Last updated: February 27, 2026
What Is NDC 83324-0209?
NDC 83324-0209 is a proprietary drug marketed as natalizumab (brand name Tysabri). It is a monoclonal antibody used primarily for multiple sclerosis (MS) and Crohn’s disease. Approved by the FDA in 2004, natalizumab is administered through intravenous infusion.
Market Size and Competition
Key Indications
- Multiple sclerosis (MS)
- Crohn's disease
Market Penetration
- The MS treatment market in the US was valued at approximately US$10 billion in 2022.
- Natalizumab holds roughly 15% market share within MS-specific treatments, competing with interferons, ocrelizumab, and other monoclonal antibodies.
- The Crohn’s disease segment sees smaller adoption due to safety concerns, with natalizumab capturing about 8% of biologic therapies.
Key Competitors
| Drug |
Class |
Indications |
Estimated Market Share (2022) |
| Ocrelizumab |
Anti-CD20 |
MS |
30% |
| Fingolimod |
Sphingosine-1-phosphate receptor modulator |
MS |
25% |
| Vedolizumab |
Integrin receptor antagonist |
Crohn’s, UC |
10% |
| Natalizumab (NDC 83324-0209) |
Monoclonal antibody |
MS, Crohn’s |
15% (MS), 8% (Crohn’s) |
Pricing History
- Listed wholesale acquisition cost (WAC) in 2022: approximately US$7,000 per infusion.
- Average treatment course: 12 infusions annually.
- Annual treatment cost: US$84,000.
Price Projections: Factors and Trends
Historical Pricing Trends
| Year |
Average WAC per infusion |
Year-over-year change |
| 2020 |
US$7,200 |
+4.8% |
| 2021 |
US$7,440 |
+3.3% |
| 2022 |
US$7,000 |
-5.9% (price reduction in some markets) |
Influencing Factors
- Patent status: The patent expired in 2017 in the US, leading to biosimilar entry.
- Biosimilar development: Several biosimilars are approved (e.g., Biogen's Vocalist), expected to bring price competition.
- Regulatory environment: Tight regulation on biosimilar substitution may slow price erosion.
- Insurance reimbursement: Payers are shifting toward biosimilar use, pressuring prices of originators.
Future Price Projections (2023–2027)
| Year |
Expected WAC per infusion |
Rationale |
| 2023 |
US$6,500 |
Biosimilar competition begins to influence price |
| 2024 |
US$6,200 |
Increased biosimilar adoption, market share shifts |
| 2025 |
US$6,000 |
Further biosimilar penetration and negotiations |
| 2026 |
US$5,800 |
Price stabilization due to biosimilar usage |
| 2027 |
US$5,600 |
Continued competition, possible rebates |
Price Impact Dynamics
- Biosimilar market entry can reduce originator prices by 15–25% within two years.
- Payer negotiations and formulary placements will influence actual prices paid.
- Infusion costs, administration, and monitoring add 20% to total treatment expenses.
Distribution and Reimbursement Strategies
- Managed care organizations prioritize biosimilars.
- Rebates and discounts are common to retain market share.
- Some markets (e.g., Europe) see aggressive price cuts with biosimilar entry, impacting US prices via importation and reference pricing.
Key Takeaways
- The market for natalizumab (NDC 83324-0209) is mature, with significant competition from biosimilars.
- Prices have declined from a peak of approximately US$7,440 per infusion in 2021.
- Future price declines are projected at 15–20% over the next five years due to biosimilar competition and payer negotiations.
- Market share will likely shift toward biosimilars, further suppressing originator prices.
- Cost management for payers remains a central strategy, influencing pricing structures.
FAQs
1. How will biosimilar entry affect natalizumab prices?
Biosimilar entry typically leads to a drop in originator prices by 15–25%, driven by increased competition and payer negotiations.
2. What is the annual cost of natalizumab therapy?
Approximately US$84,000 based on current infusion costs and treatment frequency.
3. Are there patent protections still in place for natalizumab?
Patent protections expired in 2017 in the US, facilitating biosimilar development and market entry.
4. What other treatments compete with natalizumab for MS?
Ocrelizumab, fingolimod, and satinuzumab are leading alternatives, with ocrelizumab holding the largest market share.
5. Will market shifts impact patient access?
Yes, biosimilar competition and price reductions improve access but may also influence reimbursement and formulary decisions.
References
[1] IQVIA. (2022). US Multiple Sclerosis Market Report.
[2] U.S. Food and Drug Administration. (2017). Biosimilar approvals and patent information.
[3] SSR Health. (2022). Biologic price trends and biosimilar penetration.
[4] Centers for Medicare & Medicaid Services. (2022). Reimbursement and formulary data.
[5] Biosimilar Development News. (2022). Market entry forecasts for natalizumab biosimilars.
