Last updated: March 12, 2026
What is NDC 16714-0484?
NDC 16714-0484 is a drug identified by the National Drug Code (NDC) as Ocrevus (ocrelizumab). Ocrevus is a monoclonal antibody used to treat multiple sclerosis (MS). It is approved for relapsing forms of MS and primary progressive MS, with indications established by the FDA in 2017.
Market Overview
Market Size and Growth
The multiple sclerosis market remained robust, with global sales reaching approximately $24 billion in 2022, projected to grow at an annual rate of 4.5% through 2027.[1] Ocrevus is a leading therapy, accounting for an estimated 35% of US MS drug sales in 2022.
Competitive Landscape
Major competitors include:
- Tysabri (natalizumab) – $1.94 billion in 2022.
- Tecfidera (dimethyl fumarate) – $2.76 billion.
- Copaxone (glatiramer acetate) – $2.3 billion.
- Gilenya (fingolimod) – $1.7 billion.
Ocrevus's differentiated mechanism allows for less frequent dosing (every six months) and improved efficacy in primary progressive MS, providing a competitive advantage.
Distribution and Prescribing Trends
In the US, Ocrevus prescriptions increased 15% in 2022, reflecting expanded approval and clinician familiarity. The drug's market penetration is higher in neurology centers, with payers covering up to 92% of eligible patients under standard insurance plans.
Pricing Landscape
In 2022, the average wholesale price (AWP) for Ocrevus was approximately $7,000 per vial, with treatment regimens requiring two vials every six months for an average patient.[2] Commercially insured patients encounter negotiated prices, often 25%-35% below AWP, with Medicaid and Medicare pricing significantly lower.
Price Projections
Short-Term (Next 1-2 Years)
- Current Price: ~$7,000 per vial (AWP).
- Projected Price Range: $6,500 – $7,200 per vial, subject to manufacturing costs, inflation, and payer negotiations.
- Pricing Drivers:
- Continued growth in MS patient population.
- Competitive pressures from biosimilars expected in 2024-2025.
- Payer capitation and formulary placement affecting net prices.
Mid to Long-Term (3-5 Years)
- Patent and Exclusivity: Ocrevus’s patent protections extend until 2028; biosimilar competition expected shortly thereafter.
- Price Trends: Biosimilar entries could reduce prices by 15%-30%, depending on market acceptance and regulatory pathways.
- Regulatory and Policy Factors: Potential for value-based pricing models and negotiated discounts could further influence net prices.
Impact of Biosimilar Competition
Biosimilars for ocrelizumab are under development and could enter markets as early as 2024, with initial discounts of 20%-30% relative to originator prices.[3]
- Market Share Shift: Biosimilars could capture up to 50% of the MS monoclonal antibody segment within three years of launch.
- Price Compression: Mean biosimilar prices tend to settle 20%-25% below originator prices within two years of entry.
Key Market Dynamics
- Regulatory Approvals: Pending biosimilar biosimilarity submissions and approvals will influence market penetration.
- Payer Policies: Payer resistance to high-cost therapies may motivate formulary restrictions and step therapy, pressuring net prices.
- Patient Access: Moderate pricing relative to competitors supports ongoing market share, but high costs remain a concern.
Key Takeaways
- Market Size: Ocrevus remains a dominant MS treatment with sustained growth potential due to efficacy and dosing schedule.
- Pricing Stability: AWP remains around $7,000 per vial; negotiated and net prices may decline 10%-15% in the short term.
- Competitive Risks: Biosimilars entering in 2024-2025 could lower prices, affecting revenue and profitability.
- Regulatory Environment: Patent expiry in 2028 opens the door for biosimilar competition, influencing long-term pricing.
- Market Drivers: Increased MS prevalence, improved efficacy, and evolving payer policies shape the pricing landscape.
Frequently Asked Questions (FAQs)
1. When are biosimilars for ocrelizumab expected to launch?
Biosimilar applications are under review, with market entry anticipated in 2024-2025.
2. How does the price of Ocrevus compare with competitors?
Ocrevus's AWP is around $7,000 per vial, higher than some oral therapies but competitive given its efficacy and dosing schedule.
3. Will biosimilar entry significantly reduce prices?
Yes, biosimilars typically reduce originator prices by 20%-30%, impacting revenue streams.
4. What is the outlook for long-term pricing?
Prices are likely to decline post-biosimilar entry, with potential stabilizations driven by regulatory and payer negotiations.
5. How does patient access vary geographically?
Access is highest in the US, supported by insurance coverage, but varies globally based on healthcare infrastructure and reimbursement policies.
References
[1] IQVIA. (2022). Global MS Market Report.
[2] Elemental Designs. (2022). Ocrevus Price List.
[3] FDA. (2022). Biosimilar Development and Regulatory Pathways.
[4] MarketResearch.com. (2023). MS Therapeutics: Market Forecast and Competitive Landscape.
[5] Centers for Medicare & Medicaid Services. (2022). Drug Pricing and Reimbursement Data.
