Last updated: March 22, 2026
What is the drug with NDC: 76282-0545?
This National Drug Code (NDC) corresponds to Ravulizumab-cwvz (Ultomiris), a monoclonal antibody developed by Alexion Pharmaceuticals. It is approved for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and other complement-mediated diseases.
Market landscape for Ravulizumab (Ultomiris)
Market size and growth
- Global Market Value (2022): Estimated at approximately $2.2 billion, with a Compound Annual Growth Rate (CAGR) of 11% projected through 2027.[1]
- U.S. Market Share: Accounts for nearly 55% of total sales, driven by higher disease prevalence and reimbursement factors.
- Key competitors:
- Eculizumab (Soliris, Alexion)
- C1 esterase inhibitor (Cinryze, Shire)
- Other emerging complement inhibitors
Key indications
- Paroxysmal nocturnal hemoglobinuria (PNH)
- Atypical hemolytic uremic syndrome (aHUS)
- Generalized Myasthenia Gravis (MG)
- Other complement-driven disorders
Market penetration
- First approved: 2018 (FDA)
- Market adoption: Rapid, due to longer dosing intervals than eculizumab
- Pricing benefit: Dosing reductions improve patient compliance and decrease administration costs
Pricing analysis
Current pricing structure (U.S. retail prices)
- Per treatment dose: Approximately $464,000 for an initial infusion (based on average weight 80kg, dosing schedule 4-8 weeks)
- Annual cost: Estimated at $465,000 to $465,000 per patient
Price comparison with eculizumab (Soliris)
| Parameter |
Ravulizumab (Ultomiris) |
Eculizumab (Soliris) |
| Dosing interval |
8 weeks |
2 weeks |
| Cost per dose |
~$464,000 |
~$675,000 |
| Annual cost |
~$464,000 |
~$675,000 |
Ravulizumab’s price reduction stems from its extended dosing interval, offering a 30-35% cost savings versus eculizumab on a per-year basis.
Market entry and reimbursement considerations
- Reimbursement: Coverage through Medicare, Medicaid, private payers
- Pricing pressures: Increasing for biologics; payers are seeking discounts and patient assistance programs
- Regulatory status: Approved in multiple geographies, with ongoing expansion into EU, Japan, and other markets
Regulatory and patent landscape
- Patent protection: Expiry in key markets scheduled for 2030-2035, with pipeline continuity plans
- Orphan drug designation: granted for specific indications, providing market exclusivity extensions
Future price trends and sales projections
Assumptions:
- Compound annual growth rate: 11%
- Market expansion: Incremental approval for additional indications (e.g., MG, cold agglutinin disease)
- Competitive pressure: Moderate, with patent exclusivity protecting pricing
Price trajectory
| Year |
Estimated average price per patient |
Market size (patients) |
Total sales (USD) |
| 2023 |
$465,000 |
4,500 |
$2.09 billion |
| 2025 |
$517,000 |
6,000 |
$3.1 billion |
| 2027 |
$576,000 |
8,000 |
$4.6 billion |
These projections assume steady market penetration, no significant price reductions, and expansion into new territories and indications.
Key factors impacting the market and pricing
- Emerging therapies: New complement inhibitors could challenge dominant players.
- Pricing negotiations: Payers’ reimbursement policies and formulary placements will influence net prices.
- Biologic biosimilars: Not yet available, but potential future impact if approved.
- Regulatory approvals: Additional indications and geographic expansion could boost sales.
Key Takeaways
- Market size: Ravulizumab is a multibillion-dollar biologic, largely driven by its use in PNH and aHUS.
- Pricing: Current list price for treatment approximates $464,000 per year with significant savings over eculizumab.
- Growth prospects: Driven by additional indications and geographic expansion, with sales projected to reach nearly $4.6 billion by 2027.
- Competitive and regulatory risks: Patent expirations and emerging biosimilar competition could influence future prices.
- Market dynamics: Payer negotiations and the emergence of alternative therapies will shape the future pricing landscape.
FAQs
Q1: How does Ravulizumab compare to Eculizumab in terms of efficacy?
It is non-inferior in clinical trials for PNH and aHUS, with comparable safety profiles. Its main advantage is less frequent dosing.
Q2: Are there upcoming patent expirations for Ravulizumab?
Yes, patent protections in major markets are expected to expire between 2030 and 2035; biosimilar competition could follow.
Q3: What factors could alter the forecasted sales?
Introduction of biosimilars, new indications, pricing negotiations, or regulatory barriers pose risks.
Q4: How will the market for complement inhibitors evolve?
New drugs with different mechanisms or improved profiles could compete, potentially reducing prices.
Q5: What pricing strategies do manufacturers use for biologics like Ravulizumab?
Strategies include offering discounts, patient assistance programs, and negotiating value-based pricing with payers.
References
[1] MarketWatch. (2022). Global complement inhibitor market size. Retrieved from https://www.marketwatch.com/
