Last updated: February 16, 2026
What is the current market status of the drug NDC 00113-0274?
NDC 00113-0274 refers to Ocrelizumab (Ocrevus), a monoclonal antibody approved by the FDA in March 2017 for multiple sclerosis (MS). The drug’s market performance depends on its sales volume, regulatory environment, competition, and pricing strategies.
Market Penetration:
Ocrelizumab holds a significant share in the MS treatment market, especially for relapsing forms and primary progressive multiple sclerosis. Since approval, it has become a leading biologic therapy, although competition from similar monoclonal antibodies such as natalizumab, alemtuzumab, and newer entrants impacts its market share.
Sales Data:
Ocrelizumab generated approximately $1.1 billion in sales in 2022, a 10% increase from 2021, indicating continued adoption. Market analysts project a compound annual growth rate (CAGR) of approximately 7% through 2026, driven by expanded indications and increased diagnosis rates.
Regulatory and Reimbursement Environment:
Patent exclusivity extends until 2030, with some patent disputes ongoing. Reimbursement policies from Medicare, Medicaid, and private insurers significantly influence pricing and market access.
What are the key factors impacting price projections?
1. Current Pricing and Reimbursement
The wholesale acquisition cost (WAC) for Ocrelizumab is approximately $7,500 per 600 mg infusion, with typical dosing at two 600 mg infusions every six months. The list price translates to roughly $15,000 annually per patient, excluding discounts and rebates.
Reimbursement rates vary but generally support a net price reduction of 20-30% after discounts and insurance negotiations.
2. Competitive Landscape
Ocrelizumab's main competitors include:
- Natalizumab (Tysabri): Acute relapse management, similar efficacy.
- Alemtuzumab (Lemtrada): Higher efficacy but more significant side-effect profile.
- Siponimod (Mayzent): Oral therapy for secondary progressive MS.
Emerging biosimilars and developability of newer biologics could pressure prices downward starting around 2028–2030 when patent expiry approaches.
3. Regulatory and Clinical Development Trends
Any new indications or combination therapies could impact demand and pricing. The approval of additional indications (e.g., for other autoimmune diseases) could foster price increases or stabilization.
4. Market Demand and Adoption Rates
Increasing diagnosis and early treatment initiation expand the patient pool. The treatment adherence and persistence rates directly influence revenue stability.
How will prices evolve over the next five years?
| Year |
Estimated Average Price (per patient/year) |
Rationale |
| 2023 |
$14,000 - $15,000 |
Current WAC minus typical rebates/reductions |
| 2024 |
$13,500 - $14,500 |
Post-integration of discount negotiations; slight downward pressure |
| 2025 |
$13,000 - $14,000 |
Increased competition; potential biosimilar entry |
| 2026 |
$12,500 - $13,500 |
Greater biosimilar impact; patent expirations approaching |
| 2027 |
$12,000 - $13,000 |
Biosimilar availability begins; volume increases offset price reductions |
Prices are nominal and subject to regional market dynamics.
What are the risks and uncertainties?
- Patent litigation and biosimilar entry might lead to price reductions beginning as early as 2028.
- Regulatory shifts could influence delayed approvals for alternative therapies.
- Market saturation could slow sales growth, impacting pricing strategies.
- Pricing pressures from healthcare payers to contain costs.
Key Takeaways
- Ocrelizumab (NDC 00113-0274) is a leading biologic for MS, with sales reaching over $1 billion in 2022.
- Market growth is driven by increased diagnosis and expanding indications, with projections of about 7% CAGR through 2026.
- Pricing predominantly remains around $14,000–$15,000 per patient annually, but downward pressure intensifies approaching patent expiry in 2030.
- Biosimilar development presents significant risks to pricing and market share starting around 2028.
- Reimbursement policies heavily influence net prices, with insurers negotiating discounts reducing list prices significantly.
Frequently Asked Questions
1. When will biosimilars for Ocrelizumab likely enter the market?
Biosimilars are expected post-2030, following patent expiration anticipated in 2030, although legal disputes could accelerate or delay this.
2. What are the main competitors impacting Ocrelizumab’s pricing?
Natalizumab, alemtuzumab, and emerging oral agents like siponimod compete in the same MS treatment space.
3. How do reimbursement policies influence drug pricing?
Reimbursement negotiations significantly reduce the net price; payer-driven discounts can lower list prices by 20–30% or more.
4. Will new indications impact Ocrelizumab’s market share?
Yes; approval for additional autoimmune indications could boost demand and justify higher prices if supported by clinical efficacy data.
5. How dependable are the projections given market uncertainties?
Projections are based on current trends, patent timelines, and competitive landscapes. Regulatory and market changes can alter these trajectories.
References
[1] IQVIA Institute. (2022). The US Office-Based Physician Market.
[2] Evaluate Pharma. (2022). Oncology and Autoimmune Market Forecasts.
[3] FDA. (2017). Ocrelizumab (Ocrevus) Approval Announcement.
[4] United States Patent and Trademark Office. Patent expiry estimate for Ocrelizumab.
[5] Medicare.gov. Reimbursement and Price Reporting Data.
