Last updated: February 15, 2026
What is the market status of drug NDC 59676-0575?
NDC 59676-0575 corresponds to Ecallantide (Kalbitor), a drug approved by the FDA for the treatment of acute attacks of hereditary angioedema (HAE). The drug primarily targets rare genetic conditions characterized by episodic swelling. The market for hereditary angioedema treatments has grown, driven by increased diagnosis and improved awareness.
How large is the current market for Ecallantide?
In 2022, the US market for hereditary angioedema treatments was valued at approximately $700 million. Ecallantide’s share is estimated at $125 million, based on sales data from IQVIA and other market research sources.
What are the key drivers influencing the market?
- Regulatory approvals for additional indications.
- New formulations or delivery methods.
- Competitive landscape, including Bradykinin pathway inhibitors like icatibant (Firazyr) and C1-inhibitor products (Berinert, Haegarda).
How does Ecallantide compare with competitors?
| Product |
Type |
Approval Year |
Approximate 2022 US Sales |
Administration |
Market Share (%) |
| Kalbitor (Ecallantide) |
Recombinant plasma kallikrein inhibitor |
2009 |
$125M |
Subcutaneous injection (3 times per attack) |
15% |
| Firazyr (Icatibant) |
Bradykinin B2 receptor antagonist |
2011 |
$400M |
Subcutaneous injection (single dose) |
57% |
| Cinryze / Haegarda |
C1-inhibitor concentrates |
2008 / 2015 |
$250M |
Intravenous / Subcutaneous |
28% |
Ecallantide holds a niche position, with limited market penetration compared to Firazyr, which dominates the HAE acute treatment space.
What are the price projections for Ecallantide?
The average wholesale price (AWP) for Ecallantide is approximately $3,200 to $3,400 per dose. Treatment involves three doses during an attack, totaling roughly $9,600 to $10,200 per attack.
Future price trends depend on several factors:
- Pricing negotiations and payer policies: Insurance coverage influences obtainable prices.
- Potential for biosimilar or generic entry: No biosimilars currently exist for Ecallantide.
- Development of new formulations: Subcutaneous delivery innovations could reduce costs.
Based on historical pricing patterns, the price per dose has remained relatively stable but could increase by 2-3% annually, driven by inflation and R&D costs. Wholesale prices could reach approximately $3,500 per dose by 2025.
What are the revenue forecasts?
Assuming an estimated annual attack volume of 125,000 in the US (based on epidemiology data from the US Hereditary Angioedema Association), and Ecallantide's market share at 15%, potential annual revenue could be:
[
125,000 \text{ attacks} \times 15\% \text{ market share} \times \$10,000 \text{ per attack} = \$187.5 million
]
If market share grows to 20% with increased adoption, revenues could approach $250 million annually.
What regulatory or policy effects could impact pricing?
- FDA approval for new indications may expand demand but could pressure prices downward.
- CMS reimbursement policies can influence profit margins.
- Legislation on drug pricing transparency might lead to price caps or discounts.
How might market dynamics evolve?
- Emerging therapies — especially oral or longer-acting drugs — might erode Ecallantide's market share.
- Biotech innovations — such as gene therapy or longer-lasting formulations — could reshape the treatment landscape over the next 5-10 years.
- Market consolidation and payer negotiations** will influence net prices.
Summary
Ecallantide (NDC 59676-0575) faces stiff competition from similar therapies, holding a niche segment primarily driven by existing patient preferences and provider familiarity. Stability in wholesale pricing is expected, with modest growth projections. The total addressable market in the US remains around $125-$200 million, with future gains contingent on market expansion, pricing strategies, and new therapeutic innovations.
Key Takeaways
- Ecallantide's US sales are approximately $125 million as of 2022.
- The average price per dose is around $3,200–$3,400; treatment involves three doses.
- Market share is estimated at 15%, with potential growth to 20%.
- Market growth depends on increased diagnosis, expanded indications, and competitive developments.
- Future price increases are limited by payer negotiations and regulatory factors.
FAQs
1. What is the primary use of NDC 59676-0575?
Ecallantide is used to manage acute attacks of hereditary angioedema.
2. Could prices for Ecallantide decline in the future?
Yes, through payer negotiations, increased competition, or biosimilar entry.
3. What are the main competitors to Ecallantide?
Firazyr (icatibant), Cinryze, Haegarda, and other C1-inhibitor products.
4. How many attacks are treated annually in the US?
Approximate estimates suggest around 125,000 attacks annually, based on epidemiological data.
5. Will new therapies impact Ecallantide's market share?
Yes, especially oral or longer-acting treatments that could offer convenience or cost benefits.
Sources:
[1] IQVIA. US Prescription Sales Data, 2022.
[2] FDA. Drug approvals and indications.
[3] US Hereditary Angioedema Association Reports, 2022.
