Last updated: February 24, 2026
What Is the Drug Associated with NDC 00536-1421?
NDC 00536-1421 corresponds to Omontys (pegcetacoplan), a complement C3 inhibitor approved for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). It was approved by the FDA in May 2021 and marketed by Apellis Pharmaceuticals.
Market Size and Condition Prevalence
PNH is a rare, acquired hematologic disorder caused by complement system dysregulation leading to hemolysis. The global prevalence is estimated at approximately 5-16 cases per million people.
- U.S. patient population: Roughly 1,000 to 1,500 active patients
- Global patient estimates: 4,000 to 10,000 (WHO estimates)
Key competitors include Soliris (eculizumab) and Ultomiris (ravulizumab), both complement inhibitors from Roche and Alexion, respectively.
Current Market Landscape
| Competitor |
Indications |
Annual Sales (2022) |
Market Share |
Price per Dose (2023) |
Dosing Frequency |
| Soliris (eculizumab) |
PNH, atypical hemolytic uremic syndrome |
$4.4 billion (2022) |
70% |
~$537,000 per year |
Weekly infusions, 2-3 days, IV |
| Ultomiris (ravulizumab) |
PNH, other complement-mediated diseases |
$1.8 billion (2022) |
20% |
~$460,000 per year |
Every 8 weeks, IV |
| Pegetacoplan (Omontys) |
PNH |
Approved in 2021 |
Emerging |
~$300,000 annually (estimated) |
Twice weekly, subcutaneous injection |
Price Projections and Economics
1. Current Pricing
Omontys has a list price of approximately $300,000 annually, based on similar biologic therapies targeting rare diseases with twice-weekly administration.
2. Pricing Trends and Outlook
- Stability in Pricing: Rare disease drugs generally maintain high prices due to small patient populations.
- Potential adjustments: Price reductions are unlikely unless competitive factors (biosimilars, new entrants) emerge.
- Incentives and rebates: Payers increasingly negotiate discounts; net prices typically 10-20% below list prices.
3. Market Penetration and Revenue Estimates (Next 3–5 Years)
| Year |
Estimated Patients Treated |
Revenue (USD Millions) |
Notes |
| 2023 |
300 |
$90 – $120 |
Early adoption phase |
| 2024 |
600 |
$180 – $240 |
Increased clinician familiarity |
| 2025 |
1,000 |
$300 – $400 |
Maximal prescriber uptake |
Growth assumptions:
- Market capture reaches approximately 50% of available patients within five years.
- Price remains stable at ~$300,000 annually.
- Competition from existing large-molecule therapies may suppress growth if biosimilars or new entries arrive.
Competitive Dynamics
- Roche's Soliris and Ultomiris hold dominant market share, with prices above $460,000 annually.
- Omontys is positioned as a more convenient subcutaneous option, which might favor patient adherence and provider preference.
- Payers favor drugs with demonstrated cost-effectiveness; Omontys's pricing and efficacy profile will influence formulary access.
Regulatory and Reimbursement Considerations
- Insurance coverage heavily influences utilization.
- As a biologic, rebates and negotiated pricing will likely lower net revenue.
- New indications or expanded approval could drive sales increases.
Strategic Outlook
- Launch phase (2021–2023): Revenue growth limited by awareness and prescriber adoption.
- Expansion phase (2024–2026): Revenue growth accelerates with increased treatment rates.
- Competitive environment: Price remains relatively stable but sensitive to biosimilar development and payer negotiations.
Key Takeaways
- NDC 00536-1421 (Omontys) operates within a small but expanding global PNH market.
- Estimated annual revenue potential is approximately $90 million in 2023, rising to about $400 million by 2025, assuming increased uptake.
- Pricing per patient stays around $300,000 annually, with limited potential for significant reductions without market disruption.
- Competition from Soliris and Ultomiris remains strong; Omontys's ease of use and administration route could offer competitive advantages.
- Market penetration depends on prescriber adoption, payer coverage, and emerging biosimilars/biospecific therapies.
FAQs
What factors influence the price of Omontys?
Market exclusivity, manufacturing costs, payer negotiations, and competition impact pricing. Large payers typically negotiate discounts, reducing net prices.
How does Omontys compare economically to competitors?
Omontys has a lower list price (~$300,000) compared to Soliris (~$537,000) and Ultomiris (~$460,000) but may face barriers from established therapies' clinical convenience and reimbursement.
Could biosimilars or new entrants impact Omontys pricing?
Yes. Entry of biosimilars or novel therapies targeting PNH can reduce prices, especially if they demonstrate comparable efficacy and safety.
What is the projected market growth rate for Omontys?
Approximately 25–30% annually in the next three years, driven by increased diagnosis, prescriber adoption, and patient access.
What strategic moves could enhance Omontys's market share?
Expanding indications, demonstrating cost-effectiveness, and improving treatment convenience could favorably influence uptake and pricing.
References
[1] U.S. Food and Drug Administration. (2021). FDA approves Pegcetacoplan for PNH.
[2] Apellis Pharmaceuticals. (2023). Omontys prescribing information.
[3] IQVIA. (2023). Global Hematology Market Data.
[4] EvaluatePharma. (2022). Oncology and Rare Disease Drug Market Report.
