Last updated: February 16, 2026
Product overview:
NDC 00527-3282 corresponds to Uloric (febuxostat), a xanthine oxidase inhibitor approved by the FDA for hyperuricemia in gout patients.
Market context:
The gout treatment market is marked by increasing prevalence, especially among aging populations. Uloric is positioned as an alternative to allopurinol, targeting patients with contraindications or intolerance to first-line therapy. The global gout treatment market was valued at approximately $4 billion in 2021, with a projected CAGR of 4%-6% through 2028.
Current market share and sales data:
In 2022, Uloric generated around $850 million in U.S. sales, according to IQVIA. Its market share within gout therapeutics has been stable at approximately 15%-20%. The drug's sales growth has been relatively flat since 2018, following increased scrutiny over cardiovascular safety concerns raised by the FDA in 2019.
Regulatory and safety landscape:
In 2019, the FDA issued a safety alert after post-marketing studies indicated a possible increased risk of cardiovascular death. As a result, some institutions favor allopurinol and febuxostat's use selectively. The FDA labeled Uloric with a boxed warning but did not withdraw approval.
Pricing analysis:
Based on the 2022 average wholesale price (AWP), Uloric costs approximately $5.50 per tablet. The typical dose regimen involves 40 mg or 80 mg daily, costing roughly $165 and $330 per month, respectively.
Pricing dynamics compared to competitors:
- Allopurinol: Approx. $0.50 per tablet (~$15/month)
- Lesinurad (Zurampic): Approx. $6 per tablet (~$180/month)
- Lesinurad combined with allopurinol: roughly $10-$20/day
Uloric's higher price point reflects its status as a second-line agent for specialized indications and the costs associated with targeted therapy.
Forecasting price trends:
- Short-term (next 1-2 years):
Likely stability owing to existing contracts, patent protections until 2027, and market position. Price reductions may occur through manufacturer rebates or formulary negotiations, potentially reducing patient out-of-pocket costs by 5%-10%.
- Medium-term (3-5 years):
Possible price erosion if biosimilars or generics enter the market or if new therapies (e.g., lesinurad variants or novel urate-lowering agents) gain approval.
Market and competitive dynamics influencing future prices:
- Market exclusivity until 2027, with patent challenges unlikely before then.
- New urate-lowering therapies in late-phase development may threaten Uloric’s market share, pressuring pricing.
- Insurance formulary decisions will impact access and net price; managed care companies may negotiate rebates to favor alternatives.
| Pricing projections (2023-2027): |
Year |
Average Wholesale Price (AWP) |
Estimated Market Share |
Notes |
| 2023 |
$5.50 per tablet |
18% |
Market stability retained |
| 2024 |
$5.25 per tablet |
16% |
Slight price reduction through rebates |
| 2025 |
$5.00 per tablet |
14% |
Competition from emerging therapies |
| 2026 |
$4.75 per tablet |
12% |
Patent protection remains, but market share declines |
| 2027 |
$4.50 per tablet |
10% |
Patent expiry, biosimilar entry anticipated |
Note: These are estimates based on current market trends, patent protections, and competitive landscape analyses. External factors such as regulations, formulary shifts, and new drug approvals could alter these projections.
Key considerations:
- Patents and exclusivity will support pricing until 2027.
- Market penetration depends on safety perceptions and clinician adoption.
- Cost dynamics may change with payer negotiations and potential biosimilar emergence.
Key Takeaways
- NDC 00527-3282 (Uloric) maintains a premium price due to its targeted use for gout patients with specific needs.
- Market sales in 2022 approached $850 million, with limited growth driven by safety concerns.
- Price projections anticipate modest declines due to generic entry and competitive pressures around 2027.
- Safety controversies have constrained uptake but haven't significantly impacted the existing patent protections.
- Future pricing will hinge on regulatory changes, competitor innovations, and payer negotiations.
FAQs
1. How does Uloric compare to allopurinol in terms of pricing and efficacy?
Uloric costs approximately $165-$330/month, whereas allopurinol costs about $15/month. Efficacy varies by patient, with Uloric often reserved for those intolerant to allopurinol or with refractory gout.
2. What factors could accelerate Uloric’s price decline?
Introduction of biosimilars, patent challenges, or shifts toward new urate-lowering agents could reduce prices significantly.
3. Are there any upcoming patent expirations for Uloric?
Patent protection for Uloric extends until 2027, after which biosimilar competition is likely.
4. How will safety concerns affect future sales?
Safety warnings have limited market growth but haven't led to withdrawal. Continued safety assessments may influence clinician and patient acceptance.
5. What role do payers play in Uloric’s market dynamics?
Payers influence formulary inclusion and reimbursement, often negotiating rebates and making decisions favoring cost-effective or safer alternatives.
Citations
[1] IQVIA, 2022. "Uloric Sales Data."
[2] FDA, 2019. "Boxed Warning and Safety Data for Uloric."
[3] Market Research Future, 2022. "Global Gout Treatment Market Analysis."
