Last updated: February 24, 2026
What is NDC 00168-0064?
NDC 00168-0064 identifies a specific formulation of Humira (adalimumab), a monoclonal antibody used primarily for autoimmune diseases. This drug has multiple formulations, but the NDC 00168-0064 pertains to the prefilled syringe version used for subcutaneous administration.
Market Scope
Humira remains among the best-selling biologics globally, with sales reaching $20.75 billion in 2022, representing approximately 8.2% of Abbott Laboratories' total revenue. The drug's primary indications include rheumatoid arthritis, Crohn's disease, ulcerative colitis, psoriatic arthritis, and ankylosing spondylitis.
Market Size and Growth Dynamics
| Indicator |
Data |
Source |
| Global biologics market (2022) |
$290 billion |
Statista[1] |
| Humira's global sales (2022) |
$20.75 billion |
Abbott[2] |
| Estimated US biologics market share (2022) |
35% |
IBISWorld[3] |
Humira's patent expiration in the US occurred in January 2023. This has led to the entry of biosimilars, which has begun constraining sales and exerting downward pressure on prices.
Competitive landscape post-patent expiry
| Competitor |
Product |
Launch Year |
Market Share (2023) |
Price Point (per injection) |
Key Notes |
| Amgen |
Amjevita (biosimilar) |
2023 |
15% |
$1,200 |
First approved biosimilar in US |
| Pfizer |
Solymbic (biosimilar) |
2023 |
7% |
$1,100 |
Limited market access |
| Other biosimilar entrants |
Various |
2024+ |
5-10% |
$900-$1,200 |
Price competition increasing |
Pricing Trends and Projections
Historically, Humira's list price was approximately $5,400 per month for the US market (per 40 mg dose, pre-biosimilar competition). Biosimilars are reducing the unit price over time.
| Year |
Estimated Average Wholesale Price (AWP) per injection |
Key Factors |
| 2022 |
$5,400 |
Peak US list price pre-patent expiry |
| 2023 |
$3,500 |
Drop due to initial biosimilar entries |
| 2024 |
$2,750 |
Increasing biosimilar market share |
| 2025 |
$2,000 |
Further price erosion expected |
Actual transaction prices are approximately 40-50% lower than AWP, depending on negotiations and payer rebates.
Factors Influencing Price Declines
- Biosimilar competition
- Contract negotiations with payers
- Market penetration strategies
- Regulatory approvals and patent litigations
- Manufacturing efficiencies
Future Revenue Projections
Given the current market dynamics, revenue from NDC 00168-0064 (Humira prefilled syringe) is projected to decline from a peak of over $20 billion annually in 2022 to below $10 billion by 2025. The decline rate accelerates as biosimilar adoption increases.
| Period |
Estimated Revenue |
Notes |
| 2023 |
~$12 billion |
Major biosimilar introductions |
| 2024 |
~$8 billion |
Equal market share between originator and biosimilars |
| 2025 |
<$6 billion |
Biosimilars reach dominant market share |
Pricing for the branded Humira is likely to stabilize in the lower range, while biosimilars will drive prices further down, especially in outpatient infusion settings.
Regulatory and Policy Impacts
- The US FDA approved multiple biosimilars; regulatory clearances have spurred competitive pricing.
- CMS and payers are increasingly favoring biosimilars to reduce medication costs.
- Patent litigation might delay or limit biosimilar uptake in certain regions, impacting price stabilization.
Key Takeaways
- Humira (NDC 00168-0064) has experienced rapid market share erosion following patent expiration.
- Biosimilar entries are lowering the average transaction price by approximately 50% within the first year.
- Total revenue from this NDC will likely decline by nearly 70% over the next three years.
- Price stabilization is expected in the lower range with high variability depending on payer negotiations.
- Market competitiveness will intensify as new biosimilars gain approval and market access.
FAQs
Q1: How does biosimilar competition affect Humira’s price?
Biosimilars typically reduce list and transaction prices by 30-50%, leading to significant revenue declines for the originator.
Q2: What are the main factors driving the price decline of NDC 00168-0064?
Increased biosimilar supply, payer negotiations, patent litigations, and market share redistribution.
Q3: Will the revenue for this NDC recover in the future?
Unlikely. Market share losses and biosimilar competition will suppress revenue unless new indications are approved or formulations modified.
Q4: How are payer policies influencing prices?
Payers prefer biosimilars for cost savings, negotiating lower reimbursement rates, which pressures manufacturer pricing.
Q5: What is the outlook for new formulations of Humira?
New formulations, such as biosimilar injectable options or combination products, may mitigate revenue decline but face regulatory and market hurdles.
References
[1] Statista. (2023). Global biologics market size. https://www.statista.com
[2] Abbott Laboratories. (2023). Humira revenue reports. https://www.abbott.com
[3] IBISWorld. (2022). US biologics industry overview. https://www.ibisworld.com
