Last updated: March 6, 2026
What is NDC 69367-0326?
NDC 69367-0326 refers to a specific pharmaceutical product. Based on available data, this code corresponds to Ocrevus (ocrelizumab), a monoclonal antibody used in the treatment of multiple sclerosis (MS), including relapsing forms and primary progressive MS. Ocrevus was approved by the FDA in March 2017 and by the European Medicines Agency (EMA) shortly afterward.
Market Landscape
Market Size
The multiple sclerosis treatment market globally is valued at approximately USD 28 billion in 2022 and is projected to reach USD 40 billion by 2027, growing at a CAGR (compound annual growth rate) of around 7.5%. Ocrevus holds a significant share, estimated at 35–40% of the MS biologics segment.
Competition
Major competitors for Ocrevus include:
- Tysabri (natalizumab) – Biogen
- Kesimpta (ofatumumab) – Novartis
- Rebif (interferon beta-1a) – Ipsen/Biogen
- Avonex (interferon beta-1a) – Biogen
Market positioning depends on efficacy, safety profiles, and dosing convenience. Ocrevus is administered biannually, providing a logistical advantage.
Key Market Drivers
- Increasing MS prevalence, especially in North America and Europe.
- Aging populations and improved diagnosis rates.
- Preference for biologics with oral or less frequent infusion schedules.
Regulatory and Patent Landscape
- Patent expiration is projected around 2028–2030.
- Biosimilar development is ongoing; biosimilar launches could impact pricing and market share.
Price Dynamics and Cost Analysis
Current Pricing
- U.S. retail price: Approximately USD 85,000 per year for the standard dosing schedule.
- European prices: Ranges from EUR 55,000 to EUR 70,000 annually, depending on country and reimbursement policies.
- Insurance coverage: Significantly influences patient costs; payers negotiate discounts and rebates.
Cost Breakdown
- Drug manufacturing accounts for roughly 25% of the list price.
- Distribution, administration, and monitoring add approximately 15–20%.
- Payer rebates and discounts can reduce the net price by 15–30%.
Historical Price Trends
Since approval, Ocrevus prices have remained relatively stable, with minor adjustments reflecting inflation and competitive pressures. No substantial discounts have been publicly documented in the U.S., but contracts with payers often involve considerable rebates.
Future Price Projections
Factors Influencing Price Trends
- Potential entry of biosimilars, projected around 2028, could reduce prices by 30–50% or more.
- Increased market competition from products like Kesimpta and generic alternatives.
- Regulatory changes encouraging price transparency and negotiation.
- Expansion into emerging markets with different pricing sensitivities.
Projected Price Ranges (2023–2030)
| Year |
Estimated Price Range (USD/year) |
Notes |
| 2023 |
USD 85,000 – USD 90,000 |
Current market price |
| 2025 |
USD 80,000 – USD 85,000 |
Slight decrease expected due to competition and negotiations |
| 2028 |
USD 65,000 – USD 75,000 |
Biosimilar entry may trigger significant discounts |
| 2030 |
USD 50,000 – USD 65,000 |
Biosimilar dominance, patent expiry |
Impact of Biosimilars
Biosimilars could enter the market starting 2028. Price reductions could be substantial, especially in markets where biosimilar adoption is high. Historically, biosimilar entry leads to a 30–50% drop in price within 2–3 years.
Key Considerations for Stakeholders
- Manufacturers should strategize patent defenses until 2028.
- Payers and providers should prepare for price erosion starting mid-decade.
- Investors should monitor biosimilar pipeline progress for valuation adjustments.
Key Takeaways
- NDC 69367-0326 is Ocrevus, a leading MS biologic with a market share around 35–40%.
- Current U.S. list price: approximately USD 85,000 annually.
- Market growth driven by increasing MS prevalence and favorable dosing schedule.
- Biosimilar competition expected from 2028, likely reducing prices by up to 50% within a few years.
- Price stability is forecasted until biosimilar entry, after which significant reductions are probable.
FAQs
1. When will biosimilars for Ocrevus become available?
Biosimilars are projected to launch around 2028, based on patent expirations.
2. How does Ocrevus compare to competitors in efficacy?
Ocrevus has demonstrated superior efficacy in reducing relapses and slowing disability progression compared to some older biologics, with a favorable safety profile.
3. What are the main factors affecting U.S. pricing negotiations?
Payer negotiations, rebate agreements, and formulary placements influence the net price paid by insurers.
4. How might regulatory changes influence future pricing?
Regulations promoting price transparency and encouraging biosimilar adoption could lead to increased discounts.
5. What markets could see lower prices earlier?
Emerging markets with lower healthcare expenditure levels may adopt biosimilars sooner, leading to reduced prices in those regions by 2028–2030.
References
[1] Market research data, GlobalData (2022). "Multiple Sclerosis Therapeutics Market Analysis."
[2] FDA Approval Documents for Ocrevus, 2017.
[3] IQVIA. "U.S. Pharma Market Data," 2022.
[4] Biosimilar Market Forecast, EvaluatePharma, 2022.
[5] European Medicines Agency. "Ocrevus Summary of Product Characteristics," 2017.
