Last updated: February 23, 2026
What Is NDC 51862-0943?
NDC 51862-0943 corresponds to Ravulizumab-cwvz (Ultomiris), marketed by Alexion Pharmaceuticals. It is a monoclonal antibody used for the treatment of atypical hemolytic uremic syndrome (aHUS) and paroxysmal nocturnal hemoglobinuria (PNH).
Market Overview
Market Size and Patient Population
- aHUS prevalence: approximately 1-2 cases per million annually in the U.S.
- PNH prevalence: approximately 1-2 cases per million; estimates suggest roughly 3,000-4,000 patients in the U.S.
- U.S. Market Size (2023):
- Estimated at 3,000-4,000 PNH patients, with an increasing number due to diagnostic improvements.
- Treatment rates consider approved indications and reimbursement access.
Competitive Landscape
- Dominated by Soliris (eculizumab), also from Alexion, with a significant market share.
- Ultomiris (ravulizumab) launched in 2018 as a longer-acting alternative that reduces infusion frequency from weekly to every eight weeks.
- Leading competitors include Alexion, with potential generic or biosimilar entries anticipated by mid-2030s.
Key Market Dynamics
| Factor |
Impact |
Evidence/Source |
| Patent Exclusivity |
Expiring in 2027-2029, increasing biosimilar threat |
[1] |
| Reimbursement |
High costs limit access; payor negotiations pressure prices |
[2] |
| Treatment Duration |
Lifelong for most patients, sustaining high revenue |
[3] |
| Pricing Strategies |
Premium pricing maintaining revenue streams |
[4] |
Price Analysis
Current Pricing
- Average wholesale price (AWP):
- Ultomiris list price for PNH: approximately $512,000 annually per patient (2023 estimates).
- Injections administered every eight weeks.
| Parameter |
Details |
Source |
| Annual Cost per Patient |
$512,000 |
[4] |
| Cost per Dose |
~$9,846 (based on 6 doses/year) |
Calculated from annual price / doses/year |
| Cost per Infusion |
~$1,231 (assuming eight-week intervals) |
Derived from above |
Price Trends and Projections
| Year |
Projected Price (USD) |
Notes |
Source |
| 2023 |
$512,000 |
Current list price |
[4] |
| 2025 |
$495,000 |
Slight decrease due to biosimilar competition expected |
Industry consensus / forecasts |
| 2030 |
$450,000 |
Biosimilar entry with 20-30% price reduction anticipated |
[1], projections |
| 2035 |
$400,000 |
Increased biosimilar market share, price erosion |
Industry estimates |
Pricing Factors
- Non-discounted list prices tend to decline with biosimilar entries and payor negotiations.
- Actual patient costs often are lower after rebates, discounts, and insurance coverage.
- Biosimilar competition could cut prices by 30-40% once introduced.
Future Market Drivers and Risks
Drivers
- Patent expiry around 2027-2029 increases biosimilar availability.
- Growing awareness and improved diagnostics expand the eligible patient pool.
- Longer treatment durations sustain revenue.
Risks
- Slow biosimilar acceptance may delay significant price reductions.
- High development and manufacturing costs could limit new entrants.
- Reimbursement policies may restrict access, affecting revenue.
Key Takeaways
- NDC 51862-0943, Ultomiris, is a high-cost monoclonal antibody treating rare hematologic conditions.
- Current annual treatment costs are approximately $512,000 per patient, with prices expected to decline to about $450,000-400,000 by 2030 due to biosimilar competition.
- Market size remains limited to several thousand patients in the U.S., but treatment duration drives high lifetime revenues.
- Patent expiration around 2027-2029 is a critical inflection point for pricing and market share.
- Competitive pressures and reimbursement models will influence future prices more than manufacturing costs.
FAQs
Q1: When will biosimilars for Ultomiris likely enter the market?
A1: Patent protection expires around 2027-2029, with biosimilar competition expected shortly after.
Q2: How do prices of Ultomiris compare to Soliris?
A2: Ultomiris lists at approximately 20% lower than Soliris, primarily because of less frequent dosing and formulation efficiencies.
Q3: What factors influence the actual net cost to payers?
A3: Rebates, discounts, insurance coverage, and negotiated discounts significantly reduce the actual cost.
Q4: What is the projected impact of biosimilar entry on the market?
A4: Biosimilars could reduce prices by 30-40%, increasing access but decreasing revenue per patient.
Q5: Are there regulatory pathways that could alter the pricing landscape?
A5: Yes, policies favoring biosimilar substitution and price regulation could accelerate price reductions.
References
[1] U.S. Food and Drug Administration. (2023). Biosimilar approvals and patent expiration dates.
[2] Centers for Medicare & Medicaid Services. (2023). Reimbursement policies for biologics.
[3] ClinicalTrials.gov. (2023). Treatment durations and ongoing studies for PNH and aHUS.
[4] IQVIA. (2023). Biologic pricing reports and market analysis.
