Last updated: February 24, 2026
What Is NDC 31722-0141?
NDC 31722-0141 identifies a specific drug product within the National Drug Code Directory maintained by the FDA. This code corresponds to Ocrevus (ocrelizumab), indicated for multiple sclerosis and other autoimmune conditions. Ocrevus was approved by the FDA in March 2017 and is marketed by Roche.
Market Landscape
Indication and Patient Population
| Condition |
Prevalence (US) |
Estimated Patients |
Treatment Duration |
Annual Treatment Cost per Patient |
| Multiple sclerosis (Relapsing and Primary Progressive) |
1 million |
600,000 |
Bi-annual infusion |
$70,000–$80,000 |
| Autoimmune indications (off-label uses) |
Varies |
N/A |
N/A |
N/A |
Note: The primary population involves relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).
Competitive Landscape
- Key Competitors: Rituxan (rituximab), Kesimpta (ofatumumab), Mavenclad (cladribine)
- Market Share (2022): Ocrevus holds approximately 65% of the MS biologic market in the U.S., with Rituxan occupying the majority of off-label uses.
- Pricing Strategies: Roche prices Ocrevus around $65,000–$75,000 per infusion cycle in the US.
Regulatory Status
- FDA Approved: 2017 for RMS and PPMS
- Additional Approvals: EMA approval in 2018; ongoing trials for other autoimmune diseases.
Market Dynamics
- Growth Drivers:
- Increasing prevalence of MS.
- Shift towards biologic therapies with longer dosing intervals.
- Expanded indications in autoimmunity.
- Challenges:
- High treatment costs impacting accessibility.
- Competition from biosimilars (expected in late 2020s).
Price Trend and Projections
Historical Pricing Trends
| Year |
Average Price per Infusion |
Notes |
| 2017 |
$65,000 |
Initial launch price |
| 2019 |
$68,000 |
Slight increase due to market adjustments |
| 2021 |
$72,000 |
Price stable with minor fluctuations |
Future Price Estimates (2023–2028)
| Year |
Projected Price per Infusion |
Factors Influencing Price |
| 2023 |
$74,000 |
Inflations, market demand |
| 2024 |
$75,500 |
Potential biosimilar entry delay |
| 2025 |
$76,000 |
Market stabilization |
| 2026 |
$76,500 |
Biosimilar competition pressures mounting |
| 2027 |
$77,000 |
Potential price erosion due to biosuncio |
Note: Biosimilar competition expected by 2028–2030 could reduce pricing by approximately 20–30%, depending on market acceptance and patent litigations.
Revenue Projections
Based on current market share and pricing:
| Year |
Estimated U.S. Revenue |
Comments |
| 2022 |
$4.2 billion |
Based on 600,000 patients, biannual dosing |
| 2023 |
$4.4 billion |
Slight increase from demand growth |
| 2024 |
$4.5 billion |
Marginal growth amidst biosimilar competition |
| 2025 |
$4.6 billion |
Plateau expected without biosimilar impact |
| 2028 |
$4.8 billion |
Potential decline with biosimilars introduced |
Key Risks
- Entry of biosimilars could halve prices.
- Regulatory changes affecting reimbursement.
- Competitive advances in small-molecule oral treatments.
Strategic Implications
- Roche should monitor biosimilar development closely, especially the timing of patent expiry.
- Pricing strategies may need adjustments post-biosimilar entry.
- Expansion into new autoimmune indications could sustain revenue streams.
Key Takeaways
- NDC 31722-0141 corresponds to Ocrevus, a leading MS biologic.
- The U.S. market generated over $4 billion in revenue in 2022.
- Price per infusion hovered around $70,000–$75,000 with minimal fluctuations.
- Biosimilar competition is expected to emerge between 2028 and 2030, possibly reducing prices by 20–30%.
- Revenue growth will depend on market expansion, regulatory changes, and biosimilar developments.
FAQs
1. How does Ocrevus differ from competitor therapies?
It offers less frequent dosing (bi-annual infusions) and clinically proven efficacy for RMS and PPMS, positioning it as a preferred biologic despite higher costs.
2. When is biosimilar competition expected?
Generally between 2028 and 2030, contingent on patent litigation and regulatory approval timelines.
3. How are prices affected by reimbursement policies?
Reimbursement policies from payers influence pricing strategies and patient access; increased rebate pressures may lower net prices.
4. What is the outlook for non-U.S. markets?
The European market is similar, with slight variances in pricing and approval timelines. Emerging markets may see delayed adoption owing to affordability issues.
5. What are the primary factors influencing Ocrevus's market share?
Efficacy, safety profile, dosing frequency, pricing, and competitors' biosimilars.
References
[1] FDA. (2017). Ocrevus approval announcement. https://www.fda.gov
[2] IQVIA. (2022). U.S. Biosimilar Market Report.
[3] EvaluatePharma. (2022). Global Oncology & Autoimmune Market Data.
[4] Roche. (2022). Annual Report.
[5] IMS Health. (2022). U.S. Biologics Market Analysis.
Note: Data and projections are approximations based on current trends, market reports, and publicly available filings.
