Last updated: February 25, 2026
What is NDC 59467-0679?
NDC 59467-0679 corresponds to a specific drug product listed in the National Drug Code (NDC) database. This code identifies a branded or generic pharmaceutical product. Based on the latest available data, NDC 59467-0679 refers to Ravulizumab (trade name Ultomiris), a monoclonal antibody used primarily for complement-mediated diseases.
Market Landscape
Indications and Off-Label Uses
Ravulizumab (Ultomiris) is approved for:
- Paroxysmal Nocturnal Hemoglobinuria (PNH)
- Atypical Hemolytic Uremic Syndrome (aHUS)
- Generalized Myasthenia Gravis (gMG)
Off-label, it has been investigated for other complement-related disorders. The drug's market is concentrated among rare disease treatment centers due to its high cost.
Competitive Environment
The primary competitor is Eculizumab (Soliris), which was the first complement inhibitor approved for PNH and aHUS.
| Drug |
Manufacturer |
Approved Indications |
Market Share (2022) |
| Ravulizumab (Ultomiris) |
Alexion (a Roche subsidiary) |
PNH, aHUS, gMG |
65% (estimated) |
| Eculizumab (Soliris) |
Alexion |
PNH, aHUS, other off-label uses |
35% (estimated) |
Market Size & Forecast
- The global market for complement inhibitors is projected to reach $2.5 billion by 2027.
- The PNH segment dominates, accounting for over 70% of the revenue.
- The rare disease drug market overall is growing annually at approximately 10%, driven by increased diagnosis rates and expanded indications.
Market Drivers
- High unmet medical needs for rare diseases.
- Improved understanding of complement biology.
- Expanding approval for off-label and new indications.
- Competitive pricing strategies by drug manufacturers.
Pricing Trends
Current Price Point
The list price for Ravulizumab (Ultomiris) is approximately $525,000 to $600,000 per year per patient.
Pricing Components
- The annual drug cost is influenced by dosing regimens: Ravulizumab is administered every 8 weeks after initial loading, reducing infusion frequency versus eculizumab, which is administered weekly.
- The average per-infusion cost is estimated at $10,000 to $12,000.
- The total annual cost incorporates monitoring, hospital overhead, and supportive care, raising the effective cost to roughly $550,000 annually.
Price Trends & Factors
- Price increases on existing drugs tend to be 3-5% annually.
- Biosimilar entry remains limited due to regulatory hurdles in rare diseases.
- Negotiated discounts through pharmacy benefit managers (PBMs) may lower net prices by 10-20%.
Price Projections (Next 5 Years)
| Year |
Estimated Price Range |
Notes |
| 2023 |
$550,000 - $600,000 |
Baseline; steady pricing with minor increases |
| 2024 |
$560,000 - $610,000 |
Inflation adjustments and demand growth |
| 2025 |
$565,000 - $615,000 |
Possible slight discounting pressure |
| 2026 |
$570,000 - $620,000 |
Potential for new indications |
| 2027 |
$575,000 - $625,000 |
Market maturity; pricing plateau |
Factors Influencing Future Pricing and Market Share
- The introduction of biosimilars or alternative therapies could pressure prices.
- Expanded indications, such as treatments for atypical hemolytic uremic syndrome variants, may increase demand.
- Reimbursement policies, including insurance negotiations, could impact net prices.
- Patent protections, data exclusivity periods, and regulatory approvals influence market control.
Summary
| Aspect |
Details |
| Leading Product |
Ravulizumab (Ultomiris) |
| Market Size (2023) |
Estimated at $1.8 billion globally |
| Price Range (2023) |
$550,000 to $600,000 annually |
| Competitive Position |
Holds approximately 65% market share in its segment |
| Growth Drivers |
Rare disease treatment growth, new indications |
| Price Trend |
Modest annual increases, with potential for stabilization |
Key Takeaways
- Ravulizumab remains the dominant complement inhibitor in the rare disease space.
- Its high valuation stems from targeted indications and limited biosimilar competition.
- Market growth is driven by accumulating diagnoses and expanded use outside initial indications.
- Prices are expected to rise modestly over the next five years, influenced by clinical and regulatory developments.
- Competitive pressures from biosimilars are minimal currently but could increase over time.
FAQs
-
What accounts for the high price of Ravulizumab?
The drug's complex manufacturing process, targeted rare disease indications, and limited competition justify its premium pricing.
-
How will biosimilar entry affect prices?
Biosimilar development faces regulatory and scientific challenges, leading to delayed entry and limited immediate price impacts.
-
Are there any upcoming indications that could expand this market?
Yes, ongoing clinical trials explore Ravulizumab for conditions like general systemic complement activity, potentially broadening its use.
-
What are reimbursement prospects for this drug?
Payers recognize rare disease treatments' value; however, negotiations often involve substantial discounts, affecting net revenues.
-
What are the main risks affecting future pricing?
Regulatory hurdles, biosimilar competition, reimbursement caps, and market saturation pose risks to maintaining current price levels.
References
[1] IQVIA. (2023). Global Oncology Market Report.
[2] U.S. Food & Drug Administration. (2020). Ultomiris (Ravulizumab-cwvz) Approval Documentation.
[3] EvaluatePharma. (2022). Pharmaceutical Price and Market Forecasts.
