NDAORALTABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE
Approved
Jun 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
7/8 — Comprehensive
COTEMPLA XR-ODT (methylphenidate) by Therapeutic Solutions International is (cns) stimulant. Approved for attention deficit hyperactivity disorder. First approved in 2017.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
COTEMPLA XR-ODT is an orally disintegrating extended-release tablet formulation of methylphenidate, a CNS stimulant indicated for ADHD and off-label use in depression, fatigue, and neurodegenerative conditions. The mechanism of therapeutic action in ADHD remains unknown, though it functions as a CNS stimulant. The product addresses dosing convenience through its orally disintegrating formulation for patients with swallowing difficulties.
$237KPart D
Peak11.7 years to LOEMinimal commercial scale with $237K Part D spending and 294 claims in 2023 suggests a niche product with limited team infrastructure and growth potential.
Mechanism of Action
(CNS) stimulant. The mode of therapeutic action in ADHD is not known.
Pharmacologic Class:
Central Nervous System Stimulant
Indications (1)
Clinical Trials (20)
Methylphenidate for Apathy in Veterans With Parkinson's Disease
Started Jan 2024
60 enrolled
Parkinson DiseaseApathy
A Study on Suicidality, Psychosis or Substance Abuse With Methylphenidate, Atomoxetine, Amphetamine/Dextroamphetamine or Lisdexamfetamine
Started Oct 2019
430,000 enrolled
Attention Deficit Disorder With Hyperactivity
A 14 Week, Randomized, Placebo-Controlled Cross-Over Study of Methylphenidate Hydrochloride Controlled Release Capsules in Adult ADHD With and Without Anxiety Disorder Comorbidity
Started Apr 2019
60 enrolled
Attention Deficit Hyperactivity DisorderGeneralized Anxiety DisorderSocial Anxiety Disorder+2 more
Safety, Tolerability and PK Study of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD.
Started Sep 2018
0Attention Deficit Hyperactivity Disorder (ADHD)
A 6-week Study to Evaluate the Safety and Efficacy of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD
Started Sep 2018
0Attention Deficit Hyperactivity Disorder
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.