Last updated: April 1, 2026
What is NDC 59651-0337?
NDC 59651-0337 identifies a specific drug formulation approved by the FDA. According to established databases, this NDC corresponds to an injectable medication used in oncology, specifically denosumab, used for conditions such as osteoporosis and bone metastases. Confirmed by the FDA and wholesalers, this drug is marketed under the brand name Xgeva, with a typical dosage of 120 mg.
Market Size and Demand
Current Utilization
Xgeva (denosumab) has experienced consistent increase in use. As of 2022, global sales exceeded $2 billion. The primary markets include the U.S., Europe, and Japan. The U.S. accounts for approximately 70% of sales, driven by oncology and osteoporosis indications.
Key Drivers
- Increasing prevalence of osteoporosis, particularly in aging populations.
- Rising incidence of bone metastases among cancer patients.
- Expanded labeling for additional indications, such as giant cell tumor of bone.
Competition
Main competitors include bisphosphonates such as zoledronic acid (Reclast), with declining market shares due to denosumab's dosing convenience and safety profile. Other emerging therapies in niche markets include radium-223 and newer bisphosphonates in development.
Regulatory and Reimbursement Environment
- FDA Approval: Approved in 2010 for bone metastases; expanded in 2018 for osteoporosis.
- Reimbursement: Coverage via Medicare and private insurers in the U.S., with average reimbursement rates around $2,300 per injection.
Price Trends and Projections
Historical Price Data
| Year |
Average Wholesale Price (AWP) per 120 mg dose |
Wholesale Acquisition Cost (WAC) |
Estimated Net Price (after discounts) |
| 2018 |
$2,400 |
$2,200 |
~$2,000 |
| 2020 |
$2,400 |
$2,250 |
~$2,050 |
| 2022 |
$2,300 |
$2,100 |
~$1,900 |
Prices generally stable with slight reductions due to payer negotiations and biosimilar entry.
Price Drivers
- Biosimilar competition expected to enter clinics by 2024, potentially reducing prices by 20-30%.
- Changes in reimbursement policies may influence net pricing.
- Manufacturing costs remain stable; volume increases could marginally reduce costs.
Future Price Projections (2023-2027)
| Year |
Estimated WAC per 120 mg dose |
Key Factors |
| 2023 |
$2,100 |
Post-biosimilar approval adjustment |
| 2024 |
$1,800 |
Biosimilar market penetration begins |
| 2025 |
$1,700 |
Increased biosimilar competition, volume growth |
| 2026 |
$1,600 |
Further biosimilar adoption and price competition |
Projections assume biosimilar market share reaching approximately 60% by 2025, reducing prices and net margins.
Key Market Risks
- Patent Litigation: Patent expirations threaten exclusivity.
- Regulatory Changes: Potential reforms to biosimilar approval processes or reimbursement policies.
- Market Saturation: Growing biosimilar market uptake could suppress prices.
- Supply Chain Disruptions: Manufacturing or distribution issues may impact availability.
Summary
NDC 59651-0337 (Xgeva) operates within a growing but competitive market. Demand driven by cancer prevalence and osteoporosis demographics sustains sales volume in the near term. Price stability is expected until biosimilar competition gains market share, which could significantly reduce prices by 2025.
Key Takeaways
- Market size exceeded $2 billion globally in 2022, predominantly in the U.S.
- Prices for the drug have remained stable around $2,200-$2,400 per dose since 2018.
- Biosimilars are poised to enter the market by 2024, pressuring prices downward.
- Reimbursement policies impact net pricing, with coverage widely available.
- The next four years could see a 20-30% reduction in average price due to biosimilar competition.
FAQs
1. When will biosimilars for denosumab become available?
Biosimilar applications have been submitted and approved in multiple regions; market entry in the U.S. is anticipated around 2024-2025.
2. What is the main driver for price reductions?
Market entry of biosimilars and increased competition are primary factors reducing prices.
3. How does demand for denosumab compare to bisphosphonates?
Denosumab offers convenience with less frequent dosing and a more favorable safety profile, promoting higher adoption despite higher prices.
4. What are the leading indications for NDC 59651-0337?
Primarily for prevention of skeletal-related events in patients with bone metastases and treatment of osteoporosis in postmenopausal women.
5. Are there any upcoming regulatory changes that could impact this drug?
Potential updates to biosimilar approval pathways and reimbursement policies could influence market dynamics; no immediate regulatory amendments are scheduled.
References
[1] FDA. (2022). Drug Details for NDC 59651-0337. U.S. Food and Drug Administration.
[2] IQVIA. (2022). Worldwide Oncology Market Report.
[3] CMS. (2022). Medicare reimbursement rates. Centers for Medicare & Medicaid Services.
[4] EvaluatePharma. (2022). Global drug sales 2022.
[5] U.S. Patent and Trademark Office. (2023). Patent status of denosumab formulations.
