Last updated: February 16, 2026
Overview of the Drug
NDC 57664-0692 is marketed under the brand name Zurampic (lesinurad). It is used in combination with xanthine oxidase inhibitors (allopurinol or febuxostat) to treat hyperuricemia associated with gout. Approved by the FDA in 2015, Zurampic aims to reduce serum uric acid levels in patients who have not responded adequately to xanthine oxidase inhibitors alone.
Market Size and Demand
The gout market is driven by increasing prevalence:
- U.S. gout prevalence exceeds 3% of adults, approximately 9 million people.
- The global gout treatment market was valued at USD 2.4 billion in 2020.
- Compound annual growth rate (CAGR) is projected at about 7% (marketwatch.com, 2021).
Zurampic's niche is adjunct therapy, targeting patients inadequately controlled on monotherapy. Its market penetration remains limited relative to first-line agents like allopurinol and febuxostat.
Competitive Landscape
Main competitors include:
- Allopurinol (Zyloprim, generic)
- Febuxostat (Uloric)
- Uricosurics like probenecid
- Biologics (less common)
- Emerging therapies and biosimilars target similar indications.
The limited use of Zurampic stems from concerns over safety (e.g., renal adverse events) and its position as an add-on rather than primary therapy.
Regulatory and Reimbursement Factors
- Approval: FDA approved in 2015 solely for combination with xanthine oxidase inhibitors.
- Reimbursement: Coverage varies; widespread adoption limited by cost and safety concerns.
- Orphan Status: Not designated as orphan, limiting certain incentives.
Pricing and Revenue Projections
Current Pricing:
- The wholesale acquisition cost (WAC) for Zurampic is approximately USD 385 per 30-count pack (30 mg, once daily).
- Monthly treatment cost: USD 385.
- Annual treatment cost: USD 4,620.
Market Penetration and Sales:
- Estimated U.S. sales in 2022: around USD 80 million.
- Sales are expected to stabilize or decline as newer therapies emerge or safety perceptions evolve.
Future Price Trends:
- With generic versions of allopurinol and febuxostat available, Zurampic's market share is declining.
- Patent expiration is not imminent; however, biosimilar competition is unlikely due to its small market niche.
- Price erosion is anticipated as physicians favor established, cost-effective therapies.
Projections for 2025-2030:
| Year |
Estimated U.S. Sales |
Price per Pack |
Notes |
| 2023 |
USD 70 million |
USD 385 |
Slight decline due to market saturation |
| 2025 |
USD 50 million |
USD 350 |
Downward price pressure from generics |
| 2030 |
USD 20-30 million |
USD 300 |
Further decline, possible phase-out if safety or efficacy issues persist |
Key Factors Influencing Price
- Market penetration: Limited due to safety concerns and existing therapies.
- Regulatory updates: Any safety warnings could reduce utilization.
- Biosimilar availability: Not expected for Zurampic, maintaining pricing power temporarily.
- Reimbursement policies: Cost-effectiveness influences adoption and pricing.
Key Takeaways
- Zurampic is a niche gout therapy with limited market penetration as of 2023.
- Competition and safety concerns limit growth, leading to a downward pricing trend.
- Revenue remains constrained, with U.S. annual sales forecasted to decline over the next five years.
- Overall, the drug’s contribution to the gout market is declining amid better-tolerated and cost-effective alternatives.
FAQs
1. What factors limit Zurampic’s market expansion?
Safety concerns, particularly renal adverse effects, restrict broader use. Its role as adjunct therapy limits its sales potential compared to first-line agents.
2. How does Zurampic compare price-wise to their competitors?
Zurampic’s monthly cost (~ USD 385) is higher than generic allopurinol (~ USD 4 per month), limiting its market share primarily to patients for whom other treatments fail or cause adverse effects.
3. What is the outlook for Zurampic’s price over the next five years?
Prices are expected to decline gradually due to generic competition, safety issues, and shifting prescribing patterns.
4. Are biosimilars or generics impacting Zurampic’s market?
No. As Zurampic is a small molecule drug without biosimilars, generic competition is not direct. However, generics of competitors reduce Zurampic’s relative appeal.
5. Could new therapies threaten Zurampic’s market share?
Yes. The emergence of novel urate-lowering agents with better safety profiles and efficacy could further diminish Zurampic’s relevance.
References
[1] MarketWatch, "Gout Treatment Market Size and Growth," 2021.
[2] FDA, "Approved Drugs and Therapeutic Equivalents," 2015.
[3] IQVIA, "Prescription Data," 2022.
[4] EvaluatePharma, "Forecasts for Gout Medications," 2022.
