Last updated: February 27, 2026
What is NDC 59676-0562?
NDC 59676-0562 refers to Urate Oxidase (Rasburicase), a recombinant enzyme used primarily in oncology for managing tumor lysis syndrome (TLS). The drug is marketed under trade names such as Elitek and primarily manufactured by Sanofi. It is administered intravenously to reduce uric acid levels in patients undergoing chemotherapy.
Market Overview
Market Size and Demand Drivers
The global uricase market, driven mostly by the oncology segment, was valued at approximately USD 150 million in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 8% through 2028. The growth is fueled by increasing adoption in oncology protocols, rising incidence of cancers associated with TLS, and expanding clinical indications.
Key Indications
- Tumor lysis syndrome (TLS)
- Hyperuricemia due to cancer treatments
- Certain hyperuricemic gout cases (less common)
Competitive Landscape
Major competitors include:
- Sanofi (Elitek)
- CytRx Corporation (early-stage products)
- Novel bioengineered formulations in development for extended half-life
Sanofi’s monopolistic position stems from patent protections and established distribution channels.
Patent and Regulatory Status
The original patent for Rasburicase expired in 2022 globally, opening market access for biosimilars, which anticipate contesting the pricing landscape. FDA approval remains active for existing formulations, with biosimilar applications under review or awaiting approval.
Reimbursement Landscape
Reimbursement policies vary by region but generally favor established therapies like Elitek. Payers review cost-effectiveness based on clinical efficacy and safety data.
Price Analysis
Current Pricing
- Brand Name (Elitek): List price per vial (5 mg) ranges between USD 1,000 and USD 2,000.
- Average Wholesale Price (AWP): Approximately USD 1,800 per 5 mg vial.
- Patient Out-of-Pocket: Varies but can reach USD 500–USD 2,000 depending on insurance.
Market Trends Impacting Price
- Patent expiration in 2022 has led to biosimilar entry, causing price erosion.
- Negotiated discounts and rebates reduce average net prices by 20–30% for payers.
- Manufacturing costs for biosimilars will influence future pricing strategies.
Biosimilar Price Projections (Post-2023)
Assuming biosimilar entry, projected prices per vial are:
| Year |
Estimated Price Range (USD) |
Key Assumptions |
| 2023 |
USD 700 – USD 1,200 |
Entry of biosimilars, initial market uptake |
| 2025 |
USD 500 – USD 900 |
Increased biosimilar competition, cost-driven price drops |
| 2028 |
USD 300 – USD 700 |
Market consolidation, further discounts |
Revenue Projections
Total annual revenue for the branded product is approximately USD 150 million, declining as biosimilars penetrate the market. Biosimilar sales could capture 50% of market share within five years, reducing the overall market value to roughly USD 75 million.
Regulatory and Market Risks
- Delays in biosimilar approval could sustain higher prices for the original product.
- Pricing pressures from payers and government agencies.
- Clinical trial outcomes for biosimilar efficacy and safety.
Strategic Implications
Investments in biosimilar development are poised to intensify. Companies with manufacturing efficiencies and established distribution will capture pricing advantages.
Key Takeaways
- NDC 59676-0562 is a high-value biologic with a market of roughly USD 150 million, primarily driven by oncology applications.
- Patent expiry in 2022 has introduced biosimilar competition, causing downward pressure on prices.
- Current branded prices (~USD 1,800 per vial) are expected to decline by 2028 to USD 300–USD 700.
- Competition will increase access, but future revenue for Sanofi and other innovators will diminish unless new indications or formulations emerge.
- The regulatory landscape remains critical; approval of biosimilars will accelerate price erosion.
Frequently Asked Questions
1. How early can biosimilars enter the market for Rasburicase?
Biosimilar applications have been submitted, with FDA approvals anticipated within 1–2 years depending on review timelines.
2. What percentage of the market could biosimilars capture?
Potentially up to 50% within five years, contingent on pricing, clinical acceptance, and payer policies.
3. How does biosimilar pricing compare to brand-name Rasburicase?
Biosimilars are projected to be priced 50–80% lower, with initial prices around USD 700–USD 1,200 per vial.
4. What are the main factors influencing future prices?
Market competition, manufacturing costs, regulatory changes, and reimbursement negotiations.
5. Are there new formulations or indications in development?
Research is ongoing into extended half-life formulations and alternative indications such as hyperuricemia beyond oncology.
References
- MarketWatch. (2023). Uricase market size, share, growth, future trends — forecast to 2028. Retrieved from [URL].
- FDA. (2022). Approved biosimilar products: List. Retrieved from [URL].
- IQVIA. (2022). US Oncology Market Analysis. Retrieved from [URL].
- Sanofi. (2022). Elitek prescribing information. Retrieved from [URL].
- BioWorld. (2022). Biosimilar developments in rasburicase. Retrieved from [URL].
