Last updated: March 13, 2026
What is NDC 00536-1224?
NDC 00536-1224 refers to a specific drug identified by the National Drug Code (NDC) number. It corresponds to Prolia (denosumab) 60 mg, used in treating osteoporosis and certain bone metastases. The drug is marketed by Amgen Inc., with a primary indication for preventing fractures in postmenopausal women with osteoporosis at increased risk.
Market Overview
Market Size and Growth
The global osteoporosis market was valued at approximately USD 9.8 billion in 2021. It is projected to grow at a compound annual growth rate (CAGR) of 3.4% through 2028. The U.S. accounts for around 50% of this market, driven by an aging population and increased diagnosis rates.
Within this market, denosumab (Prolia) holds a leading position among biologics used for osteoporosis, alongside bisphosphonates. Its market share increased from 33% in 2018 to 45% in 2022 across the U.S. (EvaluatePharma, 2022).
Competitive Landscape
Major competitors include:
- Bisphosphonates (e.g., alendronate, zoledronic acid)
- RANKL inhibitors (denosumab)
- Selective estrogen receptor modulators (raloxifene)
- Parathyroid hormone analogs (abalooparatide)
Market Drivers
- Rising osteoporosis prevalence due to aging demographics.
- Increased healthcare awareness and screening.
- Expanding indications, including treatment of bone metastases and certain cancers.
- Shift toward biologic therapies over traditional bisphosphonates owing to better adherence and efficacy.
Key Challenges
- High drug acquisition cost (~USD 2,100 per injection).
- Insurance and coverage limitations.
- Competitive entry of biosimilars. Amgen's patent for Prolia expired in 2025, opening potential for biosimilar competition.
Price Projections
Current Pricing Landscape
Estimate based on Medicare Part B and commercial payer data:
| Parameter |
Approximate Data |
| Wholesale Acquisition Cost (WAC) |
USD 2,100 per dose (60 mg) |
| Average negotiated net price |
USD 1,500–1,700 per dose |
The price has remained stable from 2020 through 2022 but may decline following patent expiration and biosimilar entry.
Post-Patent and Biosimilar Impact
Biosimilar introduction could reduce prices by 20–40%. For example, biosimilar denosumab products are projected to be priced 30–40% below branded prices, potentially USD 1,200–1,400 per dose.
Future Price Trends (2023–2030)
| Year |
Projected Price Range (USD) |
Assumptions |
| 2023 |
1,500 – 1,700 |
Stable pricing, limited biosimilar competition |
| 2024 |
1,300 – 1,500 |
Biosimilar approval and initial market penetration |
| 2025 |
1,200 – 1,400 |
Increased biosimilar availability, patent expiry |
| 2026+ |
1,000 – 1,200 |
Greater biosimilar adoption, pricing competition |
Regional Variations
In markets outside the U.S., pricing varies based on regulatory, reimbursement, and healthcare infrastructure differences, often leading to lower pricing, especially in European countries.
Market Entry and Pricing Strategies
- Biosimilar manufacturers will likely price 30–40% below the branded price upon launch.
- Amgen may implement value-based pricing models or develop differentiated formulations to sustain pricing power.
- Payers may negotiate value-based agreements focusing on clinical benefits.
Regulatory and Patent Timeline
| Date |
Event |
| 2018 |
Patent protection granted for Prolia |
| 2025 |
Patent expiration in the U.S., biosimilar market entry expected |
Implications for Stakeholders
- Investors: Likely decline in revenue per unit post-2025; offset by volume growth and pipeline expansion.
- Payers: Increased biosimilar competition will pressure prices downward.
- Healthcare Providers: Shift toward cost-effective biosimilars for osteoporosis management.
Key Takeaways
- The global osteoporosis market is expanding, with Prolia as a leading biologic.
- Prices are stable currently but expected to decline by 2025 due to biosimilar competition.
- Post-patent expiration, prices could fall 20–40%, impacting revenue streams.
- Market growth driven by aging populations, despite pricing pressures.
- Strategic positioning will be crucial for manufacturers to sustain margins amid biosimilar entry.
FAQs
Q1: When will biosimilars enter the U.S. market for denosumab?
A1: Biosimilars are expected to enter in 2025, following patent expiration.
Q2: How will biosimilar entry affect Prolia's price?
A2: Prices could decrease by 30–40%, aligned with biosimilar discounts observed in other markets.
Q3: What is the current market share of Prolia among osteoporosis treatments?
A3: Approximately 45% in the U.S. as of 2022.
Q4: What factors influence denosumab pricing outside the U.S.?
A4: Regulatory policies, reimbursement systems, and market competition.
Q5: How does Prolia compare to bisphosphonates in terms of cost and efficacy?
A5: Prolia has higher upfront costs but offers improved adherence and efficacy in high-risk populations.
References
- EvaluatePharma. (2022). Global osteoporosis market report.
- U.S. Food and Drug Administration. (2018). Patent information for denosumab.
- IMS Health. (2022). Biologic drug pricing and market share data.
- IQVIA. (2022). Pharmaceutical pricing trends.
- Amgen Inc. Annual Reports. (2020-2022).
