Last updated: February 22, 2026
Overview of NDC 78206-0121
NDC 78206-0121 is a drug product identified as Ocrevus (Ocrelizumab), a monoclonal antibody approved for the treatment of multiple sclerosis (MS). It was first approved by the FDA in March 2017 for relapsing forms of MS and primary progressive MS. Ocrevus is administered via intravenous infusion.
Market Size and Demand Drivers
Epidemiology of Multiple Sclerosis
- Global prevalence: Estimated at 2.8 million in 2020, with the U.S. accounting for approximately 950,000 cases (Multiple Sclerosis International Federation [MSIF], 2020).
- U.S. prevalence: Around 1 million, with an annual incidence of approximately 20,000 new cases, primarily diagnosed in adults aged 20-50.
- Treatment trends: Growing adoption of disease-modifying therapies (DMTs), increasing awareness, and earlier diagnosis expand the market.
Competitive Landscape
- Major competitors: AstraZeneca’s Kesimpta (Ofatumumab), Biogen’s Tysabri (Natalizumab), Novartis’s Gileyna (Siponimod), and others like Teva’s Aubagio (Teriflunomide).
- Market share shifts: Ocrevus holds approximately 40% of the DMT market for MS in the U.S., with biologics dominating the segment.
- Market expansion: Potential growth in primary progressive MS due to expanded indications.
Revenue Estimates
- Current sales (2022): ~$4.2 billion globally, with U.S. sales accounting for ~$3.2 billion.
- Growth rate: Compound annual growth rate (CAGR) projected at 9-11% over the next five years, driven by new patients, expanding indications, and continued market penetration.
Price Analysis
Current Pricing
- List price per vial: Approx. $7,000–$8,000 (Source: Medicaid Drug Claim Data, 2022).
- Dosing schedule: 300 mg administered as two 150 mg infusions initially, then maintenance dosing at 600 mg every six months.
- Average annual treatment cost: Estimated at $80,000–$85,000 per patient, considering infusion costs and auxiliary services.
Price Trends
- The price per vial has remained relatively stable since initial launch, with slight increases annually due to inflation and pharmacy markups.
- Reimbursement: Most payers negotiate discounts; the net price often below list price.
Future Price Projections
- Price stabilization: Expected due to the biosimilar landscape mature and biosimilars for other MS biologics entering gaps.
- Potential price increases: Marginal, around 2-3% annually, aligned with inflation.
- Biosimilar impact: Entry of biosimilars could reduce list prices by 20–30% over the next 3-5 years, increasing access and patient uptake.
Regulatory and Policy Context
- Patent protection: Patents extend until at least 2028; biosimilar development is ongoing.
- Pricing regulations: US CMS and private payers scrutinize price increases, potentially limiting rapid upward movement.
- Reimbursement: Medicare, Medicaid, and private insurers widely cover Ocrevus with varying co-pays and discounts.
Market Risks and Opportunities
Risks
- Biosimilar competition: Entry could erode market share and pressure prices.
- Regulatory delays or restrictions: Stringent policies could limit market growth.
- Pricing pressure: Payers demanding discounts or formulary restrictions.
Opportunities
- New indications: Approval for additional MS subtypes or other autoimmune diseases.
- Market expansion: Increasing use among primary progressive MS patients.
- Combination therapies: Potential for off-label combination use.
Summary
| Metric |
Data |
| Current global sales |
~$4.2 billion (2022) |
| U.S. sales |
~$3.2 billion |
| Estimated patient cost |
~$80,000–$85,000 annually |
| Price per vial |
~$7,000–$8,000 |
| Market CAGR (2023–2028) |
9–11% |
| Biosimilar impact |
20–30% price reduction over 3–5 years |
Key Takeaways
- The MS biologic market remains robust, with Ocrevus capturing a significant share.
- Pricing remains stable but faces downward pressure from biosimilars.
- Future growth hinges on expanding indications and market penetration.
- Regulatory and reimbursement policies influence pricing dynamics.
- Price projections suggest marginal increases, with biosimilar competition likely to moderate costs eventually.
FAQs
1. What factors influence Ocrevus pricing?
Reimbursement negotiations, biosimilar entry, and inflation drive the stability or modest increases in prices.
2. How will biosimilars affect Ocrevus’s market?
Biosimilars are expected to reduce list prices by 20–30%, potentially capturing 30–50% of the market within five years.
3. Are there plans for new indications for Ocrevus?
Yes, ongoing clinical trials explore uses in other autoimmune diseases, potentially expanding the market.
4. How does the U.S. pricing compare with other markets?
U.S. prices are higher, driven by less regulation and more payer negotiations, versus controlled prices in Europe.
5. What is the outlook for further price increases?
Limited, constrained by payer pressure and biosimilar competition, with projections at 2-3% annually.
References
- Multiple Sclerosis International Federation (MSIF). (2020). Atlas of MS. Available at: https://worldmsdatabase.org
- IQVIA. (2022). Global Medicine Data.
- CMS. (2022). Medicare Part B Drug Payment Policy.
- EvaluatePharma. (2022). Pharmaceutical Market Intelligence.
- U.S. FDA. (2017). Ocrevus (Ocrelizumab) Approval Announcement.
