Last updated: February 20, 2026
What is the Drug NDC 51672-4037?
NDC 51672-4037 corresponds to Ravulizumab-cwvz (brand name: Ultomiris). It is a monoclonal antibody used primarily for complement-mediated rare diseases such as paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and generalized myasthenia gravis (gMG).
Market Overview
Indications and Patient Population
- PNH: Approximately 3,000 patients in the U.S., primarily adults.
- aHUS: Estimated 600-700 patients globally, with a significant portion in the U.S.
- gMG: Around 80,000 patients nationwide, with a subset eligible for Ravulizumab.
Competitive Landscape
- Eculizumab (Soliris): Established leader in complement inhibition.
- Ravulizumab (Ultomiris): Longer half-life allows less frequent dosing—every 8 weeks versus weekly or biweekly for Soliris.
- Other Agents: Emerging therapies in development, but none with equivalent approval status or market penetration yet.
Market Size & Growth Rate
| Indicator |
Value |
Source |
| U.S. PNH prevalence |
3,000 patients |
[1] |
| U.S. aHUS prevalence |
700 patients |
[2] |
| U.S. gMG prevalence |
80,000 patients |
[3] |
| Annual spending on complement inhibitors (globally) |
$3.5 billion (2019) |
[4] |
| Estimated growth rate (2021-2026) |
7% per year |
[5] |
Patent and Market Exclusivity
- Pulled from the original FDA approval in 2018; patent protections extend until 2030-2035.
- Key patents prevent biosimilar entry until at least 2030.
Price Analysis
Current Pricing
- U.S. Wholesale Acquisition Cost (WAC) for Ravulizumab: approximately $463,000 annually for a typical adult dose.
- Average dose: 300 mg every 8 weeks; typical patient receives about 1,600 mg per dose.
| Parameter |
Value |
Source |
| Cost per 300 mg dose |
~$7,000 |
[6] |
| Annual cost (average patient) |
~$463,000 |
[7] |
Pricing Compared to Competitors
| Drug |
Cost (Annual) |
Dosing Frequency |
Notes |
| Soliris (Eculizumab) |
~$500,000–$700,000 |
Weekly/biweekly, weight-based |
Slightly higher or comparable to Ravulizumab |
| Ultomiris (Ravulizumab) |
~$463,000 |
Every 8 weeks |
Lower overall cost due to longer dosing interval |
Reimbursement Trends
- Medicare/Medicaid and private payers have negotiated discounts.
- Actual net prices are estimated 10-15% lower than WAC due to rebates and discounts.
Price Projection for the Next 5 Years
| Year |
Projected Price |
Factors Influencing Price |
| 2023 |
~$463,000 |
Current pricing with no significant change |
| 2024 |
~$460,000 |
Slight decrease expected due to payer pressure and competitive policies |
| 2025 |
~$455,000 |
Possible incremental discounts; patent protections remain intact |
| 2026 |
~$450,000 |
Intensified price negotiations; patent exclusivity continues |
| 2027+ |
~$440,000–$460,000 |
Biosimilar entry prevented until at least 2030, maintaining high prices |
Potential Market Dynamics Impacting Price
- Biosimilar Entry: Not anticipated before 2030; patent expiration delays competition.
- Regulatory Changes: Price control policies could pressure discounts.
- Advances in Therapies: New treatments or approaches could diminish demand or provide alternatives, destabilizing prices.
Key Takeaways
- NDC 51672-4037 (Ravulizumab-Ultomiris) is a leading therapy for several rare complement-mediated diseases.
- Its long dosing interval gives it a competitive advantage over earlier therapies like Soliris.
- Current WAC price is approximately $463,000 annually.
- Price stability expected until 2030 due to patent protection and lack of biosimilars.
- Adoption rates and reimbursement policies will influence actual effective prices.
FAQs
1. What is the primary clinical advantage of Ravulizumab over Soliris?
Its longer half-life reduces dosing frequency from weekly or biweekly to every 8 weeks, lessening treatment burden.
2. When could biosimilars potentially enter the market?
Biosimilars are unlikely before patent expiration, estimated around 2030–2035, depending on jurisdiction.
3. How do discounts and rebates influence the net price?
Rebates reduce the net price by approximately 10–15%; actual paid costs are often lower than WAC.
4. What factors could drive future price reductions?
Increased competition, policy reforms, and biosimilar development are key factors.
5. How does the market size influence pricing strategies?
Limited patient populations allow for high per-unit prices; expanding indications could pressure prices downward.
References
-
Parker, C., et al. (2020). Prevalence of Paroxysmal Nocturnal Hemoglobinuria. Blood.
-
Noris, M., & Bierzynska, A. (2021). Epidemiology of aHUS. Kidney International.
-
Läubli, H., et al. (2018). Myasthenia Gravis prevalence. Neurology.
-
Smith, J. (2019). Global Market for Complement Inhibitors. Pharmaceutical Technology.
-
MarketsandMarkets. (2021). Biologic Market Growth Forecast.
-
Drug Channels Institute. (2022). Cost Analysis of Monoclonal Antibodies.
-
CMS Pricing Data. (2022). Medicare Part B Drug Pricing Report.
