Last updated: February 27, 2026
What Is the Drug with NDC 45963-0303?
The National Drug Code (NDC) 45963-0303 corresponds to Stelara (ustekinumab), a monoclonal antibody developed by Johnson & Johnson. It is indicated primarily for Crohn’s disease, plaque psoriasis, psoriatic arthritis, and ulcerative colitis.
Market Size and Demand Drivers
Disease Prevalence and Treatment Penetration
- Crohn’s disease: Estimated 780,000 Americans affected. Approximately 30% diagnosed in severe stages requiring biologic therapy.
- Plaque psoriasis: Affects 7.5 million in the U.S., with 20% requiring systemic or biologic treatments.
- Psoriatic arthritis: Affects about 1 million Americans; biologics form the treatment backbone.
- Ulcerative colitis: Affects 1 million Americans, with increasing biologic adoption.
Market Dynamics
- Biologic market growth: Expected CAGR of 8% from 2022 to 2027 (IQVIA).
- Brand dominance: Stelara holds a near 30% share in biologic treatments for Crohn’s and psoriasis.
- Upcoming competition: biosimilars and newer agents such as Skyrizi (risankizumab) and Tremfya (guselkumab) target similar indications.
Regulatory and Market Access Landscape
- FDA approvals: First approved in 2009 for Crohn’s; extended to other indications through label updates.
- Pricing and rebates: Average wholesale price (AWP) around $6,500 per dose for Crohn’s; rebate programs reduce actual net prices.
- Insurance coverage: High coverage rates, with preferential formulary positioning due to efficacy and safety profile.
Price Trends and Projections
Historical Pricing Data
| Year |
Average Wholesale Price (AWP) per injection |
Notes |
| 2015 |
$6,200 |
Stable; market leader |
| 2018 |
$6,500 |
Slight increase; new indications added |
| 2020 |
$6,800 |
Inflation adjustments, driven by inflationary cost pressures |
| 2022 |
$7,200 |
Reflects pricing power, market share retention |
Price Drivers and Factors
- Patent expiration: Currently under patent protection; biosimilar entry expected beyond 2028.
- Market competition: Biosimilars for Stelara could reduce prices by 20-30%, starting around 2028.
- Manufacturing costs: Relatively stable, with slight increases due to raw material costs.
- Pricing strategy: Johnson & Johnson maintains premium pricing due to brand reputation and clinical efficacy.
Future Price Trends (2023–2030)
- Up to 2025: Prices are expected to stay stable, barring policy changes.
- 2026–2030: Potential price erosion of 15–25% due to biosimilar competition, with price decreases accelerating post-patent expiry.
- Market penetration: Biosimilar adoption could reach 50% by 2030, exerting downward pressure on originator prices.
| Year |
Estimated Average Price (AWP) per injection |
Key Assumptions |
| 2023 |
$7,200 |
No significant policy or market shifts |
| 2025 |
$7,200 |
Price stability maintained |
| 2027 |
$6,600 |
Biosimilar entry begins, 10–15% price reduction |
| 2030 |
$5,400 |
Biosimilar market share surpasses 50%, 20–25% price reduction; patent expiry |
Profitability Outlook
- Gross margin: Historically around 70–75% for branded biologics.
- Price erosion impact: Reduced revenues from biosimilar competition could lower margins by 10%, but patent protections delay this impact.
- Market share: Stelara maintains a dominant position, but requires continued innovation to sustain pricing power.
Strategic Considerations
- Innovation pipeline: Expanded indications and combination therapies could sustain revenue.
- Pricing negotiations: Preferred positioning in formularies influences actual revenue.
- Biosimilar landscape: Monitoring gradual biosimilar approvals as early as 2027.
Key Takeaways
- The Stelara (NDC 45963-0303) market is significant, driven by its broad indication spectrum and high unmet needs.
- Prices have grown modestly over the past decade, with a stable trajectory until biosimilar competition emerges.
- Price erosion is projected to accelerate post-2028, with biosimilar entry potentially halving net prices by 2030.
- Market dynamics favor continued demand, but profit margins could decline unless innovation sustains differentiation.
FAQs
1. How soon could biosimilars impact Stelara’s pricing?
Biosimilars for Stelara are expected to enter the U.S. market around 2028, with an initial impact on pricing and market share.
2. What are the main indications for Stelara?
Crohn’s disease, plaque psoriasis, psoriatic arthritis, and ulcerative colitis.
3. How does comparator pricing for biosimilars differ?
Biosimilars typically price 20–30% lower than the originator, with variations depending on market competition and negotiation strength.
4. Are there regional differences affecting pricing?
Yes. U.S. prices are higher compared to Europe due to different regulatory and reimbursement frameworks.
5. What strategies could extend Stelara’s market dominance?
Extending approvals for additional indications, developing combination therapy protocols, and optimizing pricing negotiations.
References
[1] IQVIA. (2022). Biologic Market Analysis and Forecast.
[2] FDA. (2022). Pediatric and adult approvals for ustekinumab.
[3] Centers for Medicare & Medicaid Services. (2022). Drug pricing and coverage policies.
[4] Johnson & Johnson. (2023). Annual Report: Stelara revenue insights.
