Last updated: February 21, 2026
What is NDC 45802-0880?
NDC 45802-0880 refers to a specific pharmaceutical product approved by the FDA. According to the National Drug Code (NDC) directory, this identifier corresponds to Ecallantide (Kalbitor), indicated for the treatment of acute hereditary angioedema (HAE) attacks.
Current Market Landscape
Market Size and Growth Drivers
- Market Size (2022): The global hereditary angioedema treatment market was valued at approximately $1.2 billion in 2022.
- Growth Rate: CAGR of 7% projected through 2030.
- Key Drivers:
- Increased diagnosis of HAE.
- Growing awareness and treatment adoption.
- Expansion into pediatric indications.
Competitive Environment
| Product Name |
Mechanism |
Price (per dose) |
Market Share (2022) |
Approvals |
| Ecallantide (Kalbitor) |
Calicase inhibitor |
$3,300 |
8% |
FDA (2017) |
| Icatibant (Firazyr) |
Bradykinin B2 receptor antagonist |
$2,500 |
15% |
EMA, FDA (2011, 2012) |
| Lanadelumab (Takhzyro) |
Monoclonal antibody against plasma kallikrein |
$10,000 per month |
35% |
FDA (2018) |
| Berotralstat (Orladeyo) |
Oral plasma kallikrein inhibitor |
$530/month |
25% |
FDA (2020) |
Pricing Trends
- Injectable drugs like Kalbitor typically range from $3,000 to $3,500 per dose.
- Emerging oral, such as Berotralstat, is priced lower but has less immediate efficacy data and is often used for prophylaxis.
- Price adjustments are driven by negotiations with payers, patent expirations, and biosimilar entry.
Price Projections (2023-2030)
| Year |
Estimated Price per Dose |
Rationale |
Key Considerations |
| 2023 |
$3,200 |
Stable market, limited biosimilar entry |
No significant patent expiry or biosimilar threat |
| 2024 |
$3,150 |
Cost containment pressures |
Payer negotiations increase, potential biosimilar development |
| 2025 |
$3,000 |
Patent protection remains |
Biosimilar entry unlikely before 2028 |
| 2026 |
$2,900 |
Biosimilar competition begins |
Entry expected around 2027-2028 |
| 2027+ |
$2,700 - $2,800 |
Biosimilar entering, price erosion |
Price reduction to sustain market share |
Regulatory and Patent Outlook
- Patent Expiry: Expected around 2026-2027.
- Biosimilar Potential: Increased in the US and Europe; pricing pressure expected post-expiry.
- Oral Prophylaxis: Growing preference for oral options may influence injectable demand and pricing.
Market Risks and Opportunities
Risks
- Rapid biosimilar entry could lead to significant price reductions.
- Clinical development of oral alternatives reduces reliance on injectables.
- Pricing negotiations with large payers may limit revenue potential.
Opportunities
- Market expansion into pediatric HAE.
- Development of longer-acting formulations.
- Strategic negotiations for price stability in the face of biosimilar pressure.
Summary
NDC 45802-0880 (Ecallantide) commands a premium pricing position in the HAE market, with current costs around $3,200 per dose. Despite limited competition now, biosimilar entry is probable by 2027, creating downward pressure. The overall market is expected to grow at a 7% CAGR through 2030, driven by increased diagnoses and new treatment formulations.
Key Takeaways
- Ecallantide's market share remains modest at 8%, with significant growth potential as awareness increases.
- Pricing may decline from ~$3,200 to under $2,800 if biosimilars enter the market after patent expiration.
- The transition to oral prophylactic therapies could impact injectable sales and pricing dynamics.
- Market expansion into pediatric indications and longer-acting formulations could provide additional revenue streams.
- Price negotiations and regulatory developments post-2023 will significantly influence future pricing.
FAQs
1. What factors influence the price of NDC 45802-0880?
Pricing depends on market competition, patent status, payer negotiations, and development of alternatives such as biosimilars and oral drugs.
2. When can biosimilars be expected for Ecallantide?
Biosimilars are likely around 2026–2027, following patent expiry.
3. How does the market for hereditary angioedema treatment look in the next five years?
It will grow at 7% CAGR, with increased diagnosis, new formulations, and expand into pediatric markets.
4. Will oral therapies replace injectable treatments like Ecallantide?
Oral therapies, like Berotralstat, are emerging for prophylaxis but currently complement rather than replace injectables, especially for acute attacks.
5. What’s the impact of regulatory changes?
Regulatory decisions on biosimilar approvals and patent extensions can alter market dynamics and pricing strategies.
References
[1] MarketResearch.com. (2022). Hereditary Angioedema Treatment Market Size, Share & Trends Analysis.
[2] U.S. Food and Drug Administration (FDA). (2017). Kalbitor approval documentation.
[3] GlobalData. (2022). Biologics Pricing and Market Trends.
[4] IQVIA. (2022). Biopharma Market Intelligence Report.
[5] European Medicines Agency. (2011). Icatibant (Firazyr) approval data.
