Last updated: February 25, 2026
What is the drug associated with NDC 00006-5364?
The National Drug Code (NDC) 00006-5364 corresponds to Prolia (denosumab) 60 mg prefilled syringe. This drug is approved for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures. It is also indicated for bone loss in certain cancer treatments.
Market Overview
Current Market Size
Prolia is a leading biologic treatment for osteoporosis. The global osteoporosis market was valued at approximately USD 8.1 billion in 2022[1]. Prolia holds a significant share, estimated around 20-25% of the osteoporosis treatment market[2].
Competitors
Prolia competes with bisphosphonates such as alendronate and zoledronic acid, as well as other biologic agents like Reclast (zoledronic acid) and even newer agents like romosozumab.
Prescription Trends
In 2022, global prescriptions of Prolia increased by approximately 12%, driven by expanding indications and aging populations in the US, Europe, and Asia-Pacific. U.S. prescriptions accounted for about 55% of total sales[3].
Regulatory Status
Prolia received FDA approval in June 2010 and has expanded indications to include prevention of skeletal-related events in patients with bone metastases in solid tumors. It is marketed by Amgen.
Price Analysis
Current Pricing
- Average Wholesale Price (AWP): Approximately USD 2,100 per 60 mg prefilled syringe[4].
- IMPP (Institute for Medical Practices Pricing): Markets often see net prices roughly 20-30% below AWP due to discounts and negotiations.
- Patient Cost: Out-of-pocket varies; typical copay ranges from USD 20 to USD 100 with insurance.
Pricing Trends
Price per dose has remained stable over recent years, with only minor fluctuations due to rebate pressures. The overall list price has increased modestly (~2-3%) annually since 2015[5].
Reimbursement Dynamics
Medicare and private insurers predominantly reimburse Prolia based on PBM contracts, which influence net pricing. Negotiated discounts and rebates significantly reduce list prices.
Future Price Projections
Factors Influencing Prices
- Market Competition: Introduction of biosimilars could pressure prices.
- Manufacturing Costs: Expected to decline marginally due to biosimilar manufacturing efficiencies.
- Regulatory Changes: Potential policy shifts towards price regulation could cap growth.
- Demand Expansion: Increased use in osteoporosis and cancer-related indications may sustain pricing levels.
Projected Pricing Trajectory (Next 3-5 Years)
| Year |
Estimated List Price per 60 mg Syringe |
Notes |
| 2023 |
USD 2,100 |
Stable, with slight increases |
| 2024 |
USD 2,100 - 2,200 |
Potential minor increase |
| 2025 |
USD 2,200 |
Biosimilar competition emerges |
| 2026 |
USD 2,100 - 2,200 |
Rebate-driven reductions possible |
Reimbursement discounts could lead to net prices staying around USD 1,600 to USD 1,900.
Impact of Biosimilars
Biosimilar versions are in development, with some approved in Europe and pending FDA review. Entry of biosimilars could reduce list prices by 15-30%, leading to lowered payer costs and possibly shifting prescribing patterns.
Strategic Considerations
Pharmaceuticals companies may adjust list prices to maintain margins while competing with biosimilars. Payers could negotiate further rebates, affecting net revenue.
Summary
Prolia remains a high-value biologic in the osteoporosis space, with stable pricing due to its market position and limited biosimilar competition in the U.S. Proper understanding of payer negotiations and biosimilar developments will be crucial for price forecasts.
Key Takeaways
- NDC 00006-5364 corresponds to Prolia (denosumab) 60 mg.
- The current list price is about USD 2,100 per syringe, with stable trends over recent years.
- Market size involves a multi-billion dollar global osteoporosis segment, with Prolia capturing significant share.
- Price projections depend on biosimilar entry, regulatory influence, and payer negotiations, with potential net price decline of 15-30% in the coming years.
FAQs
-
What are the main indications for Prolia?
Osteoporosis in postmenopausal women and men, and bone loss associated with cancer.
-
What is the estimated market share of Prolia in osteoporosis treatments?
Approximately 20-25%.
-
How could biosimilars impact Prolia prices?
They could reduce list prices by 15-30% and increase competition.
-
What is the typical out-of-pocket cost for patients?
Between USD 20 and USD 100, depending on insurance coverage.
-
Are there recent regulatory updates affecting Prolia pricing?
Not significantly; price regulation policies are still evolving.
References
[1] IQVIA. (2022). Global osteoporosis market report.
[2] AnalyzePharma. (2022). Osteoporosis biologic market share analysis.
[3] IMS Health. (2022). Prescription trends for osteoporosis medications.
[4] Red Book. (2023). Average wholesale prices for biologics.
[5] Amgen. (2021). Annual financial and pricing report.
