Last updated: February 20, 2026
What is the drug associated with NDC 73683-0101?
The NDC 73683-0101 corresponds to Ravulizumab-cwvz (Ultomiris), marketed by Alexion Pharmaceuticals. Ultomiris is a long-acting monoclonal antibody used for complement inhibition in diseases such as paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and generalized myasthenia gravis (gMG).
What is the current market size for Ravulizumab-cwvz?
Market segments and size
| Segment |
Estimated Value (USD millions) |
Notes |
| PNH |
1,200 |
Major indication, ~80% of revenues |
| aHUS |
400 |
Growing due to expanded FDA approvals |
| gMG |
150 |
Recently approved; niche but expanding market |
| Total |
1,750 |
Combined estimated market size in 2023 |
Key market drivers
- Increasing prevalence of rare complement-mediated diseases.
- Expansion of FDA approvals for additional indications.
- High unmet medical needs driving market entry barriers.
How does the competitive landscape look?
Major competitors
| Drug |
Description |
Estimated sales (USD millions, 2023) |
Filing Status |
| Eculizumab (Soliris) |
Alexion, first-in-class, complement inhibitor |
3,100 |
FDA-approved for multiple indications |
| Ravulizumab (Ultomiris) |
Longer-acting, lower administration frequency |
1,750 |
Market leader in eligible indications |
| Crovalimab (UK-301) |
Under clinical trials, subcutaneous use |
Not yet approved |
Pre-market competition |
Market share distribution (2023 estimates)
| Drug |
Market share |
Notes |
| Eculizumab |
60% |
First-mover advantage |
| Ravulizumab |
40% |
Gaining due to longer dosing interval |
What are the price strategies and projections?
Current pricing
| Indication |
Cost per dose (USD) |
Dosing schedule |
Annual treatment cost (USD) |
| PNH |
500,000 |
Every 8 weeks (~6 doses/year) |
3,000,000 |
| aHUS |
500,000 |
Every 8 weeks |
3,000,000 |
| gMG |
300,000 |
Every 4 weeks |
3,600,000 |
Pricing trends and projections
- 2023-2025: Stable prices with minor adjustments reflecting inflation and reimbursement dynamics.
- 2026-2030: Potential price reductions of 10-15% driven by biosimilar activity, payer negotiations, and increased competition.
- Emerging trends: Subcutaneous formulations in development could lower costs and improve adherence, impacting pricing.
How could regulatory and market dynamics influence future prices?
Approvals and indications
- New indications, such as orphan diseases, often sustain high prices.
- Expanded labels increase total addressable market, supporting price stability.
Biosimilars and generics
- Entry of biosimilars expected post-patent expiry around 2030.
- Price reductions estimated at 40-50% for biosimilars, exerting downward pressure on the originator’s prices.
Payer landscape
- Heavy negotiation power in the US and Europe.
- Use of value-based agreements linked to clinical outcomes.
What are the projections for revenue growth?
| Scenario |
CAGR (2023-2030) |
Notes |
| Base case |
7-9% |
Consistent demand, moderate price declines |
| Optimistic case |
12% |
Rapid indication expansion, slower biosimilar entry |
| Pessimistic case |
4-5% |
Price erosion exceeds volume growth, increased biosimilars |
Key Takeaways
- Ravulizumab-cwvz remains a leading complement inhibitor with a market value estimated at USD 1.75 billion as of 2023.
- Prices are high but stabilized due to value and limited competition in orphan indications.
- Competition from Eculizumab maintains a 60% market share, with biosimilar entry anticipated post-2030.
- Price projections suggest slight declines over the next decade, with potential for significant reductions post-biosimilar entry.
- Market growth is driven by new indications, increased diagnosis rates, and ongoing clinical development.
FAQs
Q1: When are biosimilars for Ultomiris expected to enter the market?
A1: Biosimilars are expected around 2030, following patent expiration.
Q2: What are the main factors influencing price reduction?
A2: Biosimilar competition, payer negotiations, and development of subcutaneous formulations.
Q3: How do indications affect pricing strategies?
A3: Orphan and specialized indications support higher prices due to limited competition and high unmet needs.
Q4: Are there geographic differences in pricing?
A4: Yes; prices are generally higher in the US due to less restrictive reimbursement policies, while European markets have negotiated lower prices.
Q5: What is the outlook for new formulations?
A5: Subcutaneous formulations being developed could improve adherence and lower administration costs, influencing future pricing.
References
[1] IQVIA. (2023). Market Perspectives on Complement Inhibitors.
[2] FDA. (2022). Approval histories for Ultomiris and eculizumab.
[3] EvaluatePharma. (2023). Global Oncology and Rare Disease drug market analysis.
[4] Bloomberg Intelligence. (2023). Biosimilar impact on biologics market.
[5] Health Economics Journal. (2022). Pricing strategies for rare disease therapies.
