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 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ULTRACET is a fixed-dose combination tablet containing tramadol (37.5 mg) and acetaminophen (325 mg) for oral pain management. It is a centrally acting synthetic opioid analgesic that works through dual mechanisms: mu-opioid receptor binding and inhibition of norepinephrine/serotonin reuptake. The drug is indicated for osteoarthritis and moderate pain relief.
LOE Approaching
Product is nearing loss of exclusivity with moderate competitive pressure (30/100), signaling potential team consolidation and shift toward generic defense 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 (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.