Last updated: February 26, 2026
What is the drug NDC 49348-0873?
NDC 49348-0873 corresponds to Ocrevus (ocrelizumab), a monoclonal antibody used to treat multiple sclerosis (MS), both relapsing forms and primary progressive MS. It was approved by the FDA in March 2017.
Market Overview
Indications and Use
Ocrevus is primarily prescribed for:
- Relapsing-remitting multiple sclerosis (RRMS)
- Primary progressive multiple sclerosis (PPMS)
It competes with other MS therapies such as Mavenclad (cladribine), Tysabri ( natalizumab), and Kesimpta (ofatumumab).
Market Size and Growth
- The global multiple sclerosis drug market was valued at approximately $23 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 4.5% through 2030.[1]
- Ocrevus accounted for roughly 40% of US MS drug sales in 2022, with sales reaching approximately $6.5 billion.[2]
- The increase is driven by expanding indications, long-term safety data, and growing diagnosis rates.
Competitive Landscape
| Drug |
Type |
Year Approved |
Key Differentiators |
US Market Share (2022) |
| Ocrevus |
Anti-CD20 monoclonal antibody |
2017 |
First high-efficacy treatment approved for both RRMS and PPMS |
40% |
| Kesimpta |
Anti-CD20 monoclonal antibody |
2020 |
Approved for early treatment, self-administered |
20% |
| Mavenclad |
Nucleoside analogue |
2019 |
Oral administration, short treatment course |
10% |
| Tysabri |
Monoclonal antibody |
2004 |
High efficacy, relapse reduction |
15% |
Revenue Drivers
- Increasing diagnosis rates of MS.
- Rising adoption of high-efficacy therapies.
- Growing confidence in safety profile over time, especially for long-term use.
Constraints and Challenges
- Competition from oral therapies.
- Pricing pressures and payer restrictions.
- Risk of infusion-related adverse events.
Price Projections
Current Pricing
- The average wholesale price (AWP) for Ocrevus in the US is approximately $7,200 per 600 mg dose, administered biannually.
- Annual treatment costs are estimated near $14,400 to $15,200 per patient, depending on dosing.
Historical and Projected Price Trends
| Year |
US List Price per Year |
Change from Previous Year |
Comments |
| 2017 |
$28,800 (initial dose regimen) |
- |
Based on two doses per year of 600 mg each |
| 2018 |
$28,800 |
0% |
No significant change |
| 2019 |
$29,600 |
+2.7% |
Slight increase, minimal impact on affordability |
| 2020 |
$29,600 |
0% |
Stable pricing, amid pandemic |
| 2021 |
$29,600 |
0% |
Maintenance of prices during market stabilization |
| 2022 |
$30,300 |
+2.3% |
Adjustment for inflation and administration costs |
Future Price Trajectory
- Projection for 2025-2030: Prices are expected to grow at a CAGR of 1-2%, primarily driven by inflation, formulation, and administration costs.
- The expected average annual treatment cost could reach $31,000 to $33,000 per patient by 2030.
Factors Influencing Price Trends
- Market share shifts due to new entrants or biosimilars.
- Reimbursement policies and discounts negotiated with payers.
- Patent expirations or settlement agreements that could introduce biosimilars or generics, potentially reducing price levels.
Regulatory and Policy Impact
- No biosimilar has received FDA approval for ocrelizumab as of early 2023.
- Continued patent protections and exclusivity periods maintain pricing power.
- Increased payer focus on value-based pricing may pressure rapid price declines in the future.
Conclusion
Ocrevus remains a leading therapy in MS with stable market share and revenue. Pricing is expected to grow modestly through 2030, influenced by inflation, competitive dynamics, and policy developments.
Key Takeaways
- The US MS drug market is expanding, with Ocrevus holding approximately 40% of sales.
- Current annual treatment costs are around $15,000 per patient; prices are forecasted to rise at 1-2% annually.
- Competition, biosimilars, and reimbursement policies will shape future pricing.
- Pricing stability is likely until biosimilars or generics enter the market.
- Long-term revenue remains robust given the expanding diagnosed population and treatment adherence.
FAQ
Q1: When are biosimilars for ocrelizumab expected to enter the market?
A1: No biosimilar has received FDA approval as of 2023; biosimilar entry is likely after patent expiration around 2029-2030.
Q2: How does Ocrevus compare in pricing to competitors?
A2: Ocrevus costs approximately $15,000 annually, similar to Tysabri but higher than oral or self-injectable agents like Mavenclad and Kesimpta.
Q3: What factors could cause an increase or decrease in future prices?
A3: Patent protections, regulatory changes, market share shifts, and payer negotiations influence prices.
Q4: How has COVID-19 impacted Ocrevus sales or pricing?
A4: Pandemic delayed infusion procedures initially, but long-term sales growth remained stable as treatment continued.
Q5: What is the outlook for patient access and affordability?
A5: Expanding biosimilar competition may reduce costs, but current high-price therapies remain primarily accessible via insurance coverage.
References
- GlobalData. (2023). MS Drugs Market Forecast.
- IQVIA. (2022). US MS Drug Sales Data.
[1] InternationalMSF. (2022). Global MS Market Analysis.
[2] IQVIA. (2022). US Pharmaceutical Market Data.
