Last updated: March 22, 2026
What is NDC 00955-1008?
NDC 00955-1008 is the National Drug Code identifier for Prolia (denosumab), marketed by Amgen. It is a monoclonal antibody used to treat osteoporosis, metastatic bone disease, and certain cancers. Approved by the FDA in 2010, it is administered via subcutaneous injection.
Market Size and Trends
Current Market Dynamics
- Global Osteoporosis Treatment Market (2022): Estimated at USD 9.2 billion; projected CAGR of 4.2% through 2030 (Grand View Research).
- U.S. Market Share: Approximate 70% of the global market; driven by aging demographics and osteoporosis prevalence.
Key Competitors
| Drug |
Manufacturer |
Approval Year |
Indications |
Mode of Action |
| Denosumab |
Amgen |
2010 |
Osteoporosis, bone metastases |
RANKL inhibitor |
| Alendronate |
Pfizer |
1995 |
Osteoporosis |
Bisphosphonate |
| Raloxifene |
Evista (Eli Lilly) |
1997 |
Postmenopausal osteoporosis |
Selective Estrogen Receptor Modulator (SERM) |
Denosumab dominates the anti-resorptive segment, with sales exceeding USD 3 billion in 2022.
Market Drivers
- Increasing elderly population worldwide.
- Rising osteoporosis diagnoses.
- Expanding indications for metastatic and cancer-related bone disease.
Pricing and Reimbursement
- Average Wholesale Price (AWP): Approximately USD 2,100 per injection (based on regional pricing).
- Reimbursement Coverage: Varies; Medicare in the U.S. covers denosumab for osteoporosis.
Price Projection Analysis (2023–2027)
Prices are subject to fluctuations based on competition, patent statuses, and healthcare policies. The following projections assume current pricing structures hold, with inflation and patent expirations influencing long-term trends.
| Year |
Estimated Price per Dose |
Key Factors |
| 2023 |
USD 2,100 |
Stable, with reimbursement adjustments. |
| 2024 |
USD 2,100 – 2,200 |
Possible minor increases due to inflation. |
| 2025 |
USD 2,200 – 2,300 |
Patent exclusivity reduces, potential launch of biosimilars. |
| 2026 |
USD 2,400 – 2,600 |
Entry of biosimilars in key markets; increased competition. |
| 2027 |
USD 2,500 – 2,700 |
Biosimilar proliferation may pressure prices downward. |
Biosimilar entries expected post-2025 in the U.S. and Europe could reduce prices by 20-40% over two years.
Patent and Regulatory Landscape
- Patent for Prolia protection is set to expire around 2025 in major markets.
- Biosimilars are under development in Europe and the U.S., with at least three candidates in Phase 3 trials as of 2022.
- Regulatory pathways for biosimilar approval aim to reduce barriers, fostering competition.
Market Risks
- Patent challenges could result in earlier biosimilar entry.
- Policy shifts in healthcare reimbursement could impact pricing.
- New treatments, such as oral osteoporosis agents, could erode market share.
Conclusions
Prolia remains a high-value drug with a stable pricing outlook constrained by imminent biosimilar competition. Price reductions are anticipated starting in 2025, driven by patent expirations and biosimilar market entry. The U.S. and Europe represent the primary markets; Asia-Pacific may see growth but with price sensitivity.
Key Takeaways
- NDC 00955-1008 (Prolia) is a dominant osteoporosis treatment, with sales exceeding USD 3 billion globally.
- Market growth driven by aging demographics and expanding indications.
- Pricing remains stable for the immediate future but faces significant decline from 2025 onward due to biosimilar competition.
- Patent expirations around 2025 open the market to biosimilars, which could reduce prices by up to 40%.
- Market risks include policy changes, biosimilar approval timelines, and new therapies emerging.
FAQs
1. When does patent expiration for Prolia occur?
Patent protection is expected to expire around 2025 in major markets, opening the pathway for biosimilar entrants.
2. How many biosimilars are in development for denosumab?
At least three biosimilar candidates are in Phase 3 trials as of 2022, with approvals anticipated post-2025.
3. What is the typical price of Prolia in the U.S.?
Approximately USD 2,100 per dose, with variations based on insurance and pharmacy discounts.
4. Will biosimilars have an immediate impact on pricing?
Biosimilar entries generally lead to price reductions within two years, typically between 20-40%.
5. What are the main factors influencing the market growth of denosumab?
Aging population, rising osteoporosis diagnoses, increasing use in cancer-related bone diseases, and expanding indications.
References
- Grand View Research. (2022). Osteoporosis Treatment Market Size, Share & Trends Analysis Report.
- U.S. Food and Drug Administration. (2010). Prolia (denosumab) approval details.
- IQVIA. (2022). Healthcare Data Report: US Prescription Market.
- Biosimilar Development Pipeline. (2022). European Medicines Agency.
- Centers for Medicare & Medicaid Services. (2022). Reimbursement Policies for Osteoporosis Drugs.
