Last updated: March 8, 2026
What is the drug associated with NDC 65145-0167?
The NDC (National Drug Code) 65145-0167 corresponds to Ocrevus (ocrelizumab), indicated for multiple sclerosis (MS), particularly relapsing forms and primary progressive MS. Produced by Genentech (a Roche subsidiary), Ocrevus is a monoclonal antibody targeting CD20-positive B cells.
Current Market Landscape for Ocrevus
Market Size
- Global Multiple Sclerosis Market: Valued at approximately USD 24 billion in 2022.
- Ocrevus Market Share: Estimated at 25-30% within the MS biologics segment, making it one of the leading therapies in its class.
Competitors
| Drug Name |
Indication |
Annual Price (USD) |
Market Share (%) |
Notable Features |
| Ocrevus (ocrelizumab) |
Relapsing and primary progressive MS |
$65,000 - $70,000 |
~30% |
First approved for primary progressive MS |
| Kesimpta (ofatumumab) |
Relapsing MS |
$60,000 - $65,000 |
~10% |
Subcutaneous administration |
| Mavenclad (cladribine) |
Relapsing MS |
$60,000 - $65,000 |
~7% |
Oral administration |
| Tysabri (natalizumab) |
Relapsing MS |
$80,000 |
~15% |
Higher infusion frequency |
Usage Trends
- Growing adoption fueled by data showing efficacy in reducing relapse rates and disease progression.
- Shift towards earlier intervention in MS treatment protocols.
- Increasing approval for primary progressive MS expands market potential.
Pricing Trends
- List Price: $65,000 - $70,000 per year for standard dosing.
- Price Adjustments: Slight reductions in some markets due to biosimilar entry or pricing negotiations.
- Reimbursement: Secured through Medicare, Medicaid, and private insurers, with some variability across regions.
Price Projections (Next 3-5 Years)
| Year |
Expected List Price Range (USD) |
Key Factors |
| 2023 |
$65,000 - $70,000 |
Current pricing maintained; market stabilization |
| 2024 |
$63,000 - $68,000 |
Price negotiations with payers; biosimilar threats emerge |
| 2025 |
$60,000 - $65,000 |
Increased biosimilar market presence; price competition drives lower prices |
| 2026 |
$58,000 - $63,000 |
Biosimilars reduce pricing, market share shifts |
| 2027 |
$55,000 - $60,000 |
Biosimilar dominance intensifies; global market expansion |
Underlying Assumptions:
- Biosimilar approval and market penetration following non-originator entry expectations.
- Continued clinical data sustaining significant efficacy and safety.
- Regulatory policies allowing price flexibility and biosimilar uptake.
Regulatory and Policy Impact
- Biosimilar Market Entry: Anticipated biosimilar approvals in the US and EU around 2024-2025 could reduce prices by 15-30%.
- Health Policy Development: Price negotiations and formulary restrictions may lead to further price pressures.
- Reimbursement Trends: Payers favor biosimilars, driving negotiated discounts.
Sales and Revenue Outlook
- Projected US peak sales: USD 3-4 billion annually.
- Global market potential: USD 6-8 billion, assuming broader approval in underrepresented regions (e.g., Asia-Pacific).
- Market penetration influenced by physician preferences, insurance policies, and biosimilar competition.
Summary of Key Price Drivers
- Original pricing remains stable for 2023.
- Biosimilar competition will become more influential by 2024-2025.
- Market expansion and patent expiration will place downward pressure on prices.
- Payer policies, especially in Europe and the US, will shape price trajectories.
Final Considerations
Investors and R&D stakeholders should monitor biosimilar development pipelines, regulatory approvals, and payer negotiations, all of which directly impact drug pricing and market share.
Key Takeaways
- NDC 65145-0167 refers to Ocrevus, a leading MS biologic with USD 65,000-70,000 list price.
- Market size exceeds USD 24 billion globally, with substantial growth potential.
- Competition from biosimilars starting 2024-2025 could reduce prices by up to 30%.
- US and European reimbursement policies heavily influence pricing trends.
- Total global revenue could reach USD 8 billion by 2027 with market expansion.
FAQs
Q1: When will biosimilars for Ocrevus likely enter the market?
A1: Biosimilars are expected to gain regulatory approval by 2024-2025, with market entry following shortly after.
Q2: How will biosimilar entry affect Ocrevus's price?
A2: Biosimilar competition could lower list prices by 15-30%, depending on market acceptance.
Q3: Are there regions where the price is expected to remain higher?
A3: Yes, markets with less biosimilar penetration and limited reimbursement flexibility, like some Asian countries, might sustain higher prices longer.
Q4: What is the projected global revenue for Ocrevus in five years?
A4: Estimated USD 6-8 billion annually, assuming expanded approvals and consistent market share.
Q5: How does Ocrevus compare with competitor drugs in pricing?
A5: It is priced similarly to Kesimpta and Mavenclad but higher than some biosimilar options expected to launch soon.
References
- MarketWatch. (2022). Global Multiple Sclerosis Market Size, Share & Trends. Retrieved from https://www.marketwatch.com
- EvaluatePharma. (2022). 2022 Global Pharma Overview.
- FDA Drug Approvals. (2023). Biosimilar Approvals and Regulatory Pathways.
- IQVIA. (2023). Pharmaceutical Market Analytics and Pricing Trends.
