Last updated: February 24, 2026
What is the Drug Corresponding to NDC 00591-2641?
NDC 00591-2641 corresponds to Takhzyro (lanadelumab), a monoclonal antibody approved for the prevention of hereditary angioedema (HAE) attacks in adult and adolescent patients aged 12 years and older. It was approved by the Food and Drug Administration (FDA) in August 2018.
Market Overview
Therapeutic Area
Hereditary angioedema is a rare genetic disorder characterized by recurrent episodes of swelling. The global HAE market predominantly includes biologics like lanadelumab, C1 esterase inhibitors, and kallikrein inhibitors.
Current Market Size
The global HAE treatment market was valued at approximately $1.1 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of around 7% through 2028, driven by increased diagnosis rates, expanded indications, and novel biologics (MarketWatch, 2023).
Competitive Landscape
- Shire / Takeda: C1 esterase inhibitors (e.g., Cinryze, Haegarda)
- BioCryst: Kallikrein inhibitor (Orladeyo)
- Takeda: Lanadelumab (Takhzyro)
- Cesara: Emerging therapies in development
Lanadelumab holds a significant market share due to its subcutaneous administration and favorable efficacy profile.
Pricing Analysis
Current Market Price
As of late 2023, the average wholesale acquisition cost (WAC) for Takhzyro is approximately $675,000 annually per patient. The pricing is based on a monthly dose of 300 mg administered subcutaneously, with each dose costing roughly $56,250.
| Parameter |
Details |
| Cost per dose |
~$56,250 |
| Doses per month |
1 |
| Annual cost per patient |
~$675,000 |
Cost Breakdown & Comparison
| Therapy |
Dosing |
Annual Cost |
Administration Route |
Market Share |
| Takhzyro (lanadelumab) |
300 mg subcutaneous every 2 weeks |
~$675,000 |
Subcutaneous |
Leading biologic for HAE |
| C1 esterase inhibitors (Cinryze, Haegarda) |
IV infusions or SC |
$400,000–$600,000 |
Intravenous / SC |
Established competitors |
| Orladeyo (berotralstat) |
Oral daily |
~$300,000 |
Oral |
Competitive alternative |
Lanadelumab's premium price reflects its market positioning as a long-acting biologic with convenient subcutaneous dosing.
Price Projections and Market Dynamics
Short-term (1-3 years)
- Competition from oral agents like Orladeyo may pressure prices.
- Manufacturers could introduce discounts or patient assistance programs to expand coverage.
- Price for lanadelumab may stabilize or slightly decline to remain competitive, potentially averaging around $650,000 annually.
Medium to Long-term (3-7 years)
- Biosimilar development is less feasible for monoclonal antibodies due to complex manufacturing but could impact pricing if biosimilars or biosimilar-like therapies gain approval.
- Introduction of next-generation biologics with improved efficacy or dosing may cause price adjustments.
- Price could decrease to approximately $600,000 annually, influenced by market competition and healthcare payer negotiations.
Key Factors Influencing Price Changes
- Regulatory approvals expanding indications
- EP reimbursement policies impacting out-of-pocket costs
- Market entry of competitors with comparable or superior efficacy
- Manufacturing advances reducing production costs
Revenue Projections
Assuming continued increase in patient adoption owing to rising awareness and diagnosis:
| Year |
Estimated Patients |
Market Share |
Revenue (millions USD) |
| 2023 |
2,000 |
60% |
~$1.35 billion |
| 2025 |
3,500 |
65% |
~$2.3 billion |
| 2028 |
5,000 |
70% |
~$3.5 billion |
Note: These figures are projections based on current market trends and drug adoption rates.
Summary and Conclusions
- The current price for NDC 00591-2641 (Takhzyro) is approximately $675,000 annually.
- Market share remains strong within HAE biologic therapies, but oral competitors threaten pricing stability.
- Short-term prices are likely to plateau, with potential slight reductions driven by market pressures.
- Long-term prices could decrease as newer therapies and payer negotiations impact the market dynamics.
Key Takeaways
- Takhzyro is priced at a premium relative to alternative therapies due to its convenience and efficacy.
- The overall HAE treatment market is expected to grow at around 7% CAGR, supporting revenue expansion.
- Competitive pressures and new therapy approvals could influence future price adjustments.
- Payer and manufacturer strategies will determine pricing trends over subsequent years.
- Revenue projections indicate widespread adoption and significant market opportunity for agents like Takhzyro.
FAQs
1. What factors influence the pricing of biologics like lanadelumab?
Market competition, manufacturing costs, regulatory environment, and payer negotiations drive biologic pricing.
2. Are biosimilars expected to enter the HAE biologic market?
Biosimilar development for monoclonal antibodies faces scientific and regulatory challenges, making entry less likely in the near future.
3. How does Takhzyro compare cost-wise to other HAE treatments?
It is priced higher than oral options like Orladeyo but offers advantages in dosing frequency and administration route.
4. What is the potential impact of new therapies on Takhzyro’s price?
New therapies could lead to price competition or formulary inclusion shifts, possibly reducing Takhzyro’s price.
5. How does healthcare reimbursement influence drug pricing?
Reimbursement policies can limit prices or increase patient access through discounts, impacting manufacturer revenues.
References
[1] MarketWatch. (2023). Hereditary Angioedema Market Size, Share & Trends Analysis.
[2] FDA. (2018). FDA approves Takhzyro to prevent hereditary angioedema attacks.
[3] IQVIA. (2022). Biologic treatment market data.
