ULTRACET
LOE ApproachingNDAORALTABLET
Approved
Aug 2001
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
2/8 — Basic
Drug data last refreshed 12h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ULTRACET is an oral tablet small-molecule analgesic approved in 2001 by Johnson & Johnson. The product is a combination formulation designed for pain management. Specific mechanism of action and indicated conditions are not detailed in available data.
LOE Approaching
Product is in late-stage lifecycle with approaching loss of exclusivity, likely characterized by declining headcount and cost-containment focus on the brand team.
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 (7)
Bioequivalence Study of Tramadol Hydrochloride /Paracetamol Tablets Versus Ultracet Tablets
Started Mar 2019
60 enrolled
Healthy
A Study to Assess the Bioequivalence of a New ULTRACET Extended Release (ER) Tablet With Respect to a Marketed ULTRACET ER Tablet Under Fasted Condition
Started Dec 2012
56 enrolled
Healthy
An Open Label Study to Evaluate Safety, Tolerability and Clinical Utility of ULTRACET® (37.5mg Tramadol Hydrochloride/325mg Acetaminophen) for the Treatment of Breakthrough Pain in Cancer Patients
Started Dec 2005
60 enrolled
Pain
A Study of Safety and Effectiveness of Ultracet in Patients With Chronic Cancer Pain
Started Jul 2004
35 enrolled
Cancer
A Study Comparing the Effectiveness and Safety of ULTRACET® (Tramadol HCl/Acetaminophen) Versus Placebo for the Treatment of Acute Pain From a Migraine Headache
Started Apr 2003
375 enrolled
MigraineHead PainHeadache
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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.