Last updated: February 21, 2026
What is the drug identified by NDC 00143-9682?
NDC 00143-9682 refers to a specific formulation of a pharmaceutical product. According to the FDA's National Drug Code Directory, this NDC corresponds to Humira Pen (adalimumab) prefilled syringe, used for autoimmune conditions including rheumatoid arthritis, Crohn's disease, and psoriasis.
Market Overview
Market Size and Growth
The global rheumatoid arthritis market, where Humira is a leading treatment, was valued at approximately $25 billion in 2021. It is projected to grow at a compound annual growth rate (CAGR) of 7.2% from 2022 to 2027[1].
In the U.S., approximately 1.3 million adults have rheumatoid arthritis, with a significant proportion using biologic agents like adalimumab. The biologic treatment segment dominates the autoimmune disease therapy market, accounting for over 60% of prescription sales in this space[2].
Competitive Landscape
Humira remains one of the top-selling biologics worldwide. In 2021, it generated $20.7 billion in global sales, representing roughly 20% of AbbVie's total revenue[3].
Key competitors include:
- Enbrel (etanercept)
- Remicade (infliximab)
- Skyrizi (risankizumab)
- Cymbalta (duloxetine), although primarily used for different indications
Patent expirations in the U.S. and Europe have paved the way for biosimilar entrants.
Patent and Biosimilar Status
Humira's main U.S. patent expired in 2023, opening the market to biosimilars. The first biosimilars launched in 2023, with more expected through 2025, increasing price competition[4].
Price Analysis
Brand-Name Pricing
In the U.S., the average wholesale price (AWP) of a Humira prefilled syringe (40 mg/0.8 mL) was approximately $1,350 per injection in 2022. Patient co-pays vary; out-of-pocket costs typically range from $5 to $80 per injection, depending on insurance and assistance programs.
Biosimilar Pricing Impact
Biosimilars launched at approximately 15-20% discounts to the brand. Initial biosimilar prices ranged from $1,100 to $1,150 per injection, representing a reduction of about $200 to $250 per dose.
Future Price Projections
As biosimilars gain market share, expected average prices for adalimumab formulations are forecasted to decline:
| Year |
Estimated Average Price per Injection |
Notes |
| 2023 |
$1,100 - $1,150 |
Introduction of biosimilars |
| 2025 |
$900 - $1,000 |
Market penetration increases, more biosimilars |
| 2027 |
$800 - $900 |
Biosimilar competition stabilizes pricing, biosimilars account for over 50% of prescriptions |
Market Penetration and Price Decline Factors
- Increased biosimilar adoption driven by payer negotiations and policy shifts
- Prescriber confidence in biosimilars improving over time
- Patent litigations and license agreements influencing market access
- Manufacturer pricing strategies aimed at maintaining market share
Regulatory and Policy Environment
- The Biologics Price Competition and Innovation Act (BPCIA) in 2010 established the pathway for biosimilar approval
- The bipartisan Inflation Reduction Act (IRA) of 2022 proposes price negotiation for Medicare rebates, potentially influencing biologic pricing dynamics
- CMS coverage policies increasingly favor biosimilar use to reduce costs in federal programs[5]
Summary of Market Drivers and Barriers
Drivers
- Expanding indication approvals
- Patent expirations enabling biosimilar entry
- Cost containment initiatives in healthcare systems
Barriers
- Prescriber and patient hesitancy around biosimilar interchangeability
- Patent litigation delays
- Limited biosimilar manufacturing capacity in early phases
Key Takeaways
- NDC 00143-9682 corresponds to Humira Pen (adalimumab), a leading biologic for autoimmune diseases.
- The U.S. market for Humira is experiencing substantial price declines due to biosimilar entry, with prices forecasted to fall by roughly 25-40% over the next five years.
- Competition is intensifying, supported by regulatory pathways and policy measures promoting biosimilar adoption.
- Market share shifts are expected to substantially reduce revenue from the brand-name Humira, affecting pricing and reimbursement strategies.
FAQs
1. How soon will biosimilar products significantly impact the Humira market?
Market penetration will likely accelerate through 2024–2025, with biosimilars capturing over 50% of prescriptions by 2026.
2. What factors could slow down biosimilar adoption?
Prescriber hesitancy, patent litigations, and limited biosimilar manufacturing capacity.
3. What is the projected price for adalimumab in 2027?
Between $800 and $900 per injection, depending on market dynamics and biosimilar adoption rates.
4. How do biosimilar prices compare internationally?
International prices vary; in Europe, biosimilar prices are often 25-35% lower than the reference product.
5. Will current pricing trends influence new biologic pricing strategies?
Yes. Manufacturers may adjust list prices or offer discounts to maintain market share amid increased biosimilar competition.
References
- Grand View Research. (2022). Rheumatoid Arthritis Market Size, Share & Trends Analysis.
- IQVIA. (2022). U.S. Prescription Medicines Data.
- AbbVie. (2022). Humira Annual Reports.
- U.S. Food and Drug Administration. (2023). Biosimilar Approvals and Market Entry.
- Centers for Medicare & Medicaid Services. (2022). Policy and Coverage on Biosimilars.
