NDAORALTABLET1 Generic Approved
Approved
Feb 2009
Lifecycle
Peak
Competitive Pressure
15/100
Clinical Trials
26
Data completeness
6/8 — Strong
ULORIC (febuxostat) by Takeda is xanthine oxidase inhibitors [moa]. Approved for xanthine oxidase inhibitor [epc]. First approved in 2009.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ULORIC (febuxostat) is an oral xanthine oxidase inhibitor approved in 2009 for the chronic management of hyperuricemia in patients with gout. It works by selectively inhibiting xanthine oxidase, the enzyme responsible for uric acid production, thereby reducing serum urate levels. The drug is indicated for patients who cannot tolerate allopurinol or require alternative urate-lowering therapy.
$6MPart D
Peak5.3 years to LOEPeak-stage product with moderate Part D utilization indicates stable commercial performance but limited team expansion opportunities.
Mechanism of Action
Xanthine Oxidase Inhibitors
Pharmacologic Class:
Xanthine Oxidase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (26)
Tigulixostat (IBI128) vs Febuxostat in Gout
Started Mar 2026
600 enrolled
Gout
Febuxostat 80 mg Tablets Relative to Feburic® 80 mg Tablets
Started Sep 2024
46 enrolled
Healthy Subjects
A Therapeutic Confirmatory Study of Epaminurad Versus Febuxostat in Gout Patients
Started Mar 2023
612 enrolled
Gout
A Study to Evaluate Efficacy of Dotinurad and Febuxostat for the Treatment of Participants With Gout
Started Dec 2021
451 enrolled
Gout
Drug Use Study of Febuxostat After Recent Changes in the Prescribing Information
Started Aug 2020
24,046 enrolled
GoutCardiovascular Diseases
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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.