NDAORALTABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE
Approved
Jun 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
COTEMPLA XR-ODT (methylphenidate) by Therapeutic Solutions International is (cns) stimulant. First approved in 2017.
Drug data last refreshed 1h ago · AI intelligence enriched 6d 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 approved in 2017 for ADHD. The mechanism of therapeutic action in ADHD is not fully understood, but the drug works as a central nervous system stimulant. The ODT (orally disintegrating tablet) format offers a patient convenience advantage over standard tablets.
$0.237MPart D
Peak11.3 years to LOEThe product is in peak lifecycle stage with modest Part D spending ($237K in 2023), suggesting a small but stable patient base; commercial teams likely remain lean relative to blockbuster franchises.
Mechanism of Action
(CNS) stimulant. The mode of therapeutic action in ADHD is not known.
Pharmacologic Class:
Central Nervous System Stimulant
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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.