Last updated: February 20, 2026
What is NDC 00228-3059?
NDC 00228-3059 corresponds to Ravulizumab (Ultomiris), a complement inhibitor used to treat paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Developed by Alexion Pharmaceuticals, now a part of AstraZeneca, Ravulizumab is a long-acting monoclonal antibody replacing eculizumab (Soliris).
Market Landscape
Market Size and Growth Drivers
- Indications: PNH, aHUS, and other complement-mediated diseases.
- Current Sales: Estimated global sales of Ravulizumab reached approximately $1.2 billion in 2022.
- Growth Rate: Compound annual growth rate (CAGR) estimated at 6% from 2023-2027.
- Key Competitors: Eculizumab (Soliris), developing biosimilars and next-generation complement inhibitors.
Regulatory Status and Approvals
- FDA: Approved in December 2018 for PNH and aHUS.
- EMA: Approved in February 2019.
- Pricing in U.S.: List price approximately $491,000 per year per patient (per American Journal of Managed Care, 2022).
Prescriber Adoption and Market Penetration
- Uptake remains steady but faces competition from newer therapies and biosimilars.
- Market penetration is highest in North America, followed by Europe and select Asia-Pacific markets.
Price Trends and Projections
Current Pricing Model
- Annual Cost per Patient: ~$491,000 in the US.
- Pricing Strategy: Fixed yearly price; discounts and rebates are common among payers.
Historical Pricing Trends
- Ravulizumab launched at similar pricing to eculizumab but with a dosing schedule extension (every 8 weeks vs. every 2 weeks).
- Since launch, price adjustments have been minimal, driven by inflation and healthcare inflation rates.
Future Price Projections (2023-2027)
| Year |
Estimated Price per Patient |
Notes |
| 2023 |
$491,000 |
Stable, with expected slight discounts for payers |
| 2024 |
$493,000 |
Slight increase expected due to inflation |
| 2025 |
$495,000 |
No major price reforms anticipated |
| 2026 |
$497,000 |
Competitive pressure may limit hikes |
| 2027 |
$500,000 |
Price stabilize or slight decline with biosimilar entry |
Assumptions:
- No significant regulatory changes lowering prices.
- Patent exclusivity until 2030 limits biosimilar competition in the US.
- Pricing strategies may shift toward value-based agreements, potentially reducing list prices in negotiated contracts.
Impact of Biosimilar Entry
- Biosimilar development is active; FDA has not yet approved biosimilars for Ravulizumab.
- Generic or biosimilar entry could reduce prices by 30-50% once approved and adopted.
- Biosimilar competition expected by 2028, potentially accelerating price declines.
Pricing Comparison
| Drug |
Pricing (USD/year) |
Indication |
Dosing Schedule |
| Ravulizumab (Ultomiris) |
~$491,000 |
PNH, aHUS |
Every 8 weeks |
| Eculizumab (Soliris) |
~$639,000 |
PNH, aHUS |
Every 2 weeks |
| Biosimilar candidates |
Potentially 30-50% lower |
Pretenders in pipeline |
Varies (biosimilar design) |
Market Risks and Uncertainties
- Entry of biosimilars, especially from major pharma players.
- Regulatory changes affecting pricing or reimbursement policies.
- Market penetration slowdowns due to insurance coverage limits.
- Patent expiration pressure after 2030.
Conclusions
- Ravulizumab maintains a premium pricing position with minimal variation expected until biosimilar competition.
- Price projections indicate stability until biosimilars enter the market, after which potential reductions of 30-50% could occur.
- The market's growth continues driven by expanding indications and increasing awareness, but pricing will become critical in maintaining revenue margins.
Key Takeaways
- Ravulizumab's US list price remains at roughly $491,000 annually, with minimal increases forecasted through 2027.
- Biosimilar entry anticipated by 2028 could substantially lower prices.
- The market continues to grow approximately 6% annually, with dominance in North America.
- Price negotiations and value-based contracts may influence actual reimbursement levels.
- Ongoing competition from newer complement inhibitors and biosimilars pose long-term risks.
FAQs
1. What factors influence Ravulizumab’s price stability?
Market exclusivity, patent protections until 2030, lack of immediate biosimilar competition, and the drug's life-saving efficacy sustain its high price.
2. How might biosimilars affect Ravulizumab’s market share?
Biosimilars could reduce prices by 30-50%, leading to increased market share for cheaper alternatives once approved and adopted by payers.
3. Are there new indications that could impact pricing?
Yes, expansion into other complement-mediated disorders could increase demand but may also prompt negotiations to limit price increases.
4. What is the expected impact of healthcare policy changes?
Policy shifts toward value-based pricing and tighter reimbursement controls could pressure list prices downward.
5. How competitive is the market for complement inhibitors?
Highly competitive, with multiple pipeline agents and biosimilars. Innovation and patent expirations are key dynamics to monitor.
References
- American Journal of Managed Care. (2022). Price analysis of Ravulizumab.
- AstraZeneca. (2023). Ultomiris product information.
- U.S. Food and Drug Administration. (2018). Final approval letter for Ravulizumab.
- European Medicines Agency. (2019). Ultomiris approval data.
- MarketWatch. (2023). Biologics market trends report.
