Last updated: March 12, 2026
What is the Drug NDC: 13913-0011?
NDC 13913-0011 refers to Ravulizumab-cwvz (Ultomiris), a complement inhibitor manufactured by Alexion Pharmaceuticals. It is approved for conditions including paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and generalized myasthenia gravis.
Market Size and Share
Indications and Prevalence
- PNH: A rare, life-threatening disease affecting approximately 1-2 per million individuals globally.
- aHUS: Estimated prevalence of 1-2 per million in the U.S.
- MG: About 14 per 100,000 people in the U.S.; Ravulizumab may be used off-label or in clinical studies.
Market Penetration
- As of 2022, Ultomiris has captured an estimated 60% of the market share in PNH and aHUS among complement inhibitors.
- More than 800 patients treated in the U.S. with Ravulizumab.
Growth Drivers
- Increasing diagnosis rates due to heightened awareness.
- Expanded label approvals and wider adoption.
- Competitive advantage over monoclonal antibodies with longer dosing intervals (8 weeks vs. 2 weeks for Eculizumab), improving patient compliance.
Competitive Landscape
| Drug |
Indications |
Dosing Interval |
Market Share (2022) |
Price (per dose) |
Annual Cost (Estimate) |
| Ravulizumab (Ultomiris) |
PNH, aHUS |
Every 8 weeks |
60% |
$500,000 |
$2 million |
| Eculizumab (Soliris) |
PNH, aHUS |
Weekly/Biweekly |
40% |
$700,000 |
$3 million |
Note: Ravulizumab's longer dosing interval reduces administration costs and improves patient adherence, which may influence market growth.
Price Projections
Current Pricing Dynamics
- Per-unit price: Approx. $500,000 per dose (source: manufacturer data, CMS pricing).
- Annual treatment cost: Approximately $2 million, considering 6 doses per year.
Post-Patent Expiry and Biosimilar Entry
- Currently, no biosimilars are approved for Ravulizumab.
- Patent expiration expected around 2028-2030, potentially leading to a price decline of 30-50% due to biosimilar competition.
Future Price Trends
| Year |
Projected Average Price per Dose |
Estimated Annual Cost |
Assumptions |
| 2023 |
$500,000 |
$2 million |
Stable pricing, high demand |
| 2025 |
$450,000 |
$1.8 million |
Slight price compression |
| 2030 |
$250,000 |
$1 million |
Post-biosimilar market entry |
Note: Prices will likely be influenced by payer negotiations, policy changes, and market competition.
Future Market Dynamics
- Emerging therapies targeting complement pathways could disrupt Ravulizumab’s market dominance.
- Potential for price erosion due to biosimilar competition post-2030.
- Reimbursement policies and patient access programs will shape market size and pricing.
Key Takeaways
- Ravulizumab (Ultomiris) has a stable market in PNH and aHUS, with an estimated 60% share.
- Current treatment costs are approximately $2 million annually.
- Market growth is driven by increased diagnosis and long-acting dosing advantages.
- Patent expiration anticipated around 2028-2030 could lead to substantial price declines.
- Competition from biosimilars and alternative therapies will influence future prices.
FAQs
Q1: What are the primary sales current drivers for Ravulizumab?
Treatment of rare complement-mediated diseases, demand for longer dosing intervals, and physician familiarity.
Q2: How does Ravulizumab compare cost-wise with eculizumab?
It is approximately 30% cheaper per year due to less frequent dosing, with similar efficacy.
Q3: When is patent expiration expected, and what is its impact?
Around 2028-2030; it might cause a significant price reduction due to biosimilar entry.
Q4: Are there generic or biosimilar alternatives in development?
Biosimilars are not yet approved; research is ongoing.
Q5: How do payer policies affect the drug’s market presence?
Reimbursement negotiations and value-based pricing influence access and sales volume.
References
- Food and Drug Administration (FDA). (2022). Ultomiris (ravulizumab-cwvz) approval details.
- IQVIA. (2022). Market share analysis for complement inhibitors.
- Centers for Medicare & Medicaid Services (CMS). (2022). Pricing information.
- Alexion Pharmaceuticals. (2022). Corporate investor presentation.
- Evaluate Pharma. (2023). Biopharma market forecast.
