NDAORALTABLET, ORALLY DISINTEGRATING
Approved
May 2005
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
RYBIX ODT (tramadol hydrochloride) by Shionogi is tramadol, an opioid agonist and inhibitor of norepinephrine and serotonin re- uptake. First approved in 2005.
Drug data last refreshed 8h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RYBIX ODT is an orally disintegrating tablet formulation of tramadol hydrochloride, a synthetic opioid agonist that also inhibits norepinephrine and serotonin reuptake. It is indicated for moderate pain management, with analgesic effects beginning within one hour and peaking at 2–3 hours post-administration. The dual mechanism—opioid receptor binding plus monoamine reuptake inhibition—distinguishes tramadol from pure opioid agonists.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30/100), signaling potential headcount rationalization and transition focus toward cost management and generic transition planning.
Mechanism of Action
tramadol, an opioid agonist and inhibitor of norepinephrine and serotonin re- uptake. Although the mode of action is not completely understood, the analgesic effect of tramadol is believed to be due to both binding to μ-opioid receptors and weak inhibition of re-uptake of norepinephrine and…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Study Evaluating Dexketoprofen Trometamol/Tramadol Hydrochloride Analgesic Efficacy in Acute Low Back Pain
Started Sep 2020
538 enrolled
Low Back Pain
Bioequivalence Study of Tramadol Hydrochloride /Paracetamol Tablets Versus Ultracet Tablets
Started Mar 2019
60 enrolled
Healthy
Tramadol Hydrochloride and Dexketoprofen Trometamol for the Oral Treatment of Moderate to Severe Acute Pain Following Removal of Impacted Lower Third Molar
Started Apr 2016
654 enrolled
Acute Pain
Study to Evaluate the Effects of Tramadol Hydrochloride on Cardiac Repolarization in Healthy Participants
Started Dec 2014
68 enrolled
Healthy
A Dose Ranging Escalation Study of Tramadol Hydrochloride in Healthy Volunteers
Started Aug 2013
30 enrolled
Healthy
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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.