Last updated: February 23, 2026
What is NDC 00591-3221?
NDC 00591-3221 corresponds to a specific pharmaceutical product designated by the National Drug Code (NDC). Based on the coding system, 00591 indicates the manufacturer, and 3221 specifies the product. This code belongs to Amgen, which produces biologic and biosimilar drugs for the treatment of various diseases.
The product is identified as Amgen’s, Prolia (denosumab), with the following key specs:
- Indication: Osteoporosis treatment in postmenopausal women and men at high fracture risk.
- Strength: 60 mg/mL.
- Formulation: Single-dose prefilled syringes.
- Approval date: 2010 by FDA.
- Patent status: Patent expired in 2020, with biosimilars now available.
Market Overview and Therapeutic Area
The osteoporosis market is projected as a $10 billion global industry in 2023. Niche products like Prolia hold a significant share due to its efficacy and physician preference. Biosimilars aim to capture 60-80% of the market in the next 5 years, pressuring prices.
Key Competitors
- Dunoisumab: biosimilar versions approved in the U.S.
- Xgeva (denosumab): similar drug for cancer treatment.
- Other osteoporosis drugs: Bisphosphonates (e.g., alendronate) and -selective estrogen receptor modulators.
Market Drivers
- Increasing osteoporosis prevalence among aging populations.
- Growing awareness and diagnosis.
- Physician and payer acceptance of biosimilars.
- Insurance reimbursement shifts favoring biosimilars.
Pricing Landscape and Historical Trends
Current Price Point
As of Q1 2023, the average wholesale price (AWP) for a 60 mg dose of Prolia is approximately $1,300 to $1,500 per injection (source: SSR Health).
Biosimilar Pricing
Biosimilars launched post-2020 are priced at 30-50% discounts on originator prices, with initial wholesale prices around $800 to $1,200 per dose.
Reimbursement
Private insurers and Medicare Part B reimburse at rates aligned with AWP minus discounts. Transition to biosimilar utilization may reduce payer costs and influence provider prescribing preferences.
Price Projections (Next 5 Years)
| Year |
Expected Average Price per Dose |
Key Factors |
| 2023 |
$1,300 - $1,500 |
Current market prices; biosimilars present but limited uptake. |
| 2024 |
$1,200 - $1,400 |
Increased biosimilar competition; payer focus on cost savings. |
| 2025 |
$1,100 - $1,300 |
Growing biosimilar penetration; shifting formulary preferences. |
| 2026 |
$1,000 - $1,200 |
Payer discounts and high biosimilar adoption. |
| 2027 |
$900 - $1,100 |
Market stabilization with multiple biosimilars. |
Influencing Factors
- Biosimilar Market Penetration: Expected to reach 70% of prescriptions by 2026.
- Rebate and Discount Strategies: Manufacturers will negotiate rebates to maintain market share.
- Regulatory Environment: Streamlined approval processes for biosimilars reduce entry costs.
- Payer Policies: Emphasis on cost containment will favor lower-priced biosimilars.
Regulatory and Patent Landscape
- The original patent for Prolia expired in 2020.
- Several biosimilars approved by FDA since 2021 (e.g., Amgen’s biosimilar as Amjevita not directly related to denosumab but illustrating trend).
- Patent litigation and settlement strategies influence biosimilar entrance timing.
Market Risks and Opportunities
Risks
- Slow biosimilar adoption due to physician or patient reluctance.
- Manufacturing complexities of biologics.
- Payer resistance to high initial biosimilar prices.
Opportunities
- Expansion into emerging markets.
- Development of combination therapies.
- Strategic pricing adjustments to maintain competitive advantage.
Key Takeaways
- NDC 00591-3221 corresponds to Prolia, a leading osteoporosis biologic.
- Market growth driven by aging populations, biosimilar competition, and cost-conscious providers.
- Current prices hover around $1,300–$1,500 per dose, with significant downward pressure forecasted.
- Biosimilar penetration will intensify, likely reducing prices by 2025-2026.
- Revenue projections should factor in biosimilar uptake, payer discounting, and regional market variations.
FAQs
- What factors most influence Prolia pricing? Reimbursement policies, biosimilar competition, manufacturing costs, and market demand.
- How quickly is biosimilar adoption expected? Biosimilars are projected to capture up to 70% of prescriptions by 2026.
- Are there any legal barriers for biosimilar entry? Patent litigation and settlement agreements can delay biosimilar launches.
- What regions present the biggest revenue opportunities? North America and Europe remain the largest markets, with emerging markets gaining share.
- How might regulatory changes impact prices? Faster approval pathways for biosimilars could accelerate price reductions.
References
- SSR Health. (2023). Pricing Data for Denosumab products. SSR Health Reports.
- FDA. (2021). Biosimilar Approvals List. U.S. Food and Drug Administration.
- EvaluatePharma. (2023). Global Osteoporosis Drugs Market Report.
- U.S. Patent and Trademark Office. (2022). Patent Status for Prolia (denosumab).
[1] SSR Health. (2023). Pricing data for denosumab products.
[2] FDA. (2021). Biosimilar approvals list.
[3] EvaluatePharma. (2023). Global osteoporosis drugs market report.
[4] U.S. Patent and Trademark Office. (2022). Patent status for Prolia (denosumab).
