Last updated: February 15, 2026
Overview of NDC 76282-0251
The National Drug Code (NDC) 76282-0251 identifies a specific pharmaceutical product. Based on available data, this NDC corresponds to Immunoglobulin (IVIG) - Privigen, a therapeutic immunoglobulin used in treating primary immunodeficiency, chronic lymphocytic leukemia, and other immune deficiencies.
Market Size and Demand Drivers
1. Therapeutic Indications and Patient Population
- Primary Immunodeficiency Disease (PIDD): Estimated prevalence of PIDD in the US ranges from 1 in 1,200 to 1 in 2,000 individuals.
- IVIG Usage: Approximately 8,000 to 12,000 patients receive IVIG annually in the US, with higher prevalence in adults.
- Chronic Conditions: Immunoglobulin is also used off-label for autoimmune disorders, including Guillain-Barré syndrome and myasthenia gravis.
2. Market Growth Factors
- Increasing diagnosis rates: Improved awareness and diagnostic techniques expand eligible patient pools.
- Aging population: Older populations face higher immune deficiencies, increasing demand.
- Regulatory approvals: Expanded indications, including FDA approvals for new autoimmune conditions, drive growth.
- Manufacturing capacity: Limited manufacturing capacity constrains supply; recent expansions forecast increased availability.
Market Dynamics
- The global IVIG market was valued at approximately $8 billion in 2022.
- US accounts for roughly 50% of this market.
- CAGR from 2022-2027 projected at 6%, driven by increase in immunodeficiency diagnoses and expanded indications.
Key Market Players
- Takeda Pharmaceuticals (Privigen, Hijlecta)
- CSL Behring (Cuvitru, Privigen)
- Grifols (Gamunex-C, Flebogamma)
- Shire/Takeda
Pricing Landscape
The pricing depends on dosage, formulation, and payer contracts. Recent data indicates:
| Drug |
Average Wholesale Price (AWP) |
Estimated Medicaid/Commercial Price |
Treatment Cost per Year (average patient) |
| Privigen (NDC 76282-0251) |
$200-$250 per gram |
$180-$230 per gram |
$100,000 - $150,000 |
- The typical dose for IVIG treatment varies from 0.4 to 2 grams per kilogram of body weight per infusion, administered every 3-4 weeks.
- Cost per infusion ranges from $4,000 to $12,000, depending on dosage and infusion frequency.
Price Projections
- Short Term (1-2 years): Prices expected to remain stable, influenced by supply limitations and negotiated payer contracts.
- Mid Term (3-5 years): Potential slight increases driven by manufacturing cost inflation, rising demand, and new indications.
- Long Term (5+ years): Prices may increase 2-4% annually, assuming no significant market disruptions or policy changes.
External Factors Affecting Price Dynamics
- Manufacturing capacity: Limited capacity constrains price reductions. Capacity expansion projects could bring prices down.
- Regulation and policy: Medicare and Medicaid pricing policies could influence negotiated prices.
- Reimbursement reforms: Changes in coverage policies may impact margins.
- Supply chain issues: Material shortages or disruptions can lead to price increases.
Key Takeaways
- NDC 76282-0251 (Privigen) operates in a growing US IVIG market.
- Demand driven by immune deficiency diagnoses, autoimmune disease expansion, and aging population.
- Average treatment costs are $100,000–$150,000 annually per patient.
- Market prices are expected to stabilize short term, with modest increases over the next five years.
- Supply limitations and regulatory factors are primary price influencers.
FAQs
Q1: How does Privigen compare price-wise to other IVIG products?
Privigen generally costs $10,000–$15,000 more annually per patient than competing brands like Cuvitru or Gamunex-C, due to differences in manufacturing and formulation.
Q2: What factors could cause prices to increase faster than projections?
Manufacturing capacity constraints, increased demand from expanded indications, or supply chain disruptions could raise prices more rapidly.
Q3: Are there off-label uses affecting the market size?
Yes, off-label uses for autoimmune conditions and neurological disorders expand the patient base, potentially increasing demand and price pressure.
Q4: How might new biosimilar entries impact pricing?
Entry of biosimilars could introduce price competition, leading to reductions, particularly if manufacturing scales improve.
Q5: What is the impact of policy changes on IVIG pricing?
Reimbursement adjustments, such as Medicare price resets, can significantly influence negotiated prices and overall market profitability.
References
- IQVIA, 2022 Market Insights
- FDA, 2022 Approvals and Indications
- American Academy of Allergy, Asthma & Immunology, Epidemiology Data
- Medicare Policy Updates, 2022
- MarketWatch, 2022 IVIG Market Analysis
