NDAORALTABLET
Approved
Sep 1984
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
ALLOPURINOL (allopurinol) by Teva is xanthine oxidase inhibitors [moa]. Approved for gout, hyperuricemia. First approved in 1984.
Drug data last refreshed 19h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Allopurinol is an oral xanthine oxidase inhibitor approved in 1984 for treating gout and hyperuricemia by reducing serum uric acid production. It works by inhibiting the enzyme xanthine oxidase, which catalyzes the final steps of purine metabolism, thereby lowering uric acid levels in the blood and urine.
LOE Approaching
With LOE approaching and modest annual spending of $15M, the brand team is likely in consolidation mode focused on defending market share against generic erosion and newer therapeutic alternatives.
Mechanism of Action
Xanthine Oxidase Inhibitors
Pharmacologic Class:
Xanthine Oxidase Inhibitor
Indications (2)
Clinical Trials (20)
A Study of Dotinurad Versus Allopurinol in Tophaceous Gout
Started Aug 2025
250 enrolled
Tophaceous Gout
A Study of Dotinurad Versus Allopurinol in Participants With Gout
Started Aug 2025
500 enrolled
Gout
Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients with Hyperuricemia
Started Oct 2023
20 enrolled
GoutHyperuricemia
Phase II Study to Evaluate Efficacy and Safety of D-0120 in Combination With Allopurinol in Subjects With Gout
Started Apr 2023
80 enrolled
Gout
Phase 2 to Assess Efficacy and Safety in AR882 Alone or in Combination With Allopurinol in Patients With Tophaceous Gout
Started Aug 2022
42 enrolled
GoutArthritis, GoutyHyperuricemia+1 more
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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.