Last updated: March 8, 2026
What is the drug associated with NDC 59651-0016?
The drug with NDC 59651-0016 is Ocrevus (ocrelizumab), marketed by Genentech. It is a monoclonal antibody approved for multiple sclerosis (MS) treatment, including relapsing forms and primary progressive MS.
What is the current market size for Ocrevus?
The global multiple sclerosis (MS) therapeutic market was valued at approximately $28 billion in 2022, with biologics accounting for over 70%. Ocrevus represented a significant share, driven by its approval in 2017 and expanded indications.
Key market drivers:
- Increasing prevalence of MS globally, estimated at approximately 2.8 million cases (MS International Federation, 2022).
- Growing adoption of high-efficacy therapies, including Ocrevus.
- Off-label use expansion for other autoimmune conditions, though restricted by regulatory approvals.
Competition:
Major competitors include:
| Drug |
Approval Year |
Market Share (2022) |
Indication(s) |
| Ocrevus |
2017 |
40% |
Relapsing MS, Primary progressive MS |
| Tecfidera (dimethyl fumarate) |
2013 |
30% |
Relapsing MS |
| Mavenclad (cladribine) |
2019 |
8% |
Relapsing MS |
| Tysabri (natalizumab) |
2004 |
12% |
Relapsing MS |
What are the price points?
The wholesale acquisition cost (WAC) for Ocrevus in the U.S. has been approximately $65,000 to $70,000 per year per patient (CMS, 2022). Variations occur based on dosage, patient weight, and negotiated discounts.
Cost breakdown:
- Typical dosing regimen involves 600 mg every six months, with initial doses at 300 mg two weeks apart.
- Cost per treatment cycle: $32,500 to $35,000.
- Insurance coverage and patient assistance programs influence actual out-of-pocket costs.
How is the market projected to evolve?
Short-term (next 3 years):
- Demand for Ocrevus expected to grow at a compound annual growth rate (CAGR) of approximately 6%, driven by increased diagnosed cases and expanded prescribing by neurologists.
- Biosimilar entry unlikely within this period due to patent protections expiring around 2028.
Long-term (beyond 5 years):
- Potential price erosion of 10-15% if biosimilars or next-generation products enter the market.
- Pricing pressures from payers and increased competition may lead to discounts of 20-25%.
Regulatory and policy factors:
- Payer negotiations favor volume-based discounts.
- CMS and other payers are emphasizing value-based arrangements, including outcomes-based contracts.
What are the key pricing factors?
| Factor |
Impact |
| Patent protection |
Maintains premium pricing until around 2028 |
| Competition from biosimilars |
Could lead to a 20-25% price decline after 2028 |
| R&D costs |
Support sustained pricing for innovation |
| Regulatory environment |
Policies promoting biosimilar uptake |
| Payer strategies |
Trends towards discounts and managed care |
Summary
Ocrevus remains a high-price biologic within the MS market, with stable demand anticipated through 2025. Price projections suggest limited downward pressure until biosimilar competition materializes post-2028. Immediate volume growth is likely, with some margin compression expected later.
Key Takeaways
- The U.S. wholesale price for Ocrevus remains around $65,000–$70,000 annually.
- Market volume growth is driven by rising MS prevalence and key prescriber acceptance.
- Price erosion will likely begin post-2028 with biosimilar entrants, with discounts potentially reaching 20–25%.
- Competition from other biologics and recent approvals influences market dynamics.
- Payer strategies favor discounts and value-based arrangements, impacting net revenues.
FAQs
1. When is patent expiration for Ocrevus?
Patent protection is expected to end around 2028, opening pathways for biosimilar competition.
2. How do biosimilars impact price projections?
Biosimilars typically reduce biologic prices by 20–25% upon market entry, affecting Ocrevus’s premium pricing.
3. What are the main factors influencing drug pricing?
Patent status, competition, regulatory policies, manufacturing costs, and payer negotiations.
4. Is there potential for off-label use expansion?
While off-label application for other autoimmune conditions exists, regulatory restrictions and evidence requirements limit expansion.
5. How might regulatory changes affect the market?
Policies promoting biosimilar use and value-based agreements could accelerate price decreases and influence market share.
References
- MS International Federation. (2022). Atlas of MS. Retrieved from https://www.msif.org
- Centers for Medicare & Medicaid Services (CMS). (2022). Drug pricing reports.
- IQVIA. (2022). Market Intelligence for MS therapies.
