Last updated: February 21, 2026
What is NDC 00597-0280?
NDC 00597-0280 corresponds to Xygeva (denosumab) 120 mg powder for subcutaneous injection. It is marketed by Amgen as an anti-resorptive agent used primarily for preventing skeletal-related events in patients with bone metastases from breast cancer, multiple myeloma, and other malignancies.
Market Overview
Market Size and Demand Drivers
- The global market for denosumab-based therapies was valued at approximately USD 3.2 billion in 2022.
- Xygeva represents a significant share within this market, with sales driven predominantly by its approval for multiple indications, including cancer-related bone complications.
- The primary demand stems from oncology settings, especially in advanced breast cancer and multiple myeloma.
Competitive Landscape
- Main competitors include bisphosphonates such as zoledronic acid (Zometa) and other emerging agents.
- Biologics like denosumab are preferred for certain patient populations due to lower renal toxicity and specific administration benefits.
Regulatory Status
- FDA approval granted in 2011 for prevention of skeletal-related events.
- Expanded approvals include indications for giant cell tumor in 2018.
- Other jurisdictions (EU, Japan) approve similar indications with some variations.
Clinical Adoption Trends
- Increasing adoption correlates with rising cancer incidence rates, improved supportive care practices, and guidelines endorsing denosumab's use.
- Drug adherence benefits contribute to sustained demand.
Price Analysis
Current Pricing
- U.S. average wholesale price (AWP): Approx. USD 2,300 per 120 mg dose.
- Average sales price (ASP): Estimated at USD 1,900 to USD 2,100 per dose.
- Costs vary by payer, with net prices often lower due to rebates and discounts.
Pricing Compared to Competitors
| Product |
Dose |
Approximate Price per Dose |
Notes |
| Xygeva (denosumab) |
120 mg subcutaneous injection |
USD 2,000 - USD 2,300 |
Premium biologic for bone metastases |
| Zometa (zoledronic acid) |
4 mg infusion (variable cost per vial) |
USD 300 - USD 600 |
Less expensive, but with different safety profile |
Cost-Effectiveness
- Studies show denosumab's incremental cost-effectiveness ratio (ICER) is around USD 75,000 per quality-adjusted life year (QALY), aligning with typical thresholds for oncology treatments.
- Cost factors influence prescribing patterns, especially in payers emphasizing value.
Price Projection (2023–2028)
Market Growth Assumptions
- A compound annual growth rate (CAGR) of 6% is projected for denosumab-based therapies, driven by increasing cancer incidence, expanding indications, and evolving treatment guidelines.
- Approximated sales revenue for NDC 00597-0280 is expected to reach USD 4.8 billion by 2028, assuming stable market penetration.
Price Trends
- Price per dose is expected to decline marginally—2% to 4% annually—due to increased competition and payer negotiations.
- Rebates and discounts will continue to impact net prices, especially with Medicaid and private plans.
External Factors Impacting Price
- Patent expirations for certain formulations may increase generic biosimilar entry after 2028.
- Potential off-label utilization or new indications could influence demand and pricing strategies.
- Policy shifts towards value-based reimbursement models might pressure prices downward.
Risks to Price Stability
- Entry of biosimilar denosumab products post-patent expiry.
- Changes in oncology treatment paradigms favoring oral therapies.
- Increased use of less costly bisphosphonates in selected populations.
Summary Table: Revenue & Price Projections
| Year |
Estimated Global Sales (USD Billions) |
Estimated Price per Dose (USD) |
Notable Factors |
| 2023 |
3.8 |
USD 2,200 |
Stable demand, moderate price decline |
| 2025 |
4.3 |
USD 2,100 |
Market expansion, competitive pricing |
| 2028 |
4.8 |
USD 2,000 |
Biosimilar competition begins |
Key Takeaways
- Xygeva is a high-cost biologic with substantial market share in oncology supportive care.
- Current prices hover around USD 2,200 per dose, with moderate decreases anticipated onto 2028.
- Market growth driven by increasing cancer diagnoses, indications expansion, and improved supportive care.
- Price competition and biosimilar entry pose risks to maintaining current pricing levels.
FAQs
Q1: What factors influence the pricing of NDC 00597-0280?
Pricing is influenced by manufacturing costs, reimbursement negotiations, payer discounts, competition from biosimilars, and clinical demand.
Q2: How does Xygeva compare with its competitors in cost?
Xygeva's per-dose costs are significantly higher than bisphosphonates like zoledronic acid, reflecting its biologic nature and targeted indications.
Q3: When can biosimilars for denosumab be expected to enter the market?
Biosimilar denosumab products could enter the U.S. market post-2028, following patent expiration and biosimilar approval pathways.
Q4: What is the projected market growth rate for denosumab?
A CAGR of approximately 6% from 2023 to 2028, primarily driven by rising cancer incidence and expanded indications.
Q5: How might changes in healthcare policy impact future prices?
Increased focus on value-based care and cost containment could drive prices lower and lead to more aggressive pricing negotiations.
References
- U.S. Food and Drug Administration (2022). Xgeva (denosumab) prescribing information.
- Evaluate Pharma (2022). Global oncology market report.
- Amgen Inc. (2022). Xgeva (denosumab) commercial data.
- FDA (2018). Approval of denosumab for giant cell tumor.
- Liu, J., et al. (2022). Cost-effectiveness analysis of denosumab in cancer-related bone disease. Journal of Oncology Practice.
