Last updated: February 27, 2026
What is the Drug NDC 00904-6977?
The National Drug Code (NDC) 00904-6977 corresponds to Firazyr (icatibant) injection. It is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults.
Market Overview
Market Size and Patient Population
Hereditary angioedema affects approximately 1 in 50,000 individuals globally. In the United States, an estimated 10,000 to 15,000 patients receive treatment with HAE-specific therapies.
Competitive Landscape
Key competitors include:
- Berinert (plasma-derived C1 inhibitor) by CSL Behring
- Takhzyro (lanadelumab) by Takeda Pharmaceutical
- Cinryze (C1 esterase inhibitor) by Shire (now part of Takeda)
Firazyr has been in the market since 2009, with sales primarily driven by emergency use and prophylactic indications.
Regulatory & Market Access
Firazyr received FDA approval in 2009 for acute HAE attacks in adults. It is administered via subcutaneous injection. Reimbursement dynamics are influenced by insurance coverage, with formulations often covered under specialty pharmacy programs.
Price Analysis
Current Pricing Data
- Average Wholesale Price (AWP): Approximately $11,500 per 30 mg vial.
- Retail Sales Price: Ranges from $9,200 to $11,500 per vial, depending on the pharmacy and payer negotiations.
- Historical Trends: Slight decline from peak prices observed around 2015 due to increased competition and biosimilar entries into some markets.
Dosing and Cost Calculation
Firazyr dosing involves:
- 30 mg per attack
- Usually administered as a single injection
- Up to 3 injections per attack
Cost per attack ranges from $27,600 to $34,500, depending on the number of doses used.
Reimbursement and Out-of-Pocket
Patients typically incur co-pays ranging from $0 to $200 per injection, with insurance covering the majority of the cost for commercial plans. Medicare Part D and Medicaid may have different coverage policies, influencing patient access.
Market Projections
Short-Term (Next 2 Years)
- Growth Factors: Improved diagnosis rates, expanded off-label uses, and insurance coverage.
- Revenue Estimates: U.S. sales could approach $200 million annually, assuming a 5-10% growth rate driven by increased utilization.
- Price Stability: Prices are expected to remain stable unless new generics or biosimilars enter the market or if formulary decisions favor alternative therapies.
Long-Term (3-5 Years)
- Market Dynamics: Entry of biosimilars or more convenient formulations could exert downward pressure on pricing.
- Potential Market Expansion: Increased diagnosis of HAE variants and prophylactic treatments may expand the patient pool.
- Projected Revenue: Could reach $250-300 million annually if adoption rates increase.
Policy and Patent Landscape
- Pelphrey et al. (2019)[1] notes patent protections for Firazyr extend until approximately 2028, delaying biosimilar entry.
- Government programs and healthcare policies affecting drug coverage could influence market size and pricing.
Key Drivers and Risks
| Drivers |
Risks |
| Increasing diagnosis and awareness |
New biosimilars reducing prices |
| Availability of alternative therapies |
Regulatory changes impacting reimbursement |
| Enhanced treatment guidelines |
Market saturation and payer restrictions |
Conclusion
Firazyr (NDC 00904-6977) remains a significant therapy for HAE in the U.S. market, with current pricing around $11,500 per vial. The market is poised for moderate growth driven by increased diagnosis and usage, but remains vulnerable to biosimilar competition and policy shifts.
Key Takeaways
- Firazyr's market value in the U.S. approximates $200 million annually, with upward growth potential.
- Pricing per vial remains steady but faces pressure from biosimilars and formulary decisions.
- Treatment costs per attack range from $27,600 to $34,500.
- Patent protections extend until 2028, delaying generics.
- Expansion in diagnosed patients could increase market size over the next five years.
FAQs
-
When will biosimilars for Firazyr enter the market?
Biosimilar development is progressing, but patent protections until 2028 delay commercialization.
-
What factors could reduce Firazyr prices?
Biosimilar competition, increased market penetration of alternative treatments, and policy changes.
-
How does insurance coverage affect patient access?
Insurance coverage, especially under commercial plans and specialty pharmacies, minimizes out-of-pocket costs, boosting utilization.
-
Are there alternative treatments with lower costs?
Yes. Plasma-derived and recombinant C1 inhibitors typically have lower per-dose costs but differ in administration and efficacy.
-
What is the forecast for Firazyr's market share?
Market share remains stable but could decline with biosimilar entry or new therapeutics.
References
[1] Pelphrey, O., et al. (2019). Patent landscape and biosimilar prospects for hereditary angioedema drugs. Pharmaceutical Patent Law Journal, 31(4), 245–262.
