Last updated: February 15, 2026
What Is NDC 00574-0118?
NDC 00574-0118 refers to a specific drug product, identified by the National Drug Code, which indicates manufacturer, drug strength, dosage form, and packaging. Based on available data, NDC 00574-0118 corresponds to Arzerra (ofatumumab), marketed by GlaxoSmithKline, approved for treating chronic lymphocytic leukemia (CLL) and related conditions.
Market Size and Sales Trends
Current Market Landscape
- Indication: Chronic lymphocytic leukemia (CLL).
- Market Players: Arzerra, Gazyva (obinutuzumab), Rituxan (rituximab).
- Market Size (2022): The global CLL drug market totaled approximately $10 billion.[1]
- Market Share: Arzerra holds an estimated 12% of the CLL biologic treatment segment in the U.S.[2].
Sales Data (2022-2023)
| Year |
Estimated Sales (USD Millions) |
Change Year-over-Year |
| 2022 |
600 |
— |
| 2023 |
720 |
+20% |
Note: Sales based on IQVIA data, adjusted for market share and new approvals.
Competitive Position
- Gazyva (obinutuzumab) leads with 45% market share within the biologic CLL space.[2]
- Arzerra’s sales growth correlates with increased off-label use and expanded indications.
Price Trends and Projections
Current Pricing
- Per Dose (2023): Approximately $3,200 for a 300 mg dose.
- Average Annual Treatment Cost: $60,000 to $70,000 per patient in the U.S.[3].
Price Drivers
- Manufacturing costs: Stable due to the monoclonal antibody complexity.
- Regulatory updates: Potential additional approvals may support further price stability or increases.
- Market Competition: Gazyva's lower dosing regimen (weekly for 7 weeks) and patent status influence pricing.
Price Projections (Next 3-5 Years)
| Year |
Estimated Per Dose Price |
Justification |
| 2024 |
$3,250 |
Slight increase due to inflation and manufacturing costs. |
| 2025 |
$3,300 |
Anticipated patent extensions or biosimilar entry. |
| 2026 |
$3,350 |
Potential negotiations with payers; patent expiry risk. |
| 2027 |
$3,400 |
Entry of biosimilar competitors might pressure prices down. |
Note: These projections assume no significant regulatory changes or biosimilar market penetration, which could significantly alter prices.
Regulatory and Policy Impact
- Patent Status: Patents on Arzerra in the U.S. expire around 2025-2026, opening the market to biosimilars.
- Biosimilar Entry: The first biosimilar for ofatumumab is expected around 2024-2025, which could reduce prices by 20-30%.[4]
- Healthcare Policies: Cost containment measures by CMS and private payers may influence reimbursement and pricing strategies.
Future Market Factors
- Expanded Indications: Potential approvals for additional hematologic or autoimmune conditions could increase demand.
- Technological Advances: Improved biosimilars and manufacturing efficiencies could decrease costs.
- Competitive Dynamics: Market shares may shift post-patent expiry, impacting pricing.
Key Takeaways
- NDC 00574-0118, representing Arzerra, commands an annual treatment cost of approximately $60,000-$70,000.
- Sales are growing at around 20% annually, driven by increased adoption within the CLL market.
- Price per dose is expected to rise modestly over the next five years, with the possibility of significant reductions post-biosimilar entry.
- Market competition from biosimilars and policy changes will influence long-term pricing and market share.
- Patent expiration around 2025-2026 poses the greatest risk and opportunity for price adjustments.
FAQs
Q1: How does biosimilar entry affect the price of ofatumumab?
A: Biosimilar entry typically reduces prices by 20-30%, depending on market uptake and competition.
Q2: What are the main drivers of Arzerra's current market share?
A: Its proven efficacy for CLL, established safety profile, and regulatory approvals sustain its position despite competition.
Q3: How long is the patent protection for Arzerra?
A: Patents expire around 2025-2026 in the U.S., opening the market for biosimilars.
Q4: What regulatory factors could impact pricing?
A: FDA approvals for additional indications and biosimilar approvals significantly influence pricing strategies.
Q5: What is the potential impact of healthcare policy reforms?
A: Cost containment measures could pressure drug prices and favor biosimilar utilization over originator biologics.
References
[1] IQVIA Data, 2022.
[2] EvaluatePharma, 2023.
[3] Drug Channels Institute, 2023.
[4] FDA Biosimilars Report, 2023.
