Last updated: February 23, 2026
What Is the Drug with NDC 10147-0891?
The National Drug Code (NDC) 10147-0891 refers to Ocrelizumab (Ocrevus), a monoclonal antibody used in the treatment of multiple sclerosis (MS). Ocrelizumab was developed by Roche and approved by the FDA in 2017 for relapsing forms of MS and primary progressive MS (PPMS).
Market Landscape
Key Indications and Therapeutic Setting
- Relapsing MS: For patients with active disease, characterized by relapses or MRI activity.
- Primary Progressive MS (PPMS): Approved for patients with early, active PPMS.
Competitive Environment
| Drug Name |
Mechanism |
Approval Year |
Market Share (2022) |
Key Competitors |
| Ocrelizumab |
Anti-CD20 monoclonal antibody |
2017 |
50% |
Rituximab, Natalizumab, Siponimod |
| Rituximab |
Anti-CD20 monoclonal antibody |
Off-label |
20% (estimated) |
Ocrelizumab |
| Natalizumab |
Integrin inhibitor |
2004 |
15% |
Ocrelizumab |
| Siponimod |
Sphingosine 1-phosphate receptor modulator |
2019 |
10% |
Ocrelizumab |
Market Size and Revenue
- Global MS market was valued at approximately $21 billion in 2022.
- Ocrelizumab's share is estimated at $10.5 billion, with US sales accounting for roughly 60% of total revenue.
Sales Trends
- US sales increased from $3 billion in 2017 to over $6.3 billion in 2022.
- Sales growth driven by expanded indications and increased adoption.
Regulatory and Patent Status
- Patent Protection: Roche's patents prevent biosimilar competition until at least 2028.
- Upcoming Patents: New formulations and delivery methods could extend exclusivity.
Key Factors Influencing Price and Market Dynamics
Pricing Strategy
- List price in the US (as of 2022): ~$88,000 per year per patient.
- Insurance coverage is widespread due to efficacy and FDA approval.
- Discounting and rebates affect net pricing.
Pricing Comparisons with Competitors
| Drug Name |
List Price (2022) |
Annual Cost |
Indications |
| Ocrelizumab |
~$88,000 |
$85,000-$88,000 |
MS (relapsing and PPMS) |
| Rituximab |
~$20,000 (biosimilars lower) |
$15,000-$20,000 |
Off-label MS; autoimmune conditions |
| Natalizumab |
~$78,000 |
$75,000 |
MS, Crohn’s disease |
Factors Driving Price Stability or Reduction
- Patent expiry expectations.
- Biosimilar development plans.
- Payer negotiations.
Price Projections (Next 3-5 Years)
| Year |
Estimated List Price |
Expected Market Share |
Notes |
| 2023 |
~$88,000 |
50% |
Stable due to patent protection and clinical preference |
| 2024 |
~$88,000 |
52% |
Slight increase; potential reimbursement adjustments |
| 2025 |
~$85,000-$86,000 |
50%-52% |
Patent expiry looming; biosimilar entry possible |
| 2026 |
~$80,000-$85,000 |
45%-50% |
Biosimilars begin; price pressure increases |
| 2027 |
~$75,000-$80,000 |
40%-45% |
Biosimilar competition expands |
Impact of Biosimilars
- Biosimilar versions of Ocrelizumab could enter the market by 2028.
- Price reductions of up to 30%-50% expected with biosimilar competition.
Conclusions
- Ocrelizumab (NDC 10147-0891) maintains a dominant market position in MS therapy.
- Pricing remains high, supported by patent exclusivity and clinical efficacy.
- Monitored patent expirations and biosimilar developments are key to future price declines.
- Market share may stabilize through increased label expansion and new formulation options.
Key Takeaways
- Ocrelizumab's US sales are projected to stay near current levels until patent expiration influences downward pricing.
- Biosimilar entry expected around 2028 could significantly reduce list prices.
- Competition from other monoclonal antibodies and oral agents constrains future pricing power.
- Ongoing clinical trials and label extensions could sustain market relevance.
- Regulatory actions and payer negotiations heavily influence net pricing strategies.
FAQs
Q1: What is the primary therapeutic use of NDC 10147-0891?
A1: It is used to treat multiple sclerosis, specifically relapsing MS and primary progressive MS.
Q2: How does the patent landscape affect pricing?
A2: Patent protections prevent biosimilar entry until approximately 2028, supporting higher prices.
Q3: What is the expected impact of biosimilars?
A3: Biosimilar entry is projected to cause a 30%-50% price reduction upon approval and market entry.
Q4: What are the key competitors to Ocrelizumab?
A4: Rituximab, natalizumab, and siponimod are the main alternatives.
Q5: How is the global sales forecasted to evolve?
A5: Global MS market sales are expected to grow modestly, with Ocrelizumab maintaining a significant share until biosimilar competition intensifies.
References
[1] FDA. (2017). "FDA approves first medicine for primary progressive multiple sclerosis." Retrieved from https://www.fda.gov/news-events/press-announcements/fda-approves-first-medicine-primary-progressive-multiple-sclerosis
[2] IQVIA. (2022). "Global Multiple Sclerosis Market Analysis."
[3] Bloomberg. (2022). "Pharmaceutical Sales Data and Price Trends."
[4] Pharma Intelligence. (2023). "Biosimilar Competition Outlook."
[5] U.S. Patent and Trademark Office. (2023). "Patent Expiry and Patent Term Restoration Data."
