Last updated: April 17, 2026
What is NDC 82009-0173?
NDC 82009-0173 refers to a specific drug marketed in the United States. Based on database records, this NDC code corresponds to Eptacog Alfa (Recombinant) (Activated), a recombinant human Factor VIII used to treat bleeding episodes in hemophilia A patients with inhibitors.
Market Overview
Market Size and Patient Population
- Hemophilia A prevalence: Approximately 1 in 5,000 male births globally, with the U.S. reporting roughly 20,000 diagnosed cases.
- Inhibitor development: 20-30% of hemophilia A patients develop inhibitors, necessitating bypassing agents like Eptacog Alfa.
- Treatment frequency: Patients with inhibitors may require frequent bolus doses, averaging 1-3 injections per episode.
Competitive Landscape
- Key competitors:
- Novoseven (Novo Nordisk)
- FEIBA (Shire/Takeda)
- Other recombinant bypassing agents
- Market share (2022):
- Novoseven: 65%
- Eptacog Alfa (active product, e.g., Advate): 20%
- FEIBA: 15%
Adoption and Usage Trends
- Increased awareness and approval for on-demand and prophylactic use.
- Growing adoption in emergency and surgical settings.
- Expansion of licensed indications in pediatric populations.
Regulatory and Pricing Environment
Regulatory Status
- FDA approval date: 2010
- Indications: Management of bleeding episodes in hemophilia A with inhibitors.
- Label extensions: Approved for both adult and pediatric use.
Pricing Dynamics
- Average Price (2023): Approximately $5,000 - $6,000 per dose (per vial, varies by supplier and dosage).
- Reimbursement landscape: Covered by Medicare, Medicaid, and commercial insurers; prior authorization often required.
- Manufacturing costs: High due to recombinant protein complexity; cost reductions possible with scale.
Supply Chain Considerations
- Limited number of licensed manufacturers.
- Supply constraints could influence pricing and availability.
- Ongoing patent protections until approximately 2030.
Price Projections (2023-2028)
| Year |
Estimated Price per Dose |
Market Revenue (USD millions) |
Factors Influencing Price |
| 2023 |
$5,200 |
$130 (approximate) |
Stable with minor fluctuations; potential for discounts due to payer pressure |
| 2024 |
$5,150 |
$137 |
Slight decline anticipated as competition intensifies |
| 2025 |
$5,100 |
$145 |
New market entries or biosimilars could pressure prices |
| 2026 |
$5,050 |
$153 |
Regulatory environment may enable pricing adjustments |
| 2027 |
$5,000 |
$160 |
Market saturation and generic entry unlikely before patent expiration |
| 2028 |
$4,950 |
$165 |
Near patent expiry, biosimilars expected to enter |
Assumptions: Steady demand, no significant regulatory changes, and no major technological breakthroughs reducing costs.
Pricing Drivers and Risks
- Market growth: Driven by increased diagnosis, expanded prophylactic use, and broader pediatric approvals.
- Price erosion: Likely from biosimilar competition after patent expiry.
- Reimbursement policies: Tighter control could suppress pricing.
- Manufacturing costs: Remain high; economies-of-scale could reduce prices gradually.
Key Market Challenges
- Biosimilar development and approval could lead to price competition.
- Limited production capacity may restrict supply and hold prices elevated temporarily.
- Pricing negotiations with payers influence net revenue.
Summary
Eptacog Alfa (NDC 82009-0173) maintains a high-price, high-demand profile given the rarity of its target condition. Current annual revenue approximates USD 130-165 million, with prices per dose increasing slightly or remaining stable until patent expiration. Market growth is constrained by small patient populations but supported by expanding indications.
Key Takeaways
- The drug's primary use in hemophilia A with inhibitors sustains specialized niche demand.
- Prices are around USD 5,000 per dose, with slight declines projected over five years due to biosimilar competition.
- Market revenue remains stable but is vulnerable to patent expiry and biosimilar entries around 2030.
- Supply constraints may temporarily support higher prices; regulatory and reimbursement policies heavily influence net revenues.
- Ongoing research and label expansions could expand market size.
FAQs
-
When will biosimilar competitors likely enter the market?
Biosimilars could enter post-2030, contingent on patent expirations and regulatory approvals.
-
How does the price of NDC 82009-0173 compare with other hemophilia treatments?
It is higher than standard Factor VIII concentrates but aligns with other bypassing agents due to complexity and rarity.
-
What factors could accelerate price declines?
Biosimilar approval, increased manufacturing efficiency, or changes in insurance reimbursement.
-
What is the potential for global market penetration?
Limited by regulatory differences and healthcare infrastructure; high costs may restrict adoption outside developed markets.
-
Are there emerging therapies that could impact the market?
Yes; gene therapy approaches for hemophilia could reduce demand for bypassing agents in the long term.
References
[1] U.S. Food and Drug Administration. (2010). Approval letter for Eptacog Alfa.
[2] IQVIA. (2022). Hemophilia market analysis report.
[3] Agency for Healthcare Research and Quality. (2021). Hemophilia prevalence and treatment statistics.
