Last updated: February 20, 2026
What is NDC 11980-0228?
NDL 11980-0228 is a pharmaceutical product identified by the National Drug Code (NDC) 11980-0228. It is marketed as an injectable biologic, primarily used for autoimmune conditions, such as rheumatoid arthritis. Its active ingredient is infliximab, a monoclonal antibody targeting tumor necrosis factor-alpha (TNF-alpha).
Current Market Position
Infliximab products, including the NDC in question, have a consolidated market share within the biologics segment for autoimmune disorders. As of 2023, global revenues for infliximab exceeded $10 billion, driven by high prevalence rates of rheumatoid arthritis and Crohn’s disease.
Key Competitors
| Product Name |
Company |
Approximate Market Share (2023) |
Price Range (per 100 mg vial) |
Unique Attributes |
| Remicade (Infliximab) |
Janssen Biotech |
60% |
$2,300–$2,700 |
First FDA-approved infliximab |
| Inflectra |
Celltrion |
15% |
$1,200–$1,500 |
Biosimilar to Remicade |
| Renflexis |
Samsung Bioepis |
10% |
$1,250–$1,550 |
Biosimilar, approved in US, EU |
| NDC 11980-0228 (Generic/Biologic) |
Contract Manufacturer |
15% (Projected) in niche markets |
$2,000–$2,400 |
Similar efficacy, different branding |
Market Trends
- Biosimilar Competition: Biosimilars began entering the U.S. market around 2016. Their presence reduced infliximab prices by approximately 12-15% from peak levels.
- Patent Expirations: The primary patent for Remicade expired in 2018 in the U.S., opening the market for biosimilar competition, but some patents remain in different jurisdictions.
- Regulatory Approvals: Additional biosimilar products obtained FDA approval in 2020–2022, expanding choice and lowering prices.
- Pricing Factors: Payer negotiations, formulary inclusion, patient assistance programs, and indication approvals impact net prices.
Price Projection Analysis
Baseline Assumptions
- Product is marketed as a biosimilar with comparable efficacy and safety.
- Uptake increases by 10–15% annually over the next five years.
- Price reductions follow historical biosimilar trends (~10% annually), with occasional stabilization due to brand name competition.
Price Trajectory (Next 5 Years)
| Year |
Estimated Price per 100 mg Vial |
Notes |
| 2023 |
$2,200 |
Current market average |
| 2024 |
$2,000 |
Initiates adoption among payers |
| 2025 |
$1,800 |
Biosimilar market expansion |
| 2026 |
$1,620 |
Increased biosimilar competition |
| 2027 |
$1,460 |
Price stabilization as market matures |
| 2028 |
$1,310 |
Continued competition, patent landscape shifts |
Risk Factors
- Regulatory delays or denials affecting biosimilar approval.
- Patent litigation prolonging market entry.
- Manufacturing disruptions increasing costs.
- Market consolidation, reducing competitive pressure.
Key Takeaways
- The product, similar to established biosimilars, faces downward pressure on pricing due to biosimilar entry and patent expiries.
- Prices are projected to decline approximately 40-50% over five years, reaching around $1,300 per 100 mg vial.
- Market share gain for this product depends on biosimilar adoption rates and payer policies.
- Raw material costs and manufacturing efficiencies could influence price stability.
FAQs
1. How does biosimilar entry impact the market price of infliximab?
It typically causes market prices to decrease by 10-15% initially, with further reductions as competition intensifies and market share shifts.
2. What regulation trends could influence future pricing?
Faster FDA approval pathways for biosimilars and patent litigations could either accelerate price decreases or extend brand dominance.
3. How do reimbursement policies affect price projections?
Payer negotiations and formulary placements determine net prices, often leading to discounts for preferred products, impacting projected prices.
4. What factors could slow down the expected price decline?
Manufacturing complexities, supply chain disruptions, or delayed biosimilar approvals can maintain higher prices longer.
5. How does market share influence revenue projections for this NDC?
Increased market share can offset lower prices, but overall revenue depends on volume sales and payor acceptance.
References
- IQVIA. (2023). Biologic Market Analytics.
- FDA. (2022). Biosimilar Product Approvals.
- Evaluate Pharma. (2023). Biologic and Biosimilar Pricing Trends.
- Centers for Medicare & Medicaid Services. (2023). Reimbursement Policies for Biosimilars.
- IMS Health. (2022). Global Biologic Market Report.
