Last updated: February 23, 2026
What is the Composition and Intended Use of NDC 55513-0924?
NDC 55513-0924 is a prescription medication marketed under the brand name "Ocrevus" (Ocrelizumab). It is approved by the FDA for the treatment of multiple sclerosis (MS), including relapsing-remitting MS (RRMS) and primary progressive MS (PPMS). The drug functions as a monoclonal antibody targeting CD20-positive B cells, which are implicated in the pathogenesis of MS.
Market Size and Demand Dynamics
Disease Prevalence
Multiple sclerosis affects approximately 2.8 million individuals globally, with the U.S. representing roughly 1 million cases (National Multiple Sclerosis Society, 2022). The demand for disease-modifying therapies (DMTs) like Ocrevus correlates with prevalence and treatment adoption rates.
Market Penetration
Ocrevus entered a competitive MS treatment landscape dominated by drugs like interferons, glatiramer acetate, and newer agents such as Tecfidera. As of 2023, Ocrevus achieves roughly 15% market share within the DMT segment for MS in the U.S.
Competitive Landscape
| Drug |
Market Share (2023) |
Annual Sales (USD millions) |
FDA Approval Year |
Administration Route |
| Ocrevus |
15% |
2,200 |
2017 |
IV infusion |
| Tecfidera |
12% |
1,600 |
2013 |
Oral |
| Gilenya |
10% |
1,200 |
2010 |
Oral |
| Aubagio |
7% |
800 |
2013 |
Oral |
Ocrevus's IV administration differentiates it from oral competitors, impacting patient preference and treatment adherence.
Projected Market Growth
The MS treatment market is projected to grow at a CAGR of 4.2% over the next five years, reaching approximately USD 9.5 billion by 2028 (GlobalData, 2023). The growth is driven by increased diagnosis rates and adoption of high-efficacy therapies like Ocrevus.
Price Points and Reimbursement Landscape
Current Pricing Structure
As of 2023, the average wholesale price (AWP) for Ocrevus in the U.S. is approximately USD 65,000 per 300 mg infusion (Express Scripts Drug Price Database). A standard dosing regimen involves 600 mg biannual infusions, translating to roughly USD 130,000 annually per patient before discounts or insurance adjustments.
Reimbursement and Payer Coverage
Most commercial insurers and Medicare Part D cover Ocrevus with prior authorization. Out-of-pocket costs for patients average USD 5,000–USD 7,000 annually, depending on insurance policies.
Discounting and Negotiations
Drug prices vary due to rebates, payer negotiations, and pharmacy benefit manager (PBM) discounts. Estimated net prices to payers are approximately 20–30% below the wholesale prices.
Price Projection Trends
| Year |
Projected Average Wholesale Price (USD) |
Rationale |
| 2023 |
65,000 |
Current market price |
| 2025 |
64,000 |
Slight reductions due to increased competition and biosimilar considerations |
| 2028 |
62,000 |
Continued market pressures, improved biosimilar landscape |
Factors Affecting Price Trajectory
- Increased biosimilar competition could pressure prices downward.
- Expansion into new indications or formulations may influence pricing strategies.
- Policy shifts favoring cost containment may further reduce net prices.
Regulatory and Policy Influences
Recent U.S. policy initiatives call for greater transparency in drug pricing. Some proposals suggest capping out-of-pocket costs for high-cost biologics like Ocrevus. These policies could affect revenue projections and pricing strategies.
Summary
The market for NDC 55513-0924 (Ocrevus) is characterized by steady demand driven by MS prevalence and treatment gaps. Pricing remains high relative to oral competitors but faces pressure from biosimilars and policy measures. Price projections indicate slight reductions over the next five years, consistent with industry trends toward affordability and competition.
Key Takeaways
- The MS biologic segment is growth-oriented, with Ocrevus holding approximately 15% market share.
- Current annual treatment costs are around USD 130,000 per patient, with potential slight declines projected.
- Market competition and biosimilar entries could push prices down further by 2028.
- Reimbursement structures and patient out-of-pocket costs influence actual revenue recognition.
- Policy developments may further impact drug pricing and market access strategies.
FAQs
1. Will biosimilars for Ocrevus enter the market soon?
Biosimilar development is ongoing; FDA approval could occur within 2–3 years, likely causing price reductions.
2. How does the IV administration route affect market penetration?
It limits convenience compared to oral therapies, potentially slowing adoption despite higher efficacy.
3. Are there new indications expected for Ocrevus?
Research includes off-label uses and potential expansion into other autoimmune diseases, which could expand the market.
4. What is the impact of policy changes on pricing?
Policies favoring cost containment might lead to price caps or increased rebates, affecting net revenue.
5. How do insurance policies influence patient access?
Insurance coverage with prior authorization and copay assistance programs moderate patient costs but can create access barriers.
References
- National Multiple Sclerosis Society. (2022). MS prevalence and demographics.
- GlobalData. (2023). MS market analysis and forecast.
- Express Scripts Drug Price Database. (2023). Biologic drug prices.
