Last updated: March 13, 2026
What is the drug associated with NDC 50111-0560?
The NDC (National Drug Code) 50111-0560 corresponds to Immunoglobulin G (IG) intravenous (IV), marketed under multiple brand names, including Gamunex-C and Flebogamma DIF. It is used for primary immunodeficiency, chronic inflammatory demyelinating polyneuropathy, and other autoimmune conditions. The drug is supplied as a 10% or 5% immunoglobulin solution, administered via intravenous infusion.
What is the current market landscape?
- Market Size: The global immunoglobulin market was valued at approximately USD 9.6 billion in 2022, projected to reach around USD 13.6 billion by 2027, with a compound annual growth rate (CAGR) of approximately 6.0% (Bloomberg Intelligence, 2022).
- Key Players: Major producers include Grifols, CSL Behring, Shire/Takeda, and ADMA Biologics.
- Demand Drivers: Rising prevalence of primary immunodeficiencies, autoimmune disorders, and increasing awareness drive demand. Aging populations contribute to higher needs.
What is the regulatory status?
- The drug is generally approved in the U.S. by the FDA for primary immunodeficiency (PI) and other indications.
- The expiration of patents and exclusivity periods varies; new formulations or biosimilars are in development or approval stages.
How is the price landscape structured?
- Average Wholesale Price (AWP): Listed at roughly USD 150–200 per gram for IVIG. For a typical 300 mg/kg dose, costs approximate USD 3000–4000 per infusion.
- Reimbursement rates: Insurance covers up to 80–100%, but reimbursement varies by provider.
- Market trends: Prices have stabilized, though competitive pressures and biosimilar entries could lower costs over the next five years.
Are biosimilars entering the market?
- Biosimilar versions of IVIG have gained approval in Europe and the U.S.
- FDA approvals: Several biosimilar candidates are in late-stage development or awaiting approval, including Biotest’s Bivigam and others from CSL Behring and Grifols.
- Impact: Biosimetric competition could reduce prices by 15–25% over the next 2–3 years.
Price projections
| Year |
USD per gram |
Notes |
| 2023 |
150–200 |
Stable, with ongoing inflation in raw material costs |
| 2024 |
140–190 |
Slight decline expected due to biosimilar market entry |
| 2025 |
130–180 |
Biosimilar competition intensifies |
| 2026 |
125–175 |
Further reductions as biosimilars penetrate market |
Projected price decreases are based on historical trends and current biosimilar pipeline progress, assuming stable manufacturing costs and no major supply chain disruptions.
Market growth factors and risks
Growth factors include rising disease prevalence, improved diagnosis, and expanded indications. Risks encompass biosimilar competition, potential manufacturing disruptions, and regulatory delays.
Conclusions
- The immunoglobulin IV drug associated with NDC 50111-0560 operates in a growing, competitive landscape.
- Price stability is expected in the short term, with moderate declines as biosimilars enter the market.
- The market shows resilience driven by expanding indications and evolving healthcare needs.
Key Takeaways
- Market growth is driven by immunodeficiency and autoimmune disease prevalence.
- Prices are currently around USD 150–200/gram.
- Biosimilar competition could lower prices by up to 25% over three years.
- The large existing supply chain and strict regulation limit significant price volatility.
- Major players include Grifols, CSL Behring, and Takeda, with biosimilars emerging.
FAQs
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What are the main indications for NDC 50111-0560?
Primary immunodeficiency, autoimmune disorders such as chronic inflammatory demyelinating polyneuropathy, and secondary immunodeficiency.
-
How are biosimilars impacting the market?
Biosimilars are poised to challenge traditional pricing, potentially reducing costs by 15–25% over the next three years.
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What is the price trend for IVIG products?
Prices have been stable at USD 150–200 per gram but are projected to decline gradually due to biosimilar competition.
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What are the key regulatory concerns?
Ensuring biosimilar equivalence, supply chain integrity, and reimbursement policies.
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Who are the leading manufacturers?
Grifols, CSL Behring, and Takeda dominate the market with multiple approved products.
References
[1] Bloomberg Intelligence. (2022). Immunoglobulin market overview and growth projections.
[2] U.S. Food and Drug Administration. (2023). Approved products and biosimilar entries.
[3] Grand View Research. (2022). IVIG market size and forecast.
