Last updated: February 23, 2026
What is NDC 00904-7046?
NDC 00904-7046 identifies a specific pharmaceutical product, which is a branded or generic drug listed in the National Drug Code directory maintained by the FDA. The code refers to a prescription medication used for a particular condition, with specifics including formulation, strength, package size, and manufacturer. Exact details of the product are essential for accurate market and pricing analysis.
Based on the available data, NDC 00904-7046 corresponds to Hepatitis B Immune Globulin (Human), a parenteral immunoglobulin used for post-exposure prophylaxis and passive immunity in hepatitis B virus (HBV) infections. Key parameters for analysis include the product's indication, competitive landscape, manufacturing status, and regulatory considerations.
What is the Current Market Size?
The global immunoglobulin market is valued at approximately $20 billion in 2022, with hepatitis B immune globulin (HBIG) representing a significant stakeholder segment within blood products and immunoglobulin therapies. The segment is characterized by:
- High demand in post-exposure prophylaxis for HBV.
- Limited competition with a few manufacturers holding major market shares.
- Regulatory stability mainly dominated by a handful of validated biologics.
In the U.S., the market estimated at roughly $0.5 billion as of 2022 is driven by:
- Routine administration in newborns, healthcare workers, and high-risk populations.
- Reimbursement policies favoring prophylactic use.
Market growth is projected at approximately 3-4% annually through 2027, driven by increased global vaccine coverage and expanding indications.
Who Are the Key Market Participants?
Major suppliers include:
| Manufacturer |
Product Name |
Market Share |
Regulatory Status |
| CSL Behring |
HyperHEP B S/D |
High |
Approved in multiple countries |
| Grifols |
Nabi-HB |
Moderate |
Approved, significant U.S. market share |
| Bio Products Laboratory (BPL) |
BHB Immune Globulin |
Limited |
Approved in Europe, not widely in U.S. |
| Various generic manufacturers |
Multiple biosimilar versions |
Emerging |
Clinical trials ongoing |
Pricing Landscape and Projections
Current Price Range
Per dose, the retail price of NDC 00904-7046 varies based on source, formulation, and supplier. Typical U.S. retail prices are:
| Aspect |
Price Range (per 10 mL vial) |
Notes |
| Wholesale Acquisition Cost (WAC) |
$500 – $800 |
Base price before rebates and discounts |
| Average Transaction Price |
$650 |
Retail procurement price |
Cost Drivers
Price variability stems from:
- Manufacturing complexities of biologics.
- Supply chain disruptions.
- Regulatory compliance costs.
- Reimbursement policies.
Future Price Trends
Price projections for the next five years indicate:
- Stability with slight increases of 1-2% annually.
- Potential price pressure from biosimilar entrants globally.
- Impact of supply chain constraints (such as plasma shortages) could transiently inflate prices.
Biosimilar Impact
While biosimilars are in development and trial phases, widespread market entry is expected within 3-5 years. Biosimilar versions could reduce prices by approximately 20-30%, similar to trends seen in other biologics.
Regulatory Environment and Future Market Barriers
- Expansion of indications requires additional clinical trials.
- Regulatory approvals depend on biosimilarity demonstrations.
- Reimbursability and payer policies greatly influence accessible pricing.
- Supply chain security policies could affect availability and pricing volatility.
Summary of Key Metrics
| Metric |
Data Point |
| Global immunoglobulin market size |
$20 billion (2022) |
| U.S. HBIG market size |
$0.5 billion (2022) |
| Estimated annual growth rate |
3-4% |
| Typical cost per dose |
$500–$800 |
| Projected price increase per year |
1-2% |
| Biosimilar market entry timeline |
3-5 years |
Key Takeaways
- NDC 00904-7046 (HBIG) has a mature but stable market dominated by few large producers.
- Prices are influenced by manufacturing complexity and supply chain factors.
- Market expansion and biosimilar entry are likely to exert downward pressure on prices over the medium term.
- Regulatory approvals for new indications or biosimilars could significantly alter market dynamics.
- Current pricing closely reflects manufacturing costs, with potential for moderate increases due to inflation and supply constraints.
FAQs
1. Is the product identified by NDC 00904-7046 available globally?
Yes, but availability and regulatory approval vary by country. Major markets include the US, Europe, and select Asian countries.
2. How does biosimilar competition affect the pricing of HBIG?
Biosimilar entry typically results in a 20-30% price reduction, pressuring originator prices over 3-5 years.
3. What are the regulatory hurdles for market expansion of this product?
Additional clinical trials for new indications, demonstration of biosimilarity, and compliance with local regulatory standards are required.
4. How do supply chain issues impact prices?
Plasma shortages or manufacturing delays cause temporary price increases and potential shortages in supply.
5. What are the prospects for new innovations in hepatitis B passive immunization?
Research into monoclonal antibodies and recombinant proteins may offer alternatives, but current pipeline activities are limited.
References
- MarketsandMarkets. (2022). Immunoglobulin market report.
- U.S. Food and Drug Administration. (2022). Approved biologics database.
- Evaluate Pharma. (2022). Biologic drugs market data.
- IQVIA. (2022). National Prescription Data.
- BioWorld. (2022). Biosimilar pipeline reports.
