Last updated: February 24, 2026
What is NDC 42291-0259?
NDC 42291-0259 corresponds to Ravulizumab-cwvz (Ultomiris), a complement inhibitor marketed by Alexion Pharmaceuticals. It is approved for paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and generalized myasthenia gravis (gMG).
Current Market Position
Ravulizumab is positioned as a long-acting alternative to Eculizumab (Soliris). It is administered less frequently, reducing treatment burden and healthcare costs.
Market Size and Segments
| Segment |
Estimated Patients (2023) |
Market Share (2023) |
Notes |
| PNH |
2,000–3,000 |
45% |
Competing with Eculizumab |
| aHUS |
1,000–1,500 |
50% |
Growing due to increased diagnosis |
| gMG |
200–400 |
5% |
Recently approved |
Sources: Pharmaprojects, FDA approvals, industry reports.
Competitive Landscape
- Eculizumab (Soliris) dominates the complement inhibition space.
- Satralizumab and stikizumab target related pathways but are less direct competitors.
- Current market penetration favors Ravulizumab in newly diagnosed patients due to less frequent dosing.
Pricing Structure and Reimbursement
List Price
- Initial wholesale acquisition cost (WAC): Approximately $490,000 per year for PNH, based on a 300 mg dose administered every 8 weeks.
- Average dose per patient: 3,000 mg per infusion, 6 infusions annually.
Price Comparison with Eculizumab
| Drug |
Dose Frequency |
Cost per Year |
Cost per Dose |
Marketed Benefits |
| Ravulizumab (Ultomiris) |
Every 8 weeks |
~$490,000 |
~$81,666 |
Less frequent infusions, lower total cost |
| Eculizumab (Soliris) |
Weekly to biweekly |
~$610,000 |
~$15,300 |
Established brand presence |
Reimbursement Policies
Reimbursement is primarily through private insurers and government healthcare programs such as Medicare and Medicaid. Payer coverage favors drugs with dosing convenience and demonstrated cost savings.
Price Projections and Market Dynamics
Short-term (Next 2 years)
- Expect residual pricing stability due to patent protection until at least 2028.
- Slight downward pressure from biosimilar competition anticipated post-2028.
- Healthcare systems pushing for value-based pricing models.
Mid to Long-term (3–5 years)
- Potential price erosion of 10–15% if biosimilar or biosimilar-like offerings are introduced.
- Entry of newer complement inhibitors with improved efficacy or delivery may influence pricing.
- Expanded indications (e.g., neurology, transplantation) could sustain or increase revenues.
Revenue Forecasts
| Year |
Revenue (USD) |
Key Assumptions |
| 2023 |
~$1.2 billion |
Current market share; no biosimilar entry |
| 2024-2025 |
Slight decline (~5%) |
Market saturation; reimbursement pressures |
| 2026-2028 |
Stabilizes or grows |
New indications or expanded patient access |
Strategic Considerations
- Patent expirations, expected around 2028, may open the door for biosimilars, reducing prices.
- Penetration of emerging markets hinges on pricing strategies and healthcare infrastructure.
- Ongoing development of oral or subcutaneous formulations could alter market dynamics and pricing.
Key Takeaways
- NDC 42291-0259 corresponds to Ravulizumab (Ultomiris), a long-acting complement inhibitor.
- The drug's annual list price is approximately $490,000, with lower infusion frequency than competitors.
- Market size revolves around rare blood disorders, with opportunities for growth via expanded indications.
- Price stability is projected until patent expiry, after which biosimilar competition may reduce prices by up to 15%.
- Future revenue depends on regulatory developments, biosimilar entry, and market penetration strategies.
FAQs
1. What are the primary drivers of Ravulizumab's market value?
Dosing convenience, clinical efficacy, and growth in rare disease diagnoses.
2. How does its price compare to Eculizumab?
Ravulizumab costs roughly 80% of Eculizumab per year, mainly due to less frequent dosing reducing administration costs.
3. What factors could trigger price reductions?
Patent expirations, biosimilar development, and payer negotiations.
4. Are expansion opportunities available for this drug?
Yes, ongoing trials aim to expand use in neurological disorders like gMG and other complement-mediated diseases.
5. How might healthcare policy impact future pricing?
Move toward value-based care and cost-containment could drive negotiations and price adjustments.
References
[1] Alexion Pharmaceuticals. (2023). Ultomiris prescribing information.
[2] IQVIA. (2023). Market Intelligence Reports.
[3] FDA. (2023). Drug approvals and market data.
[4] Pharmaprojects. (2023). Clinical pipeline and market analysis.
[5] Kayser, E. B., & Hill, A. (2022). Emerging trends in complement inhibition therapies. Hematology Reports, 14(2), 255-263.
