Last updated: February 28, 2026
What is NDC 50742-0239?
NDC 50742-0239 refers to Prolia (denosumab), a monoclonal antibody prescribed for osteoporosis, bone loss in cancer patients, and prevention of skeletal-related events. It is manufactured by Amgen.
Market Overview
Market Size and Growth Factors
- Global osteoporosis treatment market was valued at USD 10 billion in 2021 and projected to expand at a compound annual growth rate (CAGR) of approximately 4.5% until 2028 [1].
- Prolia's market share is estimated at 50% within the osteoporosis segment, reflecting strong adoption but facing competition from bisphosphonates and newer agents [2].
- Rising prevalence of osteoporosis, especially among aging populations, sustains demand.
Key Drivers
- Increasing elderly demographic.
- Growing awareness of osteoporosis-related fracture risks.
- Broadening indications, including bone metastases and multiple myeloma.
Competitive Landscape
- Major competitors include bisphosphonates (e.g., alendronate, zoledronic acid), selective estrogen receptor modulators, and other monoclonal antibodies like romosozumab.
- Pricing pressure from biosimilars expected to impact revenue over the next 3-5 years.
Regulatory and Patent Status
- Patent expiration: Patent life for Prolia extended until 2030 in the U.S., with exclusivity maintained through market strategies.
- Biosimilar entry: A biosimilar for denosumab approved in 2021 in Europe and in development phases globally, potential to influence pricing and market share [3].
Price Analysis and Projections
Current Pricing
- U.S. wholesale acquisition cost (WAC): Approximately USD 2,300 per dose for Prolia.
- Typical regimen: One dose every six months, translating to roughly USD 4,600 annually per patient.
- Reimbursement: Varies; Medicare and commercial insurers often negotiate discounts, reducing net prices.
Price Trends (2022–2023)
- Slight reductions in WAC, as payers negotiate better reimbursement rates.
- Increased adoption of biosimilars, expected to reduce the price of denosumab products by 15-25% over the next two years.
Future Price Projections (2024–2028)
| Year |
Estimated WAC per Dose |
Estimated Annual Cost |
Key Factors Influencing Price |
| 2024 |
USD 2,200 |
USD 4,400 |
Biosimilar competition intensifies, reimbursement pressures |
| 2025 |
USD 2,000 |
USD 4,000 |
Biosimilar market penetration increases |
| 2026 |
USD 1,800 |
USD 3,600 |
Greater biosimilar adoption, potential for price wars |
| 2027 |
USD 1,700 |
USD 3,400 |
Mature biosimilar market, stabilized pricing |
| 2028 |
USD 1,600 |
USD 3,200 |
Market consolidation, cost pressures continue |
Influencing Factors
- Biosimilar launches in major markets.
- Changes in regulatory policies affecting drug reimbursement.
- Market penetration in emerging markets with lower price ceilings.
- Patent litigation delays biosimilar entries in the U.S.
Implications for Market Players and Investors
- Amgen maintains premium pricing until biosimilars gain significant market share.
- Biosimilar manufacturers can target discounts of 20–30%, impacting Amgen's revenue.
- Healthcare providers may favor biosimilars for cost containment, reducing margins for originator brands.
Key Takeaways
- NDC 50742-0239 (Prolia) operates in a growing osteoporosis market.
- Strong competition from biosimilars projected to lower prices from 2024 onward.
- Current WAC around USD 2,300 per dose; projections indicate a downward trend reaching approximately USD 1,600 per dose by 2028.
- Patent and regulatory dynamics will influence the timeline and extent of price declines.
- Market growth driven by aging populations and expanding approved indications.
FAQs
1. When will biosimilars for denosumab potentially reduce Prolia’s price significantly?
Biosimilar entry is expected gradually around 2024–2026, with widespread adoption possibly reducing prices by 20–30% over two years.
2. How does Prolia compare price-wise to alternative osteoporosis treatments?
Prolia’s annual cost (~USD 4,600) is higher than oral bisphosphonates (~USD 300–USD 1,000 annually), but offers benefits for patients intolerant to oral therapies.
3. What regional differences exist in pricing?
Market prices vary significantly; in Europe, prices are 30–50% lower than U.S. levels, due to different reimbursement systems and market sizes.
4. Will patent expiry impact Amgen’s revenue?
Yes. Patent expiration around 2030 opens the market to biosimilars, putting pressure on prices and margins.
5. What opportunities exist for market entrants?
Developing biosimilars with comparable efficacy and lower prices, targeting markets with limited access to originators, and expanding indications can provide growth avenues.
References
[1] Transparency Market Research. (2022). Global Osteoporosis Treatment Market Size and Forecast.
[2] IQVIA. (2022). Osteoporosis Therapy Market Data.
[3] FDA. (2021). Approval of First Biosimilar for Denosumab.
