Last updated: February 25, 2026
What is NDC 83324-0028?
NDC 83324-0028 is a drug listed under the National Drug Code system. Based on available data, it corresponds to Prolia (denosumab), indicated primarily for osteoporosis treatment in postmenopausal women, adult men at high risk of fracture, and certain cancer-related bone conditions.
Market Landscape
Market Size
- Global osteoporosis drug market was valued at approximately USD 9 billion in 2022 and is expected to grow at a CAGR of 3.5% through 2028 (Source: Grand View Research).
- Denosumab segment accounts for over USD 3 billion globally in 2022 (Source: IQVIA).
Key Competitors
| Drug |
Class |
Estimated 2022 Revenue |
Market Share (2022) |
| Prolia (denosumab) |
Monoclonal antibody |
USD 2.8 billion |
30-35% |
| Forteo (teriparatide) |
Recombinant PTH |
USD 1.2 billion |
10-15% |
| Evenity (romosozumab) |
Monoclonal antibody |
USD 600 million |
5-7% |
| Others |
Various |
USD 4.4 billion |
45-50% |
Regulatory and Market Entry Barriers
- Patent protections for denosumab products extend until approximately 2030, with some patents expiring earlier due to litigation.
- Market entry requires significant clinical evidence, especially for biosimilars.
Company Dynamics
- Amgen is the primary manufacturer for denosumab products.
- Biosimilar development is active in regions like the EU and Asia, aiming for approval by 2025-2027.
Price Trends and Projections
Current Pricing
| Region |
Average Wholesale Price (AWP) per 60 mg dose |
Notes |
| US |
USD 1,250 |
Pricing varies by supplier and patient insurance. |
| EU |
Approx. EUR 850 (~USD 900) |
Lower prices due to regional negotiations. |
Factors Affecting Pricing
- Patent expiration drives biosimilar competition, expected around 2028-2030.
- Healthcare policies in the US favor value-based pricing with increasing insurance coverage.
- Generic biosimilar entries typically reduce prices by 20-30% within 2-3 years post-approval.
Projected Price Trends (2023–2030)
| Year |
US Average Wholesale Price (USD) |
EU Estimated Price (EUR) |
| 2023 |
USD 1,250 |
EUR 850 (~USD 900) |
| 2025 |
USD 1,200 |
EUR 800 (~USD 850) |
| 2027 |
USD 1,150 |
EUR 750 (~USD 800) |
| 2030 |
USD 1,100 |
EUR 700 (~USD 750) |
Prices are projected to decline gradually, primarily due to biosimilar competition and increased market penetration.
Revenue Forecasts
- 2023–2025: USD 2.8–3.2 billion annually, assuming steady demand.
- 2026–2030: Potential growth to USD 3.5 billion by 2030, contingent on biosimilar market entry and pricing pressures.
Key Risks
- Patent litigation extending exclusivity.
- Regulatory delays for biosimilars.
- Changes in healthcare reimbursement policies affecting demand and pricing.
Summary
NDC 83324-0028 (Prolia) remains a leading drug in osteoporosis treatment, with market share sustained by high efficacy and brand loyalty. The market will face increased competition from biosimilars starting around 2028. Price reductions are expected in line with biosimilar approvals, with downward pressure of approximately 20-30% within three years of biosimilar entry.
Key Takeaways
- The global osteoporosis drug market is expanding, with denosumab representing over USD 3 billion annually.
- Current prices in the US average USD 1,250 per dose, trending downward.
- Biosimilar competition from 2028 onwards could reduce prices by up to 30%.
- Revenue projections indicate steady growth until patent cliffs and biosimilar entry.
- Regulatory, legal, and policy developments significantly influence market trajectory.
FAQs
1. When will biosimilars for denosumab likely enter the market?
Biosimilars are expected to file for approval starting around 2025, with commercial availability projected for 2027-2028.
2. How will patent expirations impact pricing?
Patent expirations open the market for biosimilars, leading to price reductions of 20-30% over 2-3 years.
3. What regions will see the highest price declines?
European markets typically experience more aggressive price reductions due to regional healthcare negotiations, compared to the US.
4. Are there new competitors in development?
Yes, biosimilar versions of denosumab are under clinical development by several Asian and European companies.
5. How do regulatory policies influence market entry?
Stringent approval processes and patent litigations can delay biosimilar entry, affecting price and market share dynamics.
References
[1] Grand View Research. (2022). Osteoporosis Drugs Market Size, Share & Trends Analysis Report.
[2] IQVIA. (2022). Global Oncology and Hematology Market Data.
[3] U.S. Food & Drug Administration. (2022). Biosimilar Product Development and Approval.
[4] European Medicines Agency. (2023). Biosimilar Medicines.
