NDAINJECTIONINJECTABLEPriority Review
Approved
May 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
ALOPRIM (allopurinol) by Viatris (2) is base, hypoxanthine. First approved in 1996.
Drug data last refreshed 28m ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ALOPRIM (allopurinol) is an injectable xanthine oxidase inhibitor approved in 1996 for the management of hyperuricemia and gout. It works by blocking the enzyme responsible for converting hypoxanthine and xanthine to uric acid, thereby reducing serum and urinary uric acid levels without disrupting purine biosynthesis. The IV formulation serves patients unable to tolerate or absorb oral allopurinol.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30/100), indicating a mature portfolio requiring defensive positioning and cost optimization strategies.
Mechanism of Action
base, hypoxanthine. Allopurinol and its oxypurinol metabolite inhibitor xanthine oxidase, the enzyme responsible for the conversion of hypoxanthine to xanthine and of xanthine to uric acid, the end product of purine metabolism in humans. Allopurinol does not disrupt the biosynthesis of purines. The…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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.