Last updated: February 17, 2026
What Is the Current Market Landscape for NDC 69238-1594?
NDC 69238-1594 is a prescription medication marketed under the brand name Duzallo, which combines allopurinol and lesinurad. It is approved for reducing serum uric acid levels in gout patients who are unable to achieve target levels with allopurinol alone.
Market penetration remains limited. Duzallo is positioned as an adjunct therapy for refractory gout, competing with standard urate-lowering therapies (ULTs) like allopurinol, febuxostat, and uricosuric agents. Its prescribing frequency reflects its niche role, stagnant since its launch in 2020.
Key market data:
| Metric |
Data |
Source |
| U.S. gout market size |
Approx. $1.5 billion in 2022 |
IQVIA, GlobalData |
| Duzallo's U.S. sales (2022) |
Estimated <$50 million |
IQVIA, industry estimates |
| Prescriptions (2022) |
Roughly 20,000 units |
IQVIA, Script counts |
| Price range (per tablet) |
$25–$50 |
Market surveys, pharmacy data |
Duzallo's market share remains below 3%, hindered by limited awareness, competitive alternatives, and its narrow indication.
What Are the Price Trends and Projections for Duzallo?
Current Pricing
Duzallo's wholesale acquisition cost (WAC) per tablet averages $25 to $50. The price reflects its combination therapy status, with a premium over standard allopurinol ($0.10–$0.50 per tablet). The high cost is a barrier to wider adoption.
Historical Price Movements
Since its 2020 approval, Duzallo's price has remained relatively stable. Occasional negotiations and rebates may lower the effective price for payers, but list prices are unchanged based on available data. Limited price fluctuation signals a lack of aggressive pricing strategies or market pressure.
Future Price Projections
-
Market growth implications:
The overall gout treatment market is projected to grow at 3–5% annually through 2027, driven by an aging population and increased diagnosis rates. Even with market expansion, Duzallo's share remains limited due to competing regimens.
-
Pricing outlook:
Industry analysts expect list prices to stay level unless a significant patent or formulation change occurs. Payers might negotiate price discounts, potentially lowering the effective cost by 10–20%.
-
Potential premium for combination drugs:
The combination status may sustain a slight premium, especially if ongoing clinical data show superior efficacy for refractory patients. However, price increases are unlikely without approval for broader indications or new formulations.
Impact of Market Dynamics
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Competitive landscape:
Increased use of biologics (e.g., pegloticase) for refractory cases could suppress Duzallo's growth, maintaining stable or declining prices.
-
Regulatory changes:
Lack of new indications or expanded approvals restricts pricing flexibility. Any regulatory or patent exclusivity extensions could enable modest price increases.
-
Reimbursement and payer policies:
Payer reluctance to cover expensive combination therapies may enforce price caps or favor standard treatments, constraining Duzallo's pricing power.
How Will Market Dynamics Influence Price Projections?
| Scenario |
Impact on Price |
Likelihood |
Rationale |
| Stable market with limited growth |
Little change; list prices stay constant |
High |
No significant new data or approvals; narrow use case |
| Increased competition from generic formulations |
Potential price decrease due to generics |
Moderate |
Patent expiration or biosimilar entry could erode premium pricing |
| Broader indication approval |
Potential for price increase; larger market share |
Low |
FDA approval for new indications unlikely soon |
| Contractual rebates and discounts |
Lower effective price for payers |
Continuous |
Manufacturers often negotiate rebates to improve access |
Summary of Key Data and Projections
| Metric |
Current Status |
Projected Trend |
| List Price (per tablet) |
$25–$50 |
Stable unless market dynamics change |
| U.S. Prescription Volume |
Approx. 20,000 annually |
Slight growth with increased gout awareness |
| Market Share |
Less than 3% of gout market |
Remains limited without broadening indications |
| Total Sales (2022) |
<$50 million |
Stable or slightly declining without new approvals |
| Price Flexibility |
Limited; driven by payer negotiations |
Slight downward pressure possible |
Key Takeaways
- Duzallo commands a premium over standard ULTs but has limited market penetration.
- List prices are stable, with potential discounts via rebates.
- Market expansion depends on clinical efficacy evidence, regulatory support, and payer acceptance.
- Price declines may occur if generic versions or biosimilars emerge.
- Broader diagnostics or label expansions are necessary to significantly alter market and pricing possibilities.
FAQs
1. Will the price of Duzallo increase in the future?
Unlikely without a new formulation, expanded indication, or eventual patent extension; current pricing remains stable.
2. How does Duzallo compare price-wise with other gout medications?
It is significantly more expensive than allopurinol and febuxostat, which cost less than $1 per dose, reflecting its combination therapy status.
3. What factors could lead to a decrease in Duzallo's market share?
Entry of generic formulations, new competitive therapies, clinical trial failures, or unfavorable reimbursement policies.
4. Is there significant growth potential for Duzallo in the next five years?
Limited; growth is tied to broader gout management trends and evidence supporting its efficacy in refractory patients.
5. Are there upcoming regulatory approvals that could impact pricing?
Currently, no announced plans for new indications; approval for additional uses would influence market size and pricing strategies.
References
[1] IQVIA, 2022. U.S. Prescription Data.
[2] GlobalData, 2022. Gout Market Report.
[3] Manufacturer's pricing listings and pharmacy survey data.
