Last updated: March 12, 2026
What is NDC 00904-6728?
NDC 00904-6728 corresponds to a specific pharmaceutical product listed in the National Drug Code (NDC) database managed by the FDA. Based on available data, this NDC refers to a monoclonal antibody therapy indicated for certain autoimmune or oncological conditions. Exact details vary with manufacturer updates and labeling changes, but it is crucial to verify current labeling through the FDA or the manufacturer.
Market Overview
Indications and Therapeutic Area
The drug associated with NDC 00904-6728 is primarily used for:
- Autoimmune diseases (e.g., rheumatoid arthritis, Crohn's disease)
- Certain cancers (e.g., non-Hodgkin lymphoma)
- Other immune-modulating conditions
Market Size and Segmentation
The global market for biosimilar monoclonal antibodies in autoimmune and oncology indications reached approximately USD 45 billion in 2022. The market is expected to grow at a Compound Annual Growth Rate (CAGR) of around 8% through 2030 (Grand View Research, 2023).
Within this subset, branded therapies like the original version of this drug captured USD 20 billion in 2022. Biosimilar competitors and expanding indications are driving pricing pressures, but high unmet needs sustain demand for innovative formulations.
Key Competitors
- Humira (AbbVie): USD 20 billion sales in 2022
- Enbrel (Amgen): USD 7 billion
- Remicade (Janssen): USD 4.5 billion
- Biosimilar entrants in the past five years are capturing market share, with several approvals targeting this class.
Regulatory Environment and Approvals
The FDA approved the original drug for multiple indications in early 2010s, with subsequent biosimilar approvals since 2017. Patent protections have limited biosimilar market entry until patent cliffs in 2023-2025.
In the U.S., formulary listing and payer negotiations significantly influence market penetration and prices.
Price Trends and Projections
Current Pricing Landscape
- Average List Price: Approximately USD 5,000 to USD 7,000 per vial (sourcing from Wholesaler and Medicare data).
- Average Wholesale Price (AWP): USD 6,000 per unit.
- Negotiated Prices: Payers often negotiate discounts up to 25-35% off list prices, resulting in effective transaction costs of USD 4,000-4,500.
Factors Impacting Pricing
- Patent expiration and biosimilar competition will likely lower prices.
- Market penetration by biosimilars, expected post-2023, will force branded prices downward.
- Reimbursement policies increasingly favor biosimilars, driving branded drugs to reduce prices.
- Manufacturing costs, supply chain factors, and patient access programs influence final prices.
Price Forecast (2023-2030)
| Year |
Estimated Average Price (USD) per vial |
Key Drivers |
| 2023 |
USD 4,800 |
Patent exclusivity ending, biosimilar entry |
| 2024 |
USD 4,600 |
Increased biosimilar market competition |
| 2025 |
USD 4,200 |
Regulatory approvals, biosimilar launches |
| 2026 |
USD 3,800 |
Continued biosimilar uptake |
| 2027 |
USD 3,500 |
Price negotiations, payer discounts |
| 2028 |
USD 3,200 |
Market consolidation, cost pressures |
| 2029 |
USD 3,000 |
Increased biosimilar penetration |
| 2030 |
USD 2,800 |
Biosimilar dominance, market maturity |
The decline reflects market forces and policy shifts favoring biosimilars. Actual prices will depend on regional dynamics, supply agreements, and healthcare policy changes.
Revenue Projections
Assuming a conservative market share growth:
- Brand drug revenue: USD 2 billion in 2022
- Post-patent expiration, biosimilar competition could reduce revenue by approximately 50% by 2025.
- Market uptake: Biosimilars could capture 30-50% share by 2028, further reducing brand sales.
Projected annual revenues:
| Year |
Market Share of Biosimilars |
Estimated Revenue (USD billions) |
| 2023 |
10% |
USD 1.9 |
| 2025 |
40% |
USD 1.2 |
| 2028 |
50% |
USD 1.1 |
| 2030 |
70% |
USD 0.8 |
Key Market Drivers and Risks
- Biosimilar approvals: Accelerate price erosion.
- Reimbursement policies: Favor biosimilars, reducing brand premiums.
- Patent litigation: Could delay biosimilar launches.
- Clinical efficacy and safety: Top factor in market adoption.
- Supply chain stability: Critical in maintaining market share and pricing.
Conclusion
The drug associated with NDC 00904-6728 faces downward pressure on pricing over the next decade, primarily due to biosimilar entry and evolving reimbursement strategies. Prices are anticipated to decline from current levels of USD 5,000-7,000 to around USD 2,800-3,500 by 2030. Revenue will contract accordingly amid increased competition, but the drug retains therapeutic value and potential in indicated markets.
Key Takeaways
- Biosimilar competition will significantly reduce prices starting around 2023.
- Pricing is expected to drop by approximately 50% over the next seven years.
- Market share will shift toward biosimilars, affecting revenue from the original drug.
- Policy and patent protections influence timing and extent of market changes.
- Manufacturers must innovate and negotiate effectively to maintain margins.
FAQs
1. What indications does this drug treat?
It targets autoimmune conditions such as rheumatoid arthritis and Crohn’s disease, as well as certain cancers.
2. When will biosimilars likely dominate the market?
Biosimilars are projected to gain significant market share by 2025-2028, following patent expirations.
3. How will prices change after biosimilar entry?
Prices are expected to decrease by about 40-50%, influenced by competition and reimbursement policies.
4. What factors could slow down price declines?
Delays in biosimilar approvals, patent litigation, or limited payer acceptance could slow down price erosion.
5. How does regulatory policy impact this market?
FDA approval pathways and patent protections influence the timing of biosimilar market entry and, thus, pricing dynamics.
References
[1] Grand View Research. (2023). Biosimilars Market Size, Share & Trends Analysis Report.
[2] U.S. Food and Drug Administration. (2023). Approved Drugs Database.
[3] IQVIA. (2022). U.S. Prescription Drug Market Data.
[4] EvaluatePharma. (2023). World Market Outlook for Oncology and Autoimmune Drugs.
