COTEMPLA XR-ODT (methylphenidate)
Cotempla XR-ODT is a central nervous system stimulant used for children and adolescents between the ages of 6 and 17 who have Attention Deficit Hyperactivity Disorder (ADHD). It helps patients in this age group manage their symptoms, though it is not recommended for children under 6 years old. Younger children are excluded because they may experience higher drug exposure and more frequent side effects, such as weight loss, compared to older patients.
How COTEMPLA XR-ODT Works
This medication works as a central nervous system stimulant. While it treats ADHD, the specific way the drug produces its therapeutic effect is not currently known.
Details
- Status
- Prescription
- First Approved
- 2017-06-19
- PDUFA Date
- 2026-05-31 (5d)
- Patent Cliff
- 2038
- Routes
- ORAL
- Dosage Forms
- TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE
COTEMPLA XR-ODT Approval History
What COTEMPLA XR-ODT Treats
1 indicationsCOTEMPLA XR-ODT is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Attention Deficit Hyperactivity Disorder
COTEMPLA XR-ODT Boxed Warning
ABUSE, MISUSE, AND ADDICTION COTEMPLA XR-ODT has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including COTEMPLA XR-ODT, can result in overdose and death (5.1, 9.2, 10). Before prescribing COTEMPLA XR-ODT, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused dr...
WARNING: ABUSE, MISUSE, AND ADDICTION COTEMPLA XR-ODT has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including COTEMPLA XR-ODT, can result in overdose and death (5.1, 9.2, 10). Before prescribing COTEMPLA XR-ODT, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction. WARNING: ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete boxed warning. COTEMPLA XR-ODT has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including COTEMPLA XR-ODT, can result in overdose and death (5.1, 9.2, 10): • Before prescribing COTEMPLA XR-ODT, assess each patient’s risk for abuse, misuse, and addiction. • Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. • Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
COTEMPLA XR-ODT Competitive Set
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Indication competitors
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to COTEMPLA XR-ODT
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Clinical Trial Registry
78 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07314333 | 405-201-00198 | Ph 1 | completed | A Trial to Assess How Centanafadine Interacts With Stimulants in the Body |
| NCT03772834 | 2018-0559 NCI-2018-02527, 2018-0559 | Ph 2, Ph 3 | active not recruiting | Methylphenidate and Exercise in Reducing Cancer-Related Fatigue in Patients With Prostate Cancer |
| NCT04419272 | NURD-003-22S CX002474 | Ph 4 | recruiting | Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits |
| NCT03525873 | 2017-0913 NCI-2018-00698, 2017-0913 | Ph 3 | active not recruiting | A Study of Cancer Related Fatigue in Patients With Metastatic Cancer Receiving Anti-PD1 Immunotherapy |
| NCT01410942 | 2011-0389 RSG-11-170-01-PCSM, NCI-2011-02764 | Ph 2 | active not recruiting | Multimodal Therapy for the Treatment of Fatigue in Patients With Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy |
| NCT07301632 EASEPain | EASE Pain P-006 | Ph 2 | recruiting | Ecstasy to Alleviate SEvere Chronic Neuropathic Pain Trial |
| NCT03652740 results posted | IRB00165287 R01DA003890 | Ph 1 | completed | Effects of Commonly Used Medications on Mood and Choice |
| NCT05776056 IMPACT | MHBP-006-22S CX002546 | Ph 4 | recruiting | Methylphenidate for the Treatment of PTSD With Associated Neurocognitive Complaints |
| NCT03280251 PACTE-1 | 2015_81 2016-005131-32 | Ph 2 | completed | Methylphenidate and Cognitive Training in Elderly |
| NCT06081179 | 2A-SC-1 | Ph 1 | completed | Does Serotonin System Stimulation Increase Pro-social Behavior? - A Comparative Pharmacological Neuroscientific Study in Healthy Humans |
| NCT05474846 | 2022-0180 NCI-2022-06045 | Ph 2, Ph 3 | recruiting | Combination Therapy for Treatment of Sleep Disturbance in Patients With Advanced Cancer |
| NCT03814356 STIMPACT results posted | 140675 DP2HD101400 | Ph 1 | active not recruiting | Stimulant Therapy Targeted to Individualized Connectivity Maps to Promote ReACTivation of Consciousness |
| NCT04781972 | IRB00276357 | Ph 4 | recruiting | Multimodal Brain Imaging of the Neural Effects of Methylphenidate in Patients With ADHD |
| NCT06355414 | IRB00385932 R33AT012317 | Ph 1 | recruiting | Psilocybin in Chronic Low Back Pain and Depression |
| NCT06580041 | 24-41815 | Ph 4 | enrolling by invitation | Precision Care for Major Depressive Disorder |
| NCT04885257 results posted | MHBP-011-20F IK2CX002104 | Ph 1, Ph 2 | completed | Methylphenidate for Ptsd and Stroke Veterans |
| NCT04421248 AMPAIII | CHMC IRB 2020-0297 | Ph 4 | recruiting | Biomarker Validation in Motor System Physiology in Attention Deficit Hyperactivity Disorder |
| NCT03575403 BED[IN]:36 results posted | 44796 R01AA026255 | Ph 1 | completed | Behavioral Effects of Drugs: Inpatient (36) (Alcohol, Duloxetine, and Methylphenidate) |
| NCT05133804 | LH9/2019 | Ph 2 | recruiting | Efficacy of Reboxetine and Methylphenidate Treatment on Attentional, Sensory and Emotional Dysregulation in Adults With PTSD |
| NCT05285683 | STUDY00006948 | Ph 2 | recruiting | The Role of Brain Dopamine in Chronic Pain |
| NCT05957055 LAMAinDiab | LAMA/2021/1 2022-001906-24, 2021/ABM/02/00006/P/03 | Ph 2 | recruiting | Lisdexamphetamine Vs Methylphenidate for Pediatric Patients with ADHD and Type 1 Diabetes |
| NCT00792662 | 0470-08-FB | Ph 4 | withdrawn | Improving Function, Quality of Life, Glycemia in Diabetics With Dementia |
| NCT03781752 | GCO 17-0281 1R01HD093612-01A1 | Ph 4 | recruiting | Carboxylesterase 1 Genetic Variation and Methylphenidate in ADHD |
| NCT03781765 MPH-ATX | GCO 17-0423 1R21DA045218-01A1 | Ph 4 | recruiting | Stimulant vs. Non-stimulant Treatments and Reward Processing in Drug-naive Youth at SUD Risk |
| NCT04273880 | H13-00286 5R01DA037285-05 | Ph 1 | recruiting | Differences by Sex and Genotype in the Effects of Stress on Executive Functions |
| NCT05669924 | STU00213557 | Ph 2 | completed | Neural Correlates of Acute Pain Dynamics |
| NCT06077669 | IRB00408678 | Ph 4 | withdrawn | Multimodal Brain Imaging of Methylphenidate in Children and Adolescents With ADHD |
| NCT00754208 results posted | 0380-08-FB | Ph 4 | completed | Long Acting Stimulant Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Young Children |
| NCT02346201 ADMET2 results posted | ADMET2 R01AG046543 | Ph 3 | completed | Apathy in Dementia Methylphenidate Trial 2 |
| NCT02477280 | 2015-03-10/11 2014-001488-11 | Ph 4 | completed | Effects of Expectation, Medication and Placebo on Objective and Self-rated Performance |
| NCT02153944 results posted | 140114 14-M-0114 | Ph 4 | completed | Cognitive vs. Emotional Psychopharmacological Manipulations of Fear vs. Anxiety |
| NCT02502799 results posted | DA034731 | Ph 3 | terminated | Intervention for Teens With ADHD and Substance Use |
| NCT01978431 | 1001006250 R25MH071584 | Ph 1 | completed | Impulsivity and Stimulant Administration |
| NCT04178993 results posted | BED(IN):40 R01DA047391 | Ph 1 | completed | Behavioral Effects of Drugs (Inpatient): 40 [Methamphetamine, Methylphenidate, Duloxetine] |
| NCT05669170 MAV-PD | CX002673-01 | Ph 2 | not yet recruiting | Methylphenidate for Apathy in Veterans With Parkinson's Disease |
| NCT03481959 METHACAN | P140313 | Ph 3 | terminated | Effectiveness of Methylphenidate Late Formula to Reduce Cannabis Use in Young Cannabis-Related Patients and Attention Deficit Disorder Hyperactivity |
| NCT02700685 | Pycno 2015-14 | Ph 3 | completed | Effect of Pycnogenol® on ADHD |
| NCT04349917 results posted | 16-0112 R00MH102349 | Ph 4 | completed | Large-scale Brain Organization During Cognitive Control in ADHD |
| NCT03185065 TRIUMPHANT-MS results posted | IRB00119702 | Ph 3 | completed | Treatment of Fatigue With Methylphenidate, Modafinil and Amantadine in Multiple Sclerosis |
| NCT02807870 | 466859/2014-7 | Ph 4 | completed | Early Interventions in Children With Attention Deficit/Hyperactivity Disorder |
| NCT02039908 results posted | MH099030 | Ph 4 | completed | Examining Tolerance to CNS Stimulants in ADHD |
| NCT01933217 results posted | 1K23HD074683-01A1 | Ph 4 | completed | Methylphenidate for Attention Problems After Pediatric TBI |
| NCT02063945 | SHEBA-13-0564-DG-CTIL | Ph 4 | terminated | Methylphenidate vs. Risperidone for the Treatment of Children and Adolescents With ADHD and Disruptive Disorders |
| NCT02225106 DAPET-TBI results posted | 140169 14-N-0169 | Ph 2 | completed | Dopamine Receptor Imaging to Predict Response to Stimulant Therapy in Chronic TBI |
| NCT02051452 results posted | 2013P001114 | Ph 1, Ph 2 | completed | Reversal of General Anesthesia With Methylphenidate |
| NCT01164956 results posted | 10-146 | Ph 1 | terminated | Methylphenidate for Cancer-Related Fatigue |
| NCT02227056 | loe130007ctil | Ph 2 | completed | Effect of Methylphenidate on Ecologic Function in Paediatric Acquired Brain Injury Population |
| NCT02148783 | 402693-1 HJF grant | Ph 2 | terminated | Dopamine Receptor Imaging to Predict Response to Stimulant Therapy in Chronic TBI |
| NCT02675400 | Fathers Too | Ph 4 | completed | Treatments for Fathers With ADHD and Their At-Risk Children (Fathers Too) |
| NCT02473185 | 2015-03-10/53 2014-005045-53 | Ph 4 | completed | Effects of Expectation, Medication and Placebo on Objective and Self-rated Performance During the QbTest |
Showing 50 of 78 trials
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.
COTEMPLA XR-ODT FDA Label Details
Indications & Usage
FDA Label (PDF)COTEMPLA XR-ODT is indicated for the treatment of Attention Deficit Hyperactivity Disorder.
WARNING: ABUSE, MISUSE, AND ADDICTION COTEMPLA XR-ODT has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including COTEMPLA XR-ODT, can result in overdose and death (5.1, 9.2, 10). Before ...
COTEMPLA XR-ODT Patents & Exclusivity
Patents (4 active)
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Revenue Insights
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Patent Timeline
- • Cliff: 2038
- • 48 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.