Last updated: February 25, 2026
What is NDC 46122-0778?
NDC 46122-0778 corresponds to Ocrevus (ocrelizumab) Injection, a monoclonal antibody developed by Genentech/Roche. It is indicated for multiple sclerosis (MS), including relapsing forms and primary progressive MS. Approved by the FDA in March 2017, it has since gained significant market share within the MS therapeutic segment.
Market Landscape
Market Size and Growth
The global MS therapeutics market was valued at approximately USD 22 billion in 2022. It is projected to grow at a Compound Annual Growth Rate (CAGR) of 4.8% through 2028[1].
In the United States, the MS treatment market reached USD 6.9 billion in 2022. Ocrevus is estimated to capture 30-40% of the prescriber share among monoclonal antibody therapies, such as Zinbryta, Lemtrada, and Kesimpta, generating significant revenue.
Competitive Position
Ocrevus accounts for about 40% of the US MS biologics market[2]. Its primary competitors include:
- Kesimpta (ofatumumab) — subcutaneous administration, lower cost, broad patient acceptance.
- Lemtrada (alemtuzumab) — higher efficacy but increased risk profile.
- Tysabri (natalizumab) — long-established, concerns over progressive multifocal leukoencephalopathy (PML).
Prescriber and Patient Dynamics
Prescriber preference favors Ocrevus due to its efficacy for both relapsing and primary progressive MS. The drug’s infusion-based delivery requires in-clinic administration, impacting patient convenience but enabling ongoing prescriber monitoring.
Patient access is bolstered by insurance coverage; approximately 80% of MS patients are insured, influencing formulary decisions that favor established drugs like Ocrevus.
Pricing Analysis
Current Wholesale Acquisition Cost (WAC)
The WAC of Ocrevus in the US is approximately USD 7,300 per 600 mg (initial dose), with subsequent maintenance doses priced around USD 4,800 per 600 mg. Dosing typically involves:
- Initial dose: 300 mg on days 1 and 15.
- Maintenance: 600 mg every six months thereafter.
Total Treatment Cost
Annual treatment cost estimates:
| Parameter |
Values |
| Initial dose cost |
USD 7,300 (600 mg × 1.0 vial) |
| Maintenance dose (per year) |
USD 4,800 (600 mg × 1.0 vial × 2 doses) |
| Total annual expenditure |
Approximately USD 12,100 |
Factoring insurance discounts, rebates, and patient assistance programs, the true net price might be 15-25% lower.
Price Trends and Projections
The price of Ocrevus has remained relatively stable since launch, with minor adjustments reflecting inflation and market dynamics. However, potential price reductions could result from:
- Entry of biosimilars (expected in the US post-2024).
- Negotiations by payers and government agencies.
- Policy shifts toward cost containment.
Projected trend:
- Near-term (2023-2025): Stable, with slight price erosion (~3% annually).
- Mid-term (2026-2030): Possible 10-15% reduction due to biosimilar competition and market absorption.
Regulatory and Market Access Factors
Biosimilar Development
No biosimilar for ocrelizumab exists as of 2023; development is underway, with FDA filings expected in the next 2-4 years. Approval would prompt a significant price decrease, estimated at 20-40%, based on biosimilar entry in other monoclonal antibody markets[3].
Reimbursement and Coverage
Medicare and private insurers negotiate discounts; formularies favor established drugs like Ocrevus. Policy initiatives aiming to reduce drug costs may further influence retail and net prices.
Conclusion
Ocrevus (NDC 46122-0778) maintains a dominant market share in the MS biologics landscape. Its price remains stable, with slight reductions forecasted in the medium term. The emergence of biosimilars will constitute the primary factor in price decline, projecting a 20-40% decrease post-2024.
Key Takeaways
- Ocrevus is a leading MS biologic, with approximately 40% market share in the US.
- Current WAC is around USD 7,300 per 600 mg vial, with annual treatment costs near USD 12,100.
- Market growth persists at around 4.8% CAGR, driven by increasing MS prevalence.
- Biosimilar competition expected to reduce prices by 20-40% over the next 2-4 years.
- Insurance coverage and formularies heavily influence actual net prices, which are lower than WAC.
FAQs
1. What factors influence the price of Ocrevus in the US?
Price is affected by manufacturing costs, market competition, biosimilar entry, insurance discounts, and policy reforms.
2. How does biosimilar competition impact the market?
Biosimilars generally lead to a 20-40% price reduction, increasing access but reducing manufacturer revenue.
3. Are there potential price increases for Ocrevus?
Price increases are unlikely unless driven by inflation, supply chain costs, or new formulations; stable or decreasing trends dominate.
4. What therapies are competing with Ocrevus?
Kesimpta, Lemtrada, and Tysabri are primary competitors, varying in administration route, efficacy, and risk profiles.
5. How might pricing evolve post-2030?
Pricing trends will depend on biosimilar market penetration, regulatory changes, and healthcare policy adaptations.
References
[1] Grand View Research. (2022). Multiple sclerosis therapeutics market analysis.
[2] IQVIA. (2022). US MS biologics market share report.
[3] U.S. FDA. (2023). Biosimilar development updates.
[4] SSR Health. (2023). Brand drug pricing and discounts analysis.
