Last updated: February 21, 2026
What is the Status of NDC 35573-0447?
NDC 35573-0447 corresponds to Ravulizumab-cwvz (Ultomiris), developed by Alexion Pharmaceuticals (a subsidiary of AstraZeneca). It is indicated for complement-mediated diseases such as paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Approved by the FDA in December 2018, it is a long-acting C5 complement inhibitor.
Market Size and Demand Drivers
Indications and Patient Population
| Condition |
Estimated US Patients (2023) |
Global Patient Estimate |
Key Factors |
| PNH |
1,500–2,000 |
4,000–5,000 |
Increasing diagnosis rates, longer survival |
| aHUS |
1,000–1,500 |
3,000–4,000 |
Improved awareness, genetic testing |
| Other complement-mediated diseases |
1,000 |
2,000 |
Rare disease niche, expanding indications |
Market Penetration
As of late 2023, Ultomiris holds approximately 60–70% of the market share for complement inhibitors in rare diseases, competing primarily with Soliris (eculizumab by Alexion/AstraZeneca) and emerging biosimilars.
Competitor Landscape
| Drug |
Manufacturer |
Indications |
Approval Date |
Market Share (2023) |
Annual Revenue (2022) |
| Eculizumab (Soliris) |
Alexion |
PNH, aHUS, others |
2007 |
50–60% |
$4.8B |
| Ravulizumab (Ultomiris) |
Alexion |
PNH, aHUS |
2018 |
40–45% |
$2.4B |
Sales Trends
Sales of Ultomiris increased 35% from 2021 to 2022, reflecting expanding approval for additional indications and increased market penetration. Growth is expected to plateau as the patient population reaches near-saturation.
Price Structure and Revenue Projections
Current Pricing
| Country |
Estimated Wholesale Price (Per Dose) |
Dosage Frequency |
Annual Cost per Patient (USD) |
| US |
$509,000 (approximate) |
Every 8 weeks |
$510,000–$550,000 |
| EU |
€400,000 |
Monthly |
€440,000–€480,000 |
In the US, the average annual treatment cost ranges from $510,000 to $550,000, influenced by dosing adjustments and patient weight.
Revenue Projections (2023–2027)
Assumptions:
- Market Penetration Growth: 5% annually until 2025, plateau thereafter.
- Patient Population Growth: 2% annually.
- Average Annual Price per Patient: $530,000.
| Year |
Estimated Patients |
Total Revenue (USD) |
Key Drivers |
| 2023 |
2,000 |
$1.06B |
Current market size, price stability |
| 2024 |
2,200 |
$1.17B |
Patient growth, market share increase |
| 2025 |
2,420 |
$1.28B |
Tight market, approaching saturation |
| 2026 |
2,470 |
$1.30B |
Stable, minimal growth |
| 2027 |
2,520 |
$1.33B |
Market plateau |
Demand for even newer or biosimilar therapies could limit upside beyond 2025. Price adjustments may occur due to payer negotiations and biosimilar competition.
Key Market Dynamics and Risks
- Biosimilar Competition: Entry of biosimilars similar to eculizumab could pressure prices and market share.
- Regulatory approvals: Expansion into new indications or geographies could increase revenue.
- Pricing pressures: Payer negotiations, especially in managed care and government programs, could reduce effective price per dose.
- Manufacturing disruptions or supply chain issues could impact availability and sales.
Conclusion
Ravulizumab-cwvz holds a significant share in the niche market for complement-mediated diseases, with revenues projected to reach approximately $1.3 billion in North America by 2027. Growth will depend on market expansion, biosimilar entry, and regulatory developments.
Key Takeaways
- The primary market is the US, with experimental expansion into other regions.
- Current annual revenue per patient approaches $530,000.
- The market saw a 35% increase in revenue from 2021 to 2022.
- Competition from biosimilars and generics remains a key risk.
- Revenue growth will slow as the patient population saturates, stabilizing around $1.3 billion annually by 2027.
FAQs
Q1: What is the current market size for Ravulizumab?
A1: Estimated at approximately 2,000 patients in the US, with total revenue around $1.06 billion in 2023.
Q2: How does the price of Ultomiris compare to Soliris?
A2: Ultomiris costs roughly 10–20% less per dose than Soliris, due to longer dosing intervals and negotiated discounts.
Q3: What are the key risks to revenue growth?
A3: Biosimilar competition, market saturation, and payer price negotiations.
Q4: Are there plans for expanding indications?
A4: Regulatory efforts are ongoing for additional rare disease indications, which could expand the market.
Q5: How are international markets expected to perform?
A5: Limited by regulatory approvals and healthcare infrastructure; growth is projected to be slower than in the US.
References
- FDA. (2018). Ultomiris approval notice. https://www.fda.gov
- Alexion Pharmaceuticals. (2022). Annual Report. https://alexion.com
- EvaluatePharma. (2022). World Preview 2022.
- IQVIA. (2023). Pharmaceutical Market Data.
- MarketLine. (2023). Rare Disease Market Analysis.
