Last updated: February 13, 2026
Product overview
NDC 00186-0776 refers to a pharmaceutical product marketed by Johnson & Johnson, specifically the Stelara (ustekinumab) injection. This biologic is indicated for plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. Approved by the FDA and launched in 2009, Stelara is a long-acting monoclonal antibody targeting interleukin-12 and interleukin-23 pathways.
Market landscape
The biologic market for autoimmune diseases is highly competitive. Key competitors include:
- Humira (adalimumab): The highest-selling drug globally, with 2022 revenues exceeding $21 billion.
- Skyrizi (risankizumab): Another IL-23 inhibitor, launched by AbbVie in 2019; sales reached approximately $4.7 billion in 2022.
- Cosentyx (secukinumab): An IL-17 inhibitor, with sales around $2.2 billion in 2022.
- Taltz (ixekizumab): An IL-17 inhibitor, with revenues close to $2 billion in 2022.
Stelara's market share is approximately $4.4 billion annually (2022), across indications. It maintains a competitive position due to its efficacy profile and dosing schedule (every 8–12 weeks), which can enhance patient adherence.
Pricing structure
Market prices for Stelara vary by indication and payer contracts:
- Average wholesale price (AWP): Approx. $6,600 per 45 mg dose (administered every 12 weeks).
- Per-treatment cost: Approximately $19,800 for a typical 3-dose (quarterly) regimen.
- Average net price: Estimated to be 35% lower than AWP owing to negotiated discounts, rebates, and payor agreements; around $4,300 per dose.
Inflation-adjusted, the list price for a single 45 mg injection has remained relatively stable over recent years, with annual increases around 3%, in line with inflation and market trends.
Market growth projections
The autoimmune biologic segment is expected to grow at a compound annual growth rate (CAGR) of approximately 6% through 2030, driven by:
- Increasing prevalence of autoimmune diseases (e.g., a 2.4% annual rise in psoriasis cases globally).
- Expanding indications and off-label uses.
- Improved access and reimbursement policies favoring biologics.
Stelara's revenue is projected to maintain a steady growth rate, with potential for slight decline if biosimilar versions or generics enter the market (expected post-2023 for some biosimilars in the U.S.).
Biosimilar impact
While no biosimilar for Stelara has received approval as of early 2023, biosimilar competitors could challenge its market share post-expiry of patent exclusivity — expected around 2023–2024. If biosimilars enter the market:
- Price reductions of 20–40% are feasible.
- Market share could shift from 100% to 70–80%, depending on payer and prescriber uptake.
- Price erosion and increased competition could decrease revenue projections by 15–25% over 5 years.
Price projections (2023–2028)
| Year |
Estimated Per Dose Price |
Revenue Impact |
Key Assumptions |
| 2023 |
$4,300 |
Stable for now |
No biosimilar entry; steady demand |
| 2024 |
$4,100–$4,300 |
Slight decline |
Biosimilar approvals expected |
| 2025 |
$3,900–$4,200 |
Moderate decline |
Biosimilar market access opens |
| 2026 |
$3,700–$4,000 |
Continued decline |
Market saturation increases |
| 2027 |
$3,500–$3,800 |
Market stabilization |
Patent exclusivity wanes |
| 2028 |
$3,300–$3,700 |
Possible further decline |
Increased biosimilar competition |
Regulatory and market factors
- Patent protections expire around 2024 in the US, opening the door for biosimilars.
- Payer policies increasingly favor biosimilars, leading to downward pressure on prices.
- New indications or combination therapies could support sustained revenue.
Key sources
- IQVIA data on biologic revenues (2022).
- FDA approval and patent expiry schedules.
- Industry analyst reports on biosimilar market entry.
- Published payer policy analyses.
Key Takeaways
- The product's market is mature with annual revenues around $4.4 billion.
- Current prices are approximately $4,300–$6,600 per dose, influenced by rebates and discounts.
- Sales growth is expected to stabilize or decline slightly post-biosimilar entry.
- Price reductions of 20–40% are plausible if biosimilars gain market share.
- The biologic segment's CAGR is 6%, but dynamics will shift with patent expirations and biosimilar competition.
FAQs
What factors influence Stelara’s pricing in the US?
Payer negotiations, rebate structures, patent protections, and competitive biosimilars influence net prices. Regulatory approvals and indication expansions also impact pricing and demand.
How likely are biosimilars to affect Stelara’s market?
High probability post-2024, contingent on patent expiry and regulatory approval. Biosimilar market share could reach 20–30% within three years of entry, reducing revenue.
How does Stelara compare to its competitors?
It maintains a strong position due to its dosing frequency and efficacy profile, but faces competition from newer IL-23 inhibitors like Skyrizi, which gain preference in certain indications.
What is the outlook for Stelara’s revenue in the next five years?
Potential stabilization around current levels with slight growth until patent expiry, after which decline may accelerate due to biosimilar competition.
Are there new indications that could sustain prices?
Yes, approval of additional indications or combination therapies could sustain or increase demand, offsetting generic/equivalent competition pressures.
References
- IQVIA. (2022). Global Biologic Drug Revenues.
- FDA. (2022). Patent expiry schedules.
- MarketWatch. (2023). Biosimilar pipeline updates.
- EvaluatePharma. (2022). Oncology and immunology drug forecasts.
- U.S. CMS. (2022). Reimbursement policies for biologics.
[1] IQVIA data, 2022; [2] FDA patent status; [3] Industry reports; [4] Payer policies; [5] Market forecasts.
