ULTRAM
LOE ApproachingNDAORALTABLET
Approved
Mar 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
6
Data completeness
2/8 — Basic
Drug data last refreshed 5h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ULTRAM is an oral tablet small-molecule analgesic approved in 1995 by Johnson & Johnson. The mechanism of action and specific indications are not documented in available data, limiting characterization of its therapeutic positioning. As an NDA-approved product now approaching loss of exclusivity, it represents a mature franchise in pharmaceutical portfolios.
LOE Approaching
Moderate competitive pressure (30/100) suggests the product faces headwinds; commercial teams should anticipate headcount rationalization or transition to LOE-defensive strategies.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (6)
Micronized and Ultramicronized Palmitoylethanolamide in Fibromyalgia Patients
Started Jul 2020
21 enrolled
Fibromyalgia
Pembrolizumab in Ultramutated and Hypermutated Endometrial Cancer
Started Sep 2016
25 enrolled
Recurrent Endometrial Cancer
A Pharmacokinetic Study to Evaluate the Dose-Proportionality of Tramadol (ULTRAM) Extended-Release (ER) in Healthy Participants
Started Jul 2011
30 enrolled
Healthy
A Study of ULTRAM ER at Two Dose Levels in Adolescents With Pain
Started Oct 2007
38 enrolled
Pain
A Pharmacokinetic, Tolerability, and Safety Study of ULTRAM ER in Children With Pain
Started Oct 2007
37 enrolled
Pain
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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.