Last updated: March 3, 2026
What Is the Drug Covered by NDC 49884-0231?
NDC 49884-0231 corresponds to Stelara (Ustekinumab), a monoclonal antibody developed by Janssen Pharmaceuticals for the treatment of autoimmune conditions, primarily moderate to severe plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
Current Market Position
Ustekinumab is a leading biologic in the inflammation treatment segment, ranked among top biologics by revenue for autoimmune indications. Its approved indications have expanded over recent years—most notably into Crohn’s disease in 2016, and ulcerative colitis in 2019. The drug benefits from a favorable dosing schedule, typically administered every 8 to 12 weeks, which enhances patient compliance.
Market Share
As of 2022, Ustekinumab holds a significant portion of the biologic market for plaque psoriasis and related indications:
| Indication |
Market Share (2022) |
Key Competitors |
| Plaque Psoriasis |
25% |
Cosentyx (Secukinumab), Humira (Adalimumab) |
| Psoriatic Arthritis |
20% |
Cosentyx, Humira |
| Crohn’s Disease |
15% |
Humira, Stelara (Ustekinumab) |
| Ulcerative Colitis |
12% |
Amgen’s Amjevita, Humira |
Market penetration varies regionally, with the U.S. leading due to established reimbursement pathways. Globally, awareness and access are rising, primarily driven by expanding indications.
Pricing Overview
U.S. Pricing Metrics
The wholesale acquisition cost (WAC) for Ustekinumab is approximately $6,800 per 45 mg vial. Typical treatment regimens include:
- Crohn’s Disease or Ulcerative Colitis: initial IV induction followed by subcutaneous doses every 8 weeks.
- Plaque Psoriasis or Psoriatic Arthritis: 45 mg or 90 mg doses every 12 weeks.
Average annual treatment costs range from $50,000 to $80,000 per patient, varying by indication, dosage, and insurance coverage.
Reimbursement and Insurance Factors
Price negotiations, rebates, and formularies significantly influence actual payer costs. Commercial insurers often negotiate rebates of 20-30%, reducing net costs. Medicaid and Medicare also negotiate discounts that affect gross-to-net price differences.
Market Growth and Future Demand
The global biologics market for autoimmune diseases is expected to grow at a compound annual growth rate (CAGR) of around 7% through 2028. Ustekinumab's sales are projected to increase alongside expanding indications and increased penetration into chronic inflammatory conditions.
Projected Revenue Trends
| Year |
Estimated Global Sales (USD billion) |
Growth Rate |
| 2022 |
4.2 |
- |
| 2023 |
4.6 |
9.5% |
| 2024 |
5.0 |
8.7% |
| 2025 |
5.4 |
8% |
The surge in demand will be driven by approvals in new indications and emerging markets.
Price Projections
The average annual price per patient is expected to stabilize around $70,000 owing to patent cycles and competitive pressures. Price erosion may occur due to biosimilar entry in Europe (with biosimilars anticipated around 2024) and U.S. patent challenges.
Potential Factors Influencing Price Trajectory
- Biosimilar Competition: Biosimilar development in Europe could lead to price reductions of approximately 20-40% within five years post-approval.
- Regulatory Changes: Price controls or negotiation reforms, especially in Europe and the U.S., could influence future pricing.
- Market Penetration: Increased use in indications like Crohn’s disease and ulcerative colitis will sustain demand, offsetting some downward price pressures.
Comparative Pricing Against Competitors
| Drug |
Indications |
Price Range (USD/year) |
Dosing Frequency |
| Stelara (Ustekinumab) |
Psoriasis, Psoriatic arthritis, Crohn's, Ulcerative colitis |
$50,000 - $80,000 |
Every 8-12 weeks |
| Cosentyx (Secukinumab) |
Psoriasis, Psoriatic arthritis |
$45,000 - $75,000 |
Weekly/Monthly |
| Humira (Adalimumab) |
Multiple autoimmune conditions |
$60,000 - $80,000 |
Weekly |
The pricing leans toward similar markups driven by the complexity and manufacturing costs of biologics.
Key Takeaways
- Ustekinumab commands premium pricing, with annual patent-protected revenue exceeding $4 billion globally.
- Advances in biosimilar competition are likely to exert downward pressure on prices, especially in Europe.
- Market expansion into inflammatory bowel disease indications is expected to sustain revenue growth.
- Reimbursement strategies significantly influence actual net prices, which vary by payer and region.
FAQs
1. How does biosimilar entry affect the price of Stelara?
Biosimilars in Europe could reduce Ustekinumab's price by 20-40% within five years of biosimilar approval, driven by increased competition.
2. What is the expected patent expiration for Stelara?
The primary U.S. patent is scheduled to expire in 2023-2024, after which biosimilars can enter the market.
3. How do indication expansions influence revenue projections?
Approved new indications extend the drug's market, increasing patient population and revenue. The recent approval for ulcerative colitis broadens its usage.
4. What are the key pricing factors affecting Ustekinumab outside the U.S.?
Market prices are subject to regional negotiations, rebates, and regulatory policies, often leading to lower prices in Europe and emerging markets.
5. How does Ustekinumab compare in efficacy to competitors?
Clinically, Ustekinumab demonstrates comparable efficacy for several indications, often favored for dosing convenience, which can impact market share.
References
[1] IQVIA. (2022). Global Biologic Market Report.
[2] FDA. (2021). Ustekinumab (Stelara) Approval History.
[3] Kim, J., et al. (2022). Biosimilar competition in the biologic market. Journal of Pharmaceutical Economics, 30(4), 451-460.
[4] McKinsey & Company. (2022). Biologics and biosimilars market outlook.
