Last updated: February 20, 2026
What is NDC 00113-4368?
NDC 00113-4368 corresponds to Humira (adalimumab), a monoclonal antibody used to treat autoimmune conditions such as rheumatoid arthritis, psoriasis, Crohn’s disease, and ulcerative colitis. It is manufactured by AbbVie.
Market Overview
Market Size
Humira is the leading biologic therapy in the autoimmune drug segment. In 2022, its global sales reached approximately $21 billion. The US accounted for around $14 billion, representing 66% of total sales (IQVIA, 2023).
Competitive Landscape
Humira faces competition from biosimilars and biologics with similar indications:
- Biosimilars: Erelzi (etanercept-szzs), Amjevita (adalimumab-atto), and Hadlima (adalimumab-bwwd).
- Premium biologics: Enbrel and Stelara.
In the US, biosimilars began market entry in 2023, leading to price competition.
Patent and Regulatory Environment
Humira's primary patent expired in 2023 in the US, opening the market for biosimilar competition. However, AbbVie secured additional patents extending exclusivity until at least 2026 through patent litigation and formulation patents.
Market Dynamics
- Pricing Stability: The list price in the US was approximately $6,600 per month for a standard dose in 2022.
- Reimbursement: Managed care plans negotiate substantial discounts, reducing net prices.
- Access: Biosimilar entry has driven prices down in select regions, but uptake remains gradual due to prescriber and patient inertia.
Price Projections
Short-term (2023-2025)
- List Price Trend: No significant increase; maintains around $6,600/month, adjusted for inflation.
- Net Price: Likely to decline by 15–25% as biosimilar penetration increases, driven by negotiated discounts and rebate erosion.
- Market Share: Biosimilars could account for 40–60% of prescriptions by 2025, pressuring the originator price.
Mid-term (2026-2030)
- Price Adjustment: Further discounts could reduce net prices by an additional 10–20%, contingent on biosimilar adoption rates and market competition.
- Pricing Floor: Expected to stabilize around $4,500–$5,000 per month for the originator, subject to overall demand and reimbursement policies.
- Market Revenues: Decline of approximately 40–50% from peak levels due to biosimilar competition.
Long-term Outlook
- Emerging Biosimilars: Increased competition from next-generation biologics or improved biosimilars could further pressure prices.
- Pricing Cap: US negotiations and policies aimed at cost containment (e.g., Medicare price negotiations) may formalize price caps on biologics, including Humira.
Key Factors Impacting Future Pricing
| Factor |
Impact |
| Patent litigation outcomes |
Extension of exclusivity can maintain higher prices |
| Biosimilar market acceptance |
Faster adoption leads to rapid price declines |
| Reimbursement policies |
Government interventions could cap or reduce costs |
| Manufacturing advancements |
Lower production costs might lead to lower prices |
| Regulatory approvals of biosimilars |
Expansion into new indications increases volume |
Summary of Price Estimates
| Year |
Estimated Monthly Price (USD) |
Notes |
| 2023 |
$6,600 |
List price in the US; initial biosimilar entry begins |
| 2024 |
$5,800–$6,000 |
Price reduction due to biosimilar competition begins |
| 2025 |
$4,500–$5,000 |
Further discounts as biosimilar use increases |
| 2030 |
$4,500–$5,000 |
Stabilization at reduced levels, contingent on regulation and market acceptance |
Market Outlook Summary
Humira remains a significant revenue contributor despite biosimilar competition. Price erosion is expected to continue over the next five years, driven by market entry of biosimilars, managed care negotiations, and potential policy interventions.
Key Takeaways
- Original Humira prices are relatively stable but are expected to decline sharply following patent expiration and biosimilar entry.
- Biosimilar adoption accelerates price reductions, especially in the US, which accounts for the majority of revenues.
- Reimbursement strategies and patent litigation outcomes will influence the pace and extent of price erosion.
- Long-term projections suggest stabilization at approximately 20–30% below peak prices, with prices likely to hover around $4,500–$5,000 monthly in 2030.
- Future industry shifts toward next-generation biologics and policy reforms may impose additional pricing constraints.
FAQs
1. When did the patent for Humira expire in the US?
Humira’s primary patent expired in 2023, opening the market for biosimilar competition.
2. What are the main biosimilars competing with Humira?
Erelzi (etanercept-szzs), Amjevita (adalimumab-atto), and Hadlima (adalimumab-bwwd).
3. How much has biosimilar entry affected Humira prices?
Biosimilar entry has driven overall prices down, with net prices decreasing by up to 25% since 2023.
4. What factors could influence future price trajectories?
Patent litigation outcomes, biosimilar market acceptance, regulatory policies, and reimbursement negotiations.
5. What is the expected long-term price for Humira?
Prices are projected to stabilize around $4,500–$5,000 per month by 2030, contingent on market and regulatory developments.
Citations
[1] IQVIA. (2023). "Global Pharma Market Report."
[2] FDA. (2023). "Patent Status of Humira."
[3] EvaluatePharma. (2022). "Biologic Market Trends."
