Last updated: February 23, 2026
What Is the Drug NDC 51407-0049?
NDC 51407-0049 corresponds to Stelara (ustekinumab), a monoclonal antibody used to treat various autoimmune conditions, including psoriasis, Crohn’s disease, and ulcerative colitis. It was approved by the FDA in 2009 and is marketed by Janssen Biotech.
Market Penetration and Competitive Landscape
Current Market Status
- Indications: Psoriasis (FDA approved 2009), Crohn’s disease (2016), ulcerative colitis (2018), psoriatic arthritis.
- Market Share: Stelara captures approximately 25–30% of the biologic market for moderate-to-severe psoriasis in the U.S., with sales surpassing $7 billion globally in 2022.
- Key Competitors:
- Humira (adalimumab)
- Cosentyx (secukinumab)
- Tremfya (guselkumab)
- Skyrizi (risankizumab)
Growth Drivers
- Expanded indications, including ulcerative colitis.
- New dosing options improving patient compliance.
- Increasing prevalence of autoimmune diseases globally.
- Monotherapy benefits reducing need for adjunct treatments.
Challenges
- Patent expirations expected starting 2025.
- Biosimilar development impacting market shares.
- Pricing pressures from payers and healthcare providers.
Pricing Overview and Trends
Current Pricing Landscape (U.S. list prices)
| Product |
Year |
Approximate Annual Cost |
Notes |
| Stelara (ustekinumab) |
2023 |
$65,000–$70,000 |
Varies by indication and dosing frequency |
| Humira (adalimumab) |
2023 |
$66,000–$70,000 |
Biosimilar entry in 2023 impacting prices |
| Cosentyx (secukinumab) |
2023 |
$50,000–$60,000 |
Slightly lower than Stelara |
- Prices are typical retail list prices; actual payer costs are often lower due to negotiations, rebates, and discounts.
Price Trends and Projections
- Historical: Biologic prices initially increased due to R&D costs, branded dominance, and limited competition.
- Current: Pressures from biosimilars and healthcare reforms are reducing list prices.
- Projected:
- By 2025, average prices for ustekinumab are likely to decrease by 10–15% due to biosimilar competition.
- Prices may stabilize or decline further as biosimilars gain market share and rebate programs evolve.
- Payer negotiations could lead to discounts of 20–30% off list prices in the long term.
Patent and Regulatory Outlook
- Patent Expiry: The primary composition patent expired in 2023.
- Biosimilar Approvals: Several biosimilars approved in the U.S. and Europe, with more expected by 2025.
- Regulatory Pathways: Interchangeability status can influence biosimilar adoption and pricing.
Sales and Market Forecasts
| Year |
Global Sales (USD billion) |
Growth Rate |
Drivers |
| 2022 |
7.2 |
— |
Established indications, ongoing pipeline sales |
| 2023 |
7.5 |
+4.2% |
Continued market penetration, new indications |
| 2025 |
6.8–7.2 |
— |
Biosimilar competition, price adjustments |
| 2030 |
5.5–6.0 |
— |
Biosimilar share increasing, patent expirations |
Strategic Implications
- Investment Considerations: Companies with biosimilar development entering the market could significantly impact pricing and share.
- Pricing Strategy: Manufacturers should anticipate price reductions driven by biosimilar competition.
- Market Expansion: Clinical trial results and regulatory approvals for new indications will influence future growth.
Key Takeaways
- NDC 51407-0049 (Stelara) is a major player in the autoimmune biologic market with over $7 billion in sales.
- Price projections suggest a 10–15% decrease by 2025 as biosimilars enter the market.
- Patent expiry in 2023 will accelerate biosimilar competition, influencing long-term pricing.
- The U.S. market remains a critical driver, but global expansion, especially in Europe, offers future growth.
FAQs
What is the expected impact of biosimilar entry on Stelara prices?
Biosimilar entry is projected to reduce list prices of ustekinumab by 10–15% in the U.S. by 2025, with further discounts possible through rebates and formulary negotiations.
How do patent expirations affect the market for NDC 51407-0049?
Patent expiration in 2023 opens the market to biosimilar competitors, reducing revenue potential for the originator and increasing price competition.
What are the key drivers for Stelara sales growth through 2030?
Clinical expansion to new indications, increased global prevalence of autoimmune diseases, and improvements in dosing convenience support growth, despite biosimilar competition.
How do patient access programs influence pricing?
Rebate programs, coupons, and patient assistance reduce out-of-pocket costs but complicate the public list price trend.
Are there upcoming regulatory changes that could affect pricing?
Healthcare reforms aiming to control drug costs and ongoing biosimilar approvals could lead to further price reductions and market share shifts.
Citations
[1] U.S. Food and Drug Administration. (2022). Biological License Applications Approvals. Retrieved from https://www.fda.gov/drugs/types-applications/biologics-license-applications-bla.
[2] IQVIA. (2022). Biologic Market Analysis.
[3] FDA. (2023). Biosimilar Development and Approval. Retrieved from https://www.fda.gov/drugs/biosimilars.
[4] EvaluatePharma. (2022). World Preview of Biologic Market Trends.
[5] IMS Health. (2022). Pharmaceutical Market Data.
