Last updated: March 13, 2026
What is the Drug NDC 65162-0754?
NDC 65162-0754 corresponds to Ocrelizumab (Ocrevus), a monoclonal antibody approved by the FDA in March 2017 for the treatment of multiple sclerosis (MS). Ocrelizumab is administered via intravenous infusion every six months.
Market Landscape
Market Size and Growth
- The global multiple sclerosis market valued at approximately $23 billion in 2022, with an expected compound annual growth rate (CAGR) of 3.8% through 2030 (Fortune Business Insights, 2023).
- Ocrelizumab captured around 25% of the US MS drug market in 2022, making it one of the top-selling MS therapies.
- The drug's sales reached approximately $4.4 billion in 2022, representing growth driven by increased adoption and expanded indications.
Competitive Environment
| Drug |
Indication |
Market Share 2022 |
Approved in |
Dosage & Administration |
Major Competitors |
| Ocrelizumab |
Relapsing and primary progressive MS |
25% |
2017 |
600 mg IV every 6 months |
Tecfidera, Aubagio, Mavenclad |
| Rituximab (off-label) |
MS (off-label) |
Variable |
1997 |
375 mg/m2 weekly for 4 weeks, repeat every 6-9 months |
-- |
| Ofatumumab |
Relapsing MS |
15% |
2020 |
20 mg SC monthly, more convenient for some patients |
Ocrelizumab |
Usage Trends
- Sales are driven by its efficacy in primary progressive MS (PPMS) and relapsing forms.
- The approval of ofatumumab and other biosimilars could influence future sales.
- Payers increasingly favor Ocrelizumab due to its efficacy profile.
Price Trends and Projections
Current Pricing
- List price per dose (2022): approximately $6,500.
- Total annual cost (assuming two doses): about $13,000.
- Net prices paid by insurers can be lower due to rebates and negotiations, estimated between $8,000 and $10,000 per year.
Historical Pricing Trends
- Since launch, price adjustments have been infrequent.
- Average annual list price increases hover around 3-5%, paralleling inflation and market factors.
- Discounting and rebates influence actual transaction prices significantly.
Price Projections (2023-2028)
| Year |
Estimated List Price per Dose |
Estimated Annual Cost |
Key Drivers |
| 2023 |
$6,700 |
~$13,400 |
Inflation, competitive pressures |
| 2024 |
$6,900 |
~$13,800 |
New competitors entering, patent challenges |
| 2025 |
$7,100 |
~$14,200 |
Price adjustments, coverage policies |
| 2026 |
$7,300 |
~$14,600 |
Biosimilar entries, market saturation |
| 2027 |
$7,500 |
~$15,000 |
Cost escalation, new indications |
Note: Actual prices depend on negotiations, rebates, and market dynamics; list prices serve as a proxy.
Regulatory and Market Dynamics Influencing Pricing
- Patent expiration scheduled for 2028 may permit biosimilar entry, potentially reducing prices.
- Payer policies favor cost-effective therapies, driving discounts.
- New formulations and administration routes (e.g., subcutaneous) could impact price structures.
- Expanded indications could sustain or elevate demand, supporting pricing stability.
Implications for Stakeholders
- Manufacturers: Continuation of patent protection through 2028 supports premium pricing; biosimilar competition expected to exert downward pressure afterward.
- Payers: Focus on negotiated discounts and formulary placement to manage rising drug costs.
- Investors: Revenue growth driven by current market share and new indication approvals; price erosion expected post-patent expiry.
Key Takeaways
- Ocrelizumab (NDC 65162-0754) remains a leading MS therapy with significant sales volume.
- The drug's price per dose is approximately $6,500, with annual costs around $13,000, subject to inflation and market forces.
- Entry of biosimilars post-2028 likely will reduce prices, influencing revenue streams.
- Market competition, regulatory changes, and reimbursement policies critically impact future pricing.
- Price elasticity will depend on the emergence of new therapies and payer strategies to control costs.
FAQs
Q1: When will biosimilars for Ocrelizumab likely enter the market?
A1: Patent protection expires in 2028, with biosimilar development underway, aiming for market entry shortly thereafter.
Q2: How does the pricing of Ocrelizumab compare to similar MS therapies?
A2: It is priced higher than some oral or subcutaneous therapies but reflects its efficacy in primary progressive MS and infusion convenience.
Q3: What factors could influence the cost of Ocrelizumab before patent expiry?
A3: Market competition, payer negotiations, policy changes, and formulation innovations.
Q4: Are there any new indications expected for Ocrelizumab?
A4: Currently, no supplemental approvals are announced. Future approvals could sustain or increase its market share.
Q5: How are payers utilizing Ocrelizumab in drug formularies?
A5: Payers favor it for primary progressive MS due to demonstrated efficacy, and it often holds preferred formulary status.
References
- Fortune Business Insights. (2023). Multiple sclerosis market size, share & trends analysis. https://www.fortunebusinessinsights.com
- IQVIA. (2022). Latest drug pricing analysis reports.
- U.S. Food & Drug Administration. (2017). Ocrelizumab approval. https://www.fda.gov
- Bright, R., & Kesselheim, A. S. (2021). Biosimilar competition in MS therapies. Journal of Managed Care Pharmacy, 27(4), 376–382.
