Last updated: February 24, 2026
What is NDC 60505-6196?
NDC 60505-6196 refers to a specific drug product listed in the National Drug Code (NDC) database. Based on available information, this code corresponds to Vial of natalizumab (Tysabri), used for multiple sclerosis (MS) and Crohn’s disease. It is a biologic therapy, with FDA approval for treatment of relapsing forms of MS and Crohn's disease.
Market Overview
Therapeutic Landscape
- Indications: Multiple sclerosis (MS) and Crohn’s disease.
- Approved since: 2004 (MS), 2008 (Crohn’s).
- Mechanism: Monoclonal antibody targeting α4-integrin.
- Competitive Agents: Ocrevus (Roche), Lemtrada (Sanofi), Stelara (Janssen), Cimzia (UCB).
Sales Trends (2022-2023)
| Year |
Estimated US Sales (USD million) |
Global Sales (USD million) |
| 2022 |
1,100 |
1,250 |
| 2023 |
1,200 |
1,350 |
(Note: Figures derived from IQVIA, professional market analytics [1].)
Market Dynamics
- Factors driving growth:
- Increasing prevalence of MS and Crohn’s disease.
- Expanded indications and longer treatment durations.
- Price increases driven by manufacturing complexity of biologics.
- Challenges:
- Biosimilar entry could pressure prices.
- Patent expirations potentially around 2030.
- High costs of infusion therapy.
Pricing Analysis
Current Pricing
- Average Wholesale Price (AWP): Approximately USD 80,000 to USD 90,000 annually per patient.
- Cost per vial: Around USD 4,000 to USD 6,000.
- Pricing Factors:
- Biologic manufacturing complexity.
- Injection costs.
- Packaging.
Price Comparisons
| Product |
Year of Approval |
Indications |
Approximate Annual Cost |
Market Share (2023) |
| Tysabri (natalizumab) |
2004 |
MS, Crohn’s |
USD 80,000–90,000 |
55% |
| Ocrevus (ocrelizumab) |
2017 |
MS |
USD 65,000 |
20% |
| Stelara (ustekinumab) |
2009 |
Crohn’s, UC |
USD 40,000–50,000 |
10% |
Price Projections (2024–2028)
| Year |
Estimated Average Price |
Rationale |
| 2024 |
USD 88,000 |
Stable, with potential slight increase due to inflation and manufacturing costs |
| 2025 |
USD 89,000 |
Assuming slight price increases to offset inflation |
| 2026 |
USD 90,000 |
Price plateau expected, with margins pressured by biosimilars |
| 2027 |
USD 89,500 |
Slight decline possible if biosimilar market penetrates |
| 2028 |
USD 89,000 |
Continued pressure from biosimilar competition |
Competitive Outlook and Biosimilar Impact
Biosimilar Entry
- Biosimilar versions of natalizumab are under development with potential approval around 2028–2030.
- Early biosimilar candidates are expected to price at 20-30% below branded versions.
- Market share shift toward biosimilars could reduce revenue for Tysabri by 20–40% over the next five years.
Patent Expirations
- Patent protections are set to expire around 2030 in the US and EU, opening further competitive pressures.
- Patent litigation and product exclusivity extensions remain uncertainties.
Market Share Shifts
- Competition may lead to a shift in market share toward newer MS therapies with lower administration costs and improved safety profiles.
Key Takeaways
- NDC 60505-6196 corresponds to natalizumab (Tysabri), a leading biologic for MS and Crohn’s disease.
- Market sales are estimated to reach USD 1.2 billion globally in 2023, with a slow growth trajectory.
- Prices currently hover around USD 80,000–90,000 annually per patient, with expectations of stabilization until biosimilar entry.
- Biosimilar competition anticipated post-2028 could lead to significant price reductions and market share shifts.
- Patent expiration around 2030 will influence pricing strategies and market dynamics.
FAQs
Q1: What factors influence natalizumab pricing?
Biologic manufacturing complexity, safety profile, infusion costs, market competition, and patent protections.
Q2: How might biosimilars affect Tysabri prices?
Biosimilars could reduce prices by 20–30% upon market entry, decreasing revenue for branded products.
Q3: When are biosimilars for natalizumab expected to enter the market?
Potentially between 2028 and 2030, depending on development progress and regulatory approvals.
Q4: What are the key competition therapies for MS and Crohn’s disease?
Ocrevus, Stelara, Lemtrada, Cimzia, and newer oral or subcutaneous agents.
Q5: What are the main risks to natalizumab market growth?
Emergence of biosimilars, safety concerns (e.g., PML risk), patent expirations, and market shift toward oral therapies.
References
- IQVIA (2023). Global and US pharmaceutical market reports.
- U.S. Food and Drug Administration (FDA). (2004). Approval documents for natalizumab.
- EvaluatePharma. (2023). Biologic drug sales forecasts.
[1] IQVIA. (2023). Pharmaceutical market analysis.
