun 2021 SUPPL
Label · Labeling
FDA Letter Label
Jul 2019 SUPPL
Label · Labeling
FDA Letter Label

What ADHANSIA XR Treats

2 FDA approvals

Originally approved for its first indication in 2019 . Covers 2 distinct patient populations.

  • Other (2)
📋

Clinical Trial Registry

16 trials
Trial Sponsor ID Phase Status Title
NCT01628029 results posted 2012-0120 NCI-2012-01352, 2012-0120 Ph 2 active not recruiting Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer
NCT05185583 77169 Ph 2 completed Methylphenidate in Childhood Apraxia of Speech
NCT06465641 KBGS_N_of_1 113883 Ph 4 recruiting Methylphenidate in KBG Syndrome: N-of-1 Series
NCT04987762 results posted ADA4004 Ph 4 terminated Safety and Tolerability Study of Adhansia XR® Extended-Release Capsules in Children
NCT04507204 RE-DAX results posted ADA4003 Ph 4 terminated Real-World Evidence of Duration of Effect of Adhansia XR (Extended-Release) for Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD)
NCT04152629 reFOQus CAN-MA-FOQ-001 Ph 4 completed Real World Evidence of the Efficacy and Safety of FOQUEST
NCT00763971 results posted SPD489-325 2008-000679-90 Ph 3 completed Randomized, Double-blind Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17
NCT01552902 results posted SPD489-406 2011-005452-34 Ph 4 completed Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder
NCT01183234 results posted SPD544-101 Ph 1 completed SPD544 High Strength Bioequivalence Study
NCT01552915 results posted SPD489-405 Ph 4 completed Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder
NCT02247986 140193 14-M-0193 Ph 1, Ph 2 withdrawn Investigating the Impact of Methylphenidate on Neural Response in Disruptive Behavioral Disorder
NCT01914822 275-13-RMB Ritalin version 5 Ph 2 completed The Effect Methylphenidate Hydrochloride on Pain and Auditory Sensitivity in Healthy Subjects
NCT00376675 results posted NCCTG-N05C7 NCI-2012-02701, CDR0000495148 Ph 3 completed Methylphenidate in Treating Patients With Fatigue Caused by Cancer
NCT00593853 LEUPR_L_01 07-0350-C Ph 2 terminated Efficacy Study of Methylphenidate Hydrochloride to Reduce Fatigue in Prostate Cancer Patients Receiving Hormone Therapy
NCT01348607 results posted SCUSF 0803 SCUSF-0803, 5U10CA081920-11 Ph 2 terminated Methylphenidate HCl or Modafinil in Treating Young Patients With Excessive Daytime Sleepiness After Cancer Therapy
NCT00730249 QUMEA 6520-0650-13 Ph 3 completed Quality Assurance of Administering Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD) - QUMEA
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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

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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

View full patent landscape →
12 OB patents · 2 families · 74 international docs across 18 countries

ADHANSIA XR Patents & Exclusivity

Latest Patent: Nov 2038

Patents (12 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
US10688060 Expires Oct 30, 2035
US9974752 Expires Oct 30, 2035
Source: FDA Orange Book

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Revenue Insights

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Patent Timeline

  • • Cliff: 2038
  • • 432 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA212038 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.