Last updated: March 2, 2026
What is NDC 00187-5146?
NDC 00187-5146 identifies a specific drug product, which, based on public records, corresponds to Humira (adalimumab), a monoclonal antibody used to treat autoimmune conditions such as rheumatoid arthritis, Crohn’s disease, and plaque psoriasis. This product is marketed by AbbVie.
Market Landscape
Market Size and Usage
- Global autoimmune therapy market was valued at over USD 13.5 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of approximately 8% through 2030.
- Humira accounts for about 40% of this market, given its widespread approval and established patents.
- U.S. sales in 2022: USD 20+ billion, representing roughly 60% of the drug's global revenues.
Competition
- Major competitors include Enbrel (etanercept), Remicade (infliximab), Skyrizi (risankizumab), and Cimzia (certolizumab pegol).
- Patent expirations: Humira’s original patents expired in the U.S. in 2016, with subsequent biosimilar launches beginning in 2023. The entry of biosimilars has eroded sales margins but remains a leading biologic due to brand loyalty and clinical reputation.
Regulatory Status
- Mostly approved across North America, Europe, Asia-Pacific.
- Patent exclusivity in the U.S. and Europe has ended or is ending, with biosimilar competition rising.
Price Trends and Projections
Current Pricing
- In the U.S., the average wholesale price (AWP) for a 40 mg/0.4 mL pen is approximately USD 5,500 to USD 6,000 per dose.
- The list price for a typical 40 mg dose has remained stable since biosimilar entries, but actual 30-day treatment costs are pressured downward due to insurance negotiations and biosimilar uptake.
Biosimilar Impact
- Entry of biosimilars in the U.S. commenced in late 2023; prices are expected to decline by 15-30% initially.
- Biosimilars are typically priced 15-25% lower than the originator; discounts increase over time as market share shifts.
Future Price Trends (2024-2030)
| Year |
Expected Humira Price per Dose |
Biosimilar Discount |
Estimated Market Share (Humira) |
Remarks |
| 2024 |
USD 5,500 |
20% fall |
50% |
Biosimilars gaining traction |
| 2025 |
USD 5,000 |
25% fall |
40% |
Biosimilar competition intensifies |
| 2026 |
USD 4,500 |
30% fall |
30% |
Market stabilizes at lower prices |
| 2027+ |
USD 4,000+ |
Trend stabilizes |
20% or below |
Market fully matured with biosimal dominance |
Revenue Impact
- Potential revenue decline by 50% over the next 3-4 years if biosimilar penetration reaches expectations.
- Price erosion mitigated by increased volume and expanded indications, including biosimilars’ demand-driven volume increases.
Strategic Considerations
- Patent litigation and exclusivity extensions can affect timing of biosimilar entry.
- Pricing policies led by insurers and government payers heavily influence the actual transaction prices.
- Reimbursement models may incentivize switching to biosimilars, compressing the profit margins for original biologics.
Key Takeaways
- NDC 00187-5146 corresponds to Humira, a leading biologic in autoimmune therapy.
- Market share is declining due to biosimilar competition, with prices projected to fall gradually.
- U.S. prices currently hover around USD 5,500 per dose; biosimilar discounts drive down costs progressively.
- Revenue declines are expected through 2026, but volumes may offset some financial impact if biosimilar adoption accelerates.
- Regulatory and patent dynamics will continue to shape market and pricing over the next several years.
FAQs
1. When will biosimilar competition significantly reduce Humira’s price?
Biosimilar market penetration is projected to accelerate in 2024-2025, leading to notable price reductions.
2. How much can prices decrease due to biosimilars?
Expected discounts range from 15% to 30% initially, increasing over subsequent years.
3. What are the key drivers for Humira’s sales going forward?
Market expansion into new indications, global access programs, and biosimilar adoption.
4. How does patent litigation influence pricing?
Patent disputes can delay biosimilar entry, maintaining higher prices longer. Settlement agreements or patent expirations eventually allow biosimilar competition.
5. Are there any regulatory risks for Humira?
Yes. Regulatory authorities may approve or reject biosimilar applications, and patent disputes remain a key risk factor.
References
- MarketResearch.com. (2023). Global autoimmune drugs market analysis.
- IQVIA. (2022). U.S. pharmaceutical pricing and sales data.
- FDA. (2023). Approvals and biosimilar regulations.
- EvaluatePharma. (2023). Biologic market projections.
- Abbott, AbbVie Securities filings. (2023). Patent and litigation updates.[1]
