Last updated: February 25, 2026
What is NDC 00075-0621?
NDC 00075-0621 corresponds to Humira (adalimumab). It is a biopharmaceutical produced by AbbVie, used primarily for autoimmune conditions such as rheumatoid arthritis, Crohn's disease, and psoriasis. Humira remains one of the top-selling biologic drugs globally.
Market Overview
Sales Performance
Humira generated approximately $20.7 billion globally in 2022[1]. Despite patent expirations in key markets, it retains a dominant position due to its broad indications and established market presence.
Patent Status
- Original patents expired in the U.S. in 2023.
- AbbVie secured extensive patent protections through secondary patents and formulations, extending market exclusivity until approximately 2029 in the U.S.
- Patent disputes, biosimilar entries, and regulatory approvals influence market dynamics.
Biosimilar Competition
- The U.S. Food and Drug Administration (FDA) approved biosimilars such as Amjevita (adalimumab-atto) and Cyltezo (adalimumab-adbm) starting in 2023.
- Market entry led to price reductions, but Humira maintained significant market share through various strategies.
Market Share and Adoption
- In 2022, Humira had approximately 70-80% of the U.S. biologic adalimumab market.
- Biosimilars combined captured roughly 15-20%, with potential for ongoing growth as patents expire fully.
Price Projections
Current Pricing
- In the U.S., list prices for a 40 mg pen are approximately $5,600 to $6,000 per injection.
- Contracted prices through pharmacy benefit managers (PBMs) are lower; discounted prices range from $3,000 to $4,500 per dose for insured patients.
Post-Patent Expiry Outlook (2023-2029)
| Year |
Estimated Wholesale Price (per dose) |
Market Share |
Remarks |
| 2023 |
$5,600 |
80% (pre-Biosimilar) |
Stable before biosimilar entry |
| 2024 |
$4,800–$5,200 |
50% (biosimilars start gaining share) |
Price declines accelerate |
| 2025 |
$4,000–$4,600 |
60–70% biosimilar presence |
Biosimilar uptake increases |
| 2026 |
$3,800–$4,200 |
75–85% |
Biosimilar share dominant |
| 2027 |
$3,600–$4,000 |
80–90% |
Competition reduces list price |
| 2028 |
$3,400–$3,800 |
90% |
Saturation of biosimilar use |
| 2029 |
$3,200–$3,600 |
90–100% |
Full biosimilar penetration |
Key Factors Impacting Prices
- Manufacturing costs: Biologics have high production costs; biosimilarity reduces these marginally.
- Market competition: Multiple biosimilars entering the market decline prices.
- Insurance negotiations: PBMs negotiate discounts, further lowering patient out-of-pocket costs.
- Regulatory environment: Extended patent protections impact pricing strategies.
Strategic Considerations
- AbbVie has pursued patent litigation and aggressive settlement strategies to prolong Humira’s market exclusivity.
- Launch of biosimilars in 2023 and beyond pressures list prices downward.
- Growth prospects for the drug hinge on biosimilar adoption rates and potential new indications.
Key Takeaways
- Humira (NDC 00075-0621) generated in excess of $20 billion globally in 2022.
- Patent expirations in the U.S. begin in 2023, leading to significant biosimilar entry.
- Price per injection is projected to decline by approximately 30%-40% over the next five years.
- Biosimilar competition will dominate the market by 2027, resulting in steep price reductions.
- Contracted prices through payers are already lower than list prices, some below $4,000 per dose.
Frequently Asked Questions
Q1: How soon will biosimilars replace Humira in terms of market share?
A1: Biosimilars are projected to comprise over 80% of the adalimumab market by 2027.
Q2: Will the list price of Humira decrease after biosimilars enter?
A2: Yes, list prices are expected to decline by approximately 30% to 40% over five years following biosimilar market entry.
Q3: How do biosimilars impact patient costs?
A3: Biosimilars drive down prices, reducing patient out-of-pocket costs, especially where insurance and PBM negotiations favor biosimilar utilization.
Q4: What regulatory actions influence Humira’s market longevity?
A4: Patent litigations, patent extensions, and biosimilar approvals are the primary factors.
Q5: Are there new indications that could sustain Humira’s revenue?
A5: Yes, regulatory approvals for additional indications could stabilize or boost revenue before biosimilar dominance.
References
[1] IQVIA. (2022). 2022 Biopharmaceutical Year in Review. IQVIA Reports.
[2] U.S. Food and Drug Administration. (2023). Biosimilar Approvals. FDA.
[3] AbbVie. (2023). Humira Product Label and Patent Information. AbbVie Corporate Site.
