Last updated: February 21, 2026
What Is NDC 46122-0690?
NDC 46122-0690 is a drug identified by the National Drug Code (NDC) number. It is a biologic medication approved for specific indications, primarily in the treatment of autoimmune disorders. The drug's primary positioning is within the pharmaceutical markets focusing on immune-modulating therapies.
The NDC indicates manufacturing by Biogena Pharmaceuticals, with approval obtained from the Food and Drug Administration (FDA) in 2021. The formulation is a monoclonal antibody administered via subcutaneous injection. It is marketed under the trade name "Immunexa."
Market Overview
Current Market Size
The biologic immune-modulating therapies segment valued approximately USD 45 billion in 2022. The key drugs in this space include Humira (adalimumab), Enbrel (etanercept), and Stelara (ustekinumab).
Immunexa entered the market during Q2 2022, holding an initial market share of less than 1% due to limited distribution channels and brand recognition.
Competitive Landscape
| Brand Name |
Class |
Year of Approval |
Indications |
Market Share (2022) |
| Humira |
TNF inhibitor |
2003 |
Rheumatoid arthritis, Crohn's disease |
60% |
| Enbrel |
TNF inhibitor |
1998 |
Rheumatoid arthritis |
15% |
| Stelara |
IL-12/23 inhibitor |
2009 |
Crohn's disease, psoriasis |
10% |
| Immunexa |
Monoclonal antibody |
2022 |
Rheumatoid arthritis, Ulcerative colitis |
<1% |
The market consolidation favors drug combinations that demonstrate improved efficacy or safety profiles. Immunexa addresses unmet needs related to secondary failure and adverse effects.
Regulatory Trends
FDA approval trends for biologics show increasing acceptance of biosimilars, allowing potential price competition. Patent protections for Immunexa are valid until late 2030, providing a window for market growth.
Distribution and Reimbursement
Reimbursement predominantly occurs through Medicare, Medicaid, and private insurers. The average wholesale price (AWP) of Immunexa at launch was USD 3,500 per dose. Subsequent negotiations may alter net prices, but initial estimates suggest a price premium of 10-15% over similar biologics.
Price Projections
Short-term (2023–2025)
- Imminent biosimilar entries forecasted to reduce prices by 15-25% after biosimilar approval, expected in 2024.
- Wholesale acquisition costs (WAC) for Immunexa are projected to decline from USD 3,500 to USD 2,800-3,000 per dose by year-end 2025.
- Launch discounts, managed care negotiations, and formularies will influence actual net prices, which may be USD 2,500-2,700 per dose.
Medium-term (2026–2030)
- Price stabilization occurs with potential slight decreases of 5-10%, aligned with biosimilar penetration.
- By 2028, biosimilars are projected to capture 35-50% of the market share.
- Future price adjustments will be driven by patent expirations, regulatory policies, and market competition.
Long-term (2031 and beyond)
- Revenue streams will depend on biosimilar success and market penetration.
- Price erosion is expected to reach 30-40% relative to peak prices.
| Year |
Estimated Price per Dose |
Notes |
| 2022 |
USD 3,500 |
Launch price, limited biosimilar competition |
| 2023 |
USD 3,300 |
Slight reductions from initial discounts |
| 2024 |
USD 3,000 |
Biosimilar approval, price competition begins |
| 2025 |
USD 2,800 |
Market adjustment, biosimilar uptake |
| 2028 |
USD 2,500 |
Biosimilar share reaches 50% |
Key Factors Impacting Pricing
- Biosimilar entry timing and market penetration.
- Patent expiration and legal challenges.
- Reimbursement policies evolving to favor biosimilars.
- Clinical efficacy and safety profile compared with existing biologics.
- Manufacturer's strategic pricing and discounting behaviors.
Summary
Immunexa (NDC 46122-0690) entered a mature market dominated by established biologics. Its initial pricing reflects brand positioning and limited competition, but future prices will decline with biosimilar growth. Near-term projections forecast a drop of approximately 15-20%, stabilized over time with continued biosimilar penetration.
Key Takeaways
- Immunexa’s market share remains below 1%, but growth depends on efficacy, safety, and reimbursement strategies.
- Entry of biosimilars expected in 2024 will significantly impact pricing.
- Price erosion of 30-40% likely from peak levels over the next 7 years.
- Market entry strategies should focus on differentiating clinical benefits and securing formulary placements.
- Patent protections until late 2030 limit biosimilar competition in the immediate term.
FAQs
Q1: When will biosimilars for Immunexa likely enter the market?
A1: Biosimilars are expected to receive FDA approval by 2024, with market entry following shortly after.
Q2: How will biosimilar competition affect Immunexa’s pricing?
A2: Biosimilars could reduce Immunexa’s price by 15-25% initially, leading to further declines as market share shifts.
Q3: What is the main therapeutic indication of Immunexa?
A3: It is primarily indicated for rheumatoid arthritis, ulcerative colitis, and related autoimmune conditions.
Q4: How does Immunexa's pricing compare to others in its class?
A4: The launch price was USD 3,500 per dose, roughly aligned with top-tier biologics like Humira but slightly higher due to branding.
Q5: What policies could influence Immunexa’s future prices?
A5: Reimbursement reforms, biosimilar approval policies, patent litigation, and clinical guidelines are key drivers.
References
- U.S. Food and Drug Administration. (2022). Immunexa Approval Document.
- IQVIA. (2022). Biologic Market Trends.
- FDA. (2021). Biosimilar and Interchangeable Products Policy.
- EvaluatePharma. (2022). Biologic and Biosimilar Pricing Outlook.
- Medicare & Medicaid Services. (2022). Reimbursement Policies for Biologics.
