Last updated: February 23, 2026
What is NDC 75834-0205?
NDC 75834-0205 corresponds to Ocrevus (ocrelizumab), a monoclonal antibody approved by the FDA for multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS). It was initially approved in March 2017 and marketed by Genentech, a member of Roche.
Market Size and Demand Drivers
Disease Prevalence
- Multiple sclerosis affects approximately 2.8 million people globally.
- In the U.S., prevalence estimates range between 250,000 and 350,000 individuals with MS.
- PPMS accounts for around 10-15% of all MS cases.
Growth Factors
- Rising diagnosis rates due to improved detection.
- Evolving treatment guidelines favoring high-efficacy therapies.
- Increasing approval for expanded indications, including primary progressive MS.
Competitive Landscape
| Drug |
Mechanism |
Approved Indications |
Market Share (2022) |
Key Competitors |
| Ocrevus (ocrelizumab) |
CD20+ B cell depletion |
RMS (relapsing MS), PPMS |
70-75% |
Lemtrada, Tysabri, Mavenclad |
| Lemtrada (alemtuzumab) |
Monoclonal antibody |
RMS, secondary progressive MS |
15-20% |
Ocrevus, Tysabri |
| Tysabri (natalizumab) |
Integrin inhibitor |
RMS, PPMS (off-label) |
10% |
Ocrevus |
Market Opportunity
The U.S. MS therapeutics market was valued at approximately $4.2 billion in 2022, with projections reaching around $7 billion by 2030, driven by the factors above and increased adoption of high-efficacy DMTs like Ocrevus.
Price History and Current Pricing Strategies
Wholesale Acquisition Cost (WAC)
- Initial launch price (2017): Approx. $65,000 per year per patient.
- Adjustments: Prices have seen minor reductions or stabilization post-initial launch; current WAC remains around $63,000-$65,000 annually per patient.
Pricing Trends
| Year |
Approximate Price |
Annual Percentage Change |
| 2017 |
$65,000 |
— |
| 2018 |
$64,500 |
-0.8% |
| 2019 |
$63,750 |
-1.2% |
| 2020 |
$63,000 |
-1.2% |
| 2021 |
$63,000 |
0% |
| 2022 |
$63,000 |
0% |
Reimbursement and Pricing Dynamics
Reimbursements for Ocrevus depend on negotiations between Roche, payers, and healthcare providers. Rebates, discounts, and patient assistance programs influence net prices in practice.
Comparison with Competitors
- Lemtrada’s annual cost is approximately $73,000.
- Tysabri’s annual WAC is roughly $78,000.
Ocrevus remains competitive due to its balanced efficacy-cost profile.
Future Price Projections
Factors Influencing Pricing
- Price regulation and pricing transparency initiatives.
- The introduction of biosimilars or generics (not currently in the U.S. market).
- Market competition and biosimilar developments in other regions.
Projection Model
| Year |
Expected WAC |
Factors |
Notes |
| 2023 |
$63,000 |
Stable |
No major price adjustments |
| 2024 |
$62,500 |
Slight decrease |
Market pressure for lower prices |
| 2025 |
$62,000 |
Cost pressures |
Potential impact of biosimilars in Asia or Europe. |
Risks
- Price regulation initiatives may cap future increases.
- New competitors or biosimilars could exert downward pressure.
- Payer negotiations could further reduce net prices.
Regulatory and Policy Environment Impact
- The U.S. Inflation Reduction Act (2022) targets drug price transparency and negotiation.
- CMS initiatives focus on value-based pricing, potentially impacting high-cost therapies like Ocrevus.
- International markets have differing regulations, affecting global prices.
Key Takeaways
- The U.S. market size for Ocrevus is approximately $4 billion annually, with room for growth.
- Current list prices average around $63,000/year per patient.
- Market competition and policy shifts could constrain future pricing increases.
- Price declines are likely to be modest, with projections indicating stabilization or slight reductions through 2025.
- Biosimilars and increased biosimilar uptake elsewhere may eventually influence U.S. pricing strategies.
FAQs
1. What is the primary driver behind Ocrevus's market share?
Efficacy in both relapsing MS and primary progressive MS, along with an established safety profile, keeps Ocrevus dominant.
2. How might biosimilar entry affect Ocrevus prices?
Biosimilar entry could lead to significant pricing pressure, especially outside the U.S., but no biosimilars are approved or marketed in the U.S. yet.
3. Are there upcoming patent expirations?
No, patent protections extend beyond 2030, delaying generic biosimilar competition in the U.S.
4. What factors could cause prices to decrease faster?
Policy interventions, biosimilar approvals, or enhanced payer negotiations could accelerate price declines.
5. How does Ocrevus's pricing compare internationally?
Pricing varies widely—European and Asian markets often see lower costs due to regulatory and reimbursement differences.
References
[1] U.S. Food and Drug Administration. (2017). Ocrevus (ocrelizumab) approval letter.
[2] IQVIA. (2022). U.S. MS therapeutics market size and growth projections.
[3] FDA. (2022). Biosimilar and interchangeable products market analysis.
[4] Roche. (2023). Ocrevus prescribing information.
[5] CMS. (2022). Policy updates on drug pricing and negotiations.
