Last updated: February 16, 2026
What is NDC 75834-0326?
NDC 75834-0326 corresponds to Ocrevus (ocrelizumab), a monoclonal antibody developed by Genentech (a Roche subsidiary). It is approved by the FDA for multiple sclerosis (MS) and primary progressive MS (PPMS).
Market Overview
Indications and Approval Timeline
- Multiple Sclerosis (MS): Approved by the FDA in 2017.
- Primary Progressive MS (PPMS): Approved in 2019.
Market Size
- Prevalence: Estimated at 2.8 million globally, with approximately 1 million in the U.S. (source: National Multiple Sclerosis Society).
- US Market: The MS market in the U.S. was valued at roughly $6 billion in 2022.
- Ocrevus's Market Share: Estimated to account for approximately 45-50% of MS biologic treatments in 2022, driven by efficacy and dosing schedule.
Competitors
- Siponimod (Mayzent)
- Natalizumab (Tysabri)
- Alemtuzumab (Lemtrada)
- Ofatumumab (Kesimpta)
- Other emerging agents targeting MS pathways.
Pricing History and Strategy
Current Pricing
- The wholesale acquisition cost (WAC) for Ocrevus is approximately $7,800 per 300 mg vial.
- Typical dosing schedule:
- Year 1: 600 mg every 6 months (two 300 mg infusions)
- Later doses: 600 mg every 6 months.
- Annual Cost: About $31,200 for a patient on standard therapy, based on dosage.
Pricing Trends
- Ocrevus pricing has remained relatively stable since approval, with small adjustments for inflation or package changes.
- Discounts and rebates vary between payers but generally reduce the net price.
Market-Pricing Compared to Competitors
- Tysabri: ~$8,500 per infusion (~$17,000 annually).
- Lemtrada: ~$120,000 initially, then ~$61,000 annually.
- Kesimpta: ~$7,600 per month (~$91,200 annually).
Ocrevus's pricing reflects its dosing frequency and therapeutic niche.
Price Projection and Market Dynamics
Forecast Assumptions
- Market share stabilizes at around 45-50% within 5 years.
- Annual treatment costs remain within 5% of current levels.
- Increased adoption in PPMS expands total addressed market from 15% to 25%.
- Biosimilar entry: No immediate biosimilars anticipated within 3–5 years, given patent protections and current market exclusivity.
| Projected Price Trends (Next 5 Years) |
Year |
Estimated Price per Year |
Rationale |
| 2023 |
$31,200 |
Base price, stable due to established pricing strategies. |
| 2024 |
$32,760 |
Slight increase for inflation and administrative costs. |
| 2025 |
$34,400 |
Market stabilization; minimal price competition. |
| 2026 |
$36,120 |
Potential marginal increase; payer negotiations limit hikes. |
| 2027 |
$37,830 |
Possible volume-driven discounts but overall stable pricing. |
Key Drivers for Price Stability:
- High efficacy and evolving label expanding treated populations.
- Limited biosimilar competition due to patent protections extending until at least 2030.
- Payer negotiations favor maintained pricing due to treatment benefits.
Market Challenges and Risks
- Emerging Therapies: Development of oral agents or more potent biologics may threaten market share.
- Regulatory Changes: Patent litigation or regulatory speedups for biosimilars could impact pricing strategies sooner than expected.
- Market Saturation: Increased penetration in early MS treatment stages might limit growth but stabilize revenue streams.
Strategic Implications for Stakeholders
- Pharmaceutical Companies: Price maintenance can be expected for the next 3–5 years, with strategic engagement on payor contracts.
- Investors: Stability in revenue streams supported by patent life and efficacy profile suggests moderate valuation.
- Payers: Continued negotiation for discounts and value-based arrangements are critical to manage costs.
Conclusion
Ocrevus (NDC 75834-0326) maintains a stable market position with current pricing around $31,200 annually. Limited near-term biosimilar competition and high efficacy justify price stability. Projections indicate slight increases through 2027, contingent on market dynamics, payer negotiations, and therapeutic developments.
Key Takeaways
- Ocrevus remains a leading MS biologic, with stable pricing predicted for the next five years.
- The U.S. MS market is growing, but competition and biosimilar entries could influence future pricing.
- Estimated annual treatment costs are projected to increase marginally, reaching ~ $38,000 by 2027.
- Patent protections delay biosimilar entry until 2025–2030, supporting current price stability.
- Strategic pricing and market expansion in PPMS will influence revenue streams.
FAQs
1. What factors influence Ocrevus's pricing in the U.S.?
Pricing is driven by manufacturing costs, therapeutic value, payer negotiations, patent protections, and market competition.
2. When are biosimilars for Ocrevus expected?
Exact timelines are uncertain, but biosimilar entry is likely between 2025 and 2030 due to patent exclusivity.
3. How does Ocrevus compare economically to competitors?
Its annual cost (~$31,200) is comparable to or slightly lower than other biologics like Tysabri but higher than some oral agents, reflecting its dosing schedule and efficacy.
4. What are the main market risks for Ocrevus?
Biosimilar competition, emerging oral therapies, and regulatory changes could impact its market share and pricing.
5. How might market expansion in PPMS affect revenue?
Expanded indications could increase patient numbers, boosting revenue without significant price reductions, provided payers support the expanded label.
References
- National Multiple Sclerosis Society. (2022). MS Prevalence Data.
- Medicare & Medicaid Pricing Data. (2022). Ocrevus Wholesale Pricing.
- FDA Approval Documents. (2017, 2019). Ocrevus Indications.
- IQVIA. (2022). MS Market Analysis.
- Pharma Intelligence. (2023). Biologic Drug Patent Lifespans and Biosimilar Outlooks.
