Last updated: March 27, 2026
What is the Drug NDC 31722-0587?
NDC 31722-0587 identifies a specific pharmaceutical product. Based on available data, it corresponds to Stelara (ustekinumab) injection, 45 mg. Stelara is a monoclonal antibody targeting interleukin-12 and interleukin-23 pathways, primarily used for Crohn's disease, psoriasis, psoriatic arthritis, and ulcerative colitis.
Market Landscape
Indications and Market Size
Stelara's primary indications have driven its sales growth. As of 2022, the key markets include:
- Crohn’s disease: Addressed approximately 1.5 million patients in the U.S.
- Plaque psoriasis: Affects around 7.5 million Americans.
- Ulcerative colitis and psoriatic arthritis: Growing segments, with significant unmet needs.
Competitive Environment
Major competitors include:
| Product |
Mechanism of Action |
Annual Sales (2022) |
Strengths |
| Humira (adalimumab) |
TNF-alpha inhibitor |
$20.4 billion |
Established market presence, broad indications |
| Cosentyx (secukinumab) |
IL-17A inhibitor |
$4.9 billion |
High efficacy in psoriasis |
| Risankizumab (Skyrizi) |
IL-23 inhibitor |
$3.4 billion |
Strong response in Crohn's and psoriasis |
| Stelara (ustekinumab) |
IL-12/23 inhibitor |
$7.4 billion |
Long track record, expanding indications |
Stelara's unique dual cytokine targeting sustains its position amid growing competition, especially in psoriasis and Crohn’s.
Sales Trends
Since its launch in 2009, Stelara's annual sales have increased year-over-year. Growth drivers include:
- Expansion into new indications
- Extended dosing intervals
- Increasing prevalence of chronic inflammatory diseases
In 2022, U.S. sales estimates for Stelara reached approximately $4.0-4.2 billion, representing a 10-12% increase over 2021.
Regulatory and Patent Outlook
Stelara’s primary patents expired in the U.S. by 2018, with several biosimilars entering the market from 2021 onward. Despite biosimilar competition, Stelara retains a significant market share due to its established efficacy, safety profile, and clinician familiarity.
Price Analysis and Projections
Current Pricing
Official wholesale acquisition costs (WAC):
- Per 45 mg vial: Approximately $6,000 – $6,500
- Per dose (assuming 45 mg): Around $6,200
The actual patient cost varies based on insurance, rebates, and negotiations.
Market Penetration and Pricing Trends
Post-patent expiration, biosimilars entered the U.S. market from 2021, with initial discounts of 15-30% relative to the reference product.
Biosimilar pricing:
| Biosimilar Name |
Discount from Stelara ($/dose) |
Launch Year |
Market Share (2022) |
| Amjevita (amjevita) |
~20% |
2021 |
15-20% |
| Yuflyma (biosimilar) |
Unknown, expected to increase |
2023+ |
N/A |
Despite biosimilars, Stelara's list price remains stable due to brand loyalty and patient support programs, although net prices have trended downward due to rebates.
Future Price Projections (2023-2028)
Considering biosimilar competition, regulatory shifts, and demand trends, the following projections are reasonable:
| Year |
Estimated Wholesale Price (per 45 mg vial) |
Notes |
| 2023 |
$6,200 – $6,500 |
Stable, with minimal variation |
| 2024 |
$6,000 – $6,300 |
Slight downward pressure from biosimilars |
| 2025 |
$5,800 – $6,200 |
Increased biosimilar utilization |
| 2026 |
$5,700 – $6,000 |
Market consolidates further |
| 2027 |
$5,500 – $5,900 |
Price stabilization; biosimilar share grows |
| 2028 |
$5,250 – $5,750 |
Further biosimilar proliferation |
Revenue Impact
Assuming stable market share and patient volume, annual revenue for Stelara could decline from $4.0 billion to approximately $3.4 billion by 2028 due to price competition and biosimilar penetration.
Regulatory and Market Access Factors
- Biosimilar approvals: FDA approved biosimilars, e.g., Amjevita, started market entry in 2021.
- Market exclusivity: Recent patent losses reduce barriers to biosears but maintain some protection via formulation and brand loyalty.
- Reimbursement policies: Insurers increasingly favor biosimilars to reduce costs, accelerating price adjustments.
Strategic Insights
- Continued expansion into additional indications (e.g., hidradenitis suppurativa) may bolster sales.
- Pricing pressures will persist, requiring manufacturer differentiation through efficacy, safety profiles, and patient support.
- Biosimilar uptake will be driven by provider and payer preferences, affecting long-term revenue.
Key Takeaways
- NDC 31722-0587 likely refers to the 45 mg formulation of Stelara, with sales at approximately $4 billion annually.
- Market competition from biosimilars is increasing, leading to proposed price declines of 5-10% annually.
- The drug remains a key player in inflammatory disease treatment but faces margin compression due to biosimilar entry.
- Pricing projections estimate a gradual decline in list prices, with net prices decreasing more sharply owing to rebates and negotiations.
- Strategic focus on expanding indications and differentiating through efficacy can mitigate revenue loss.
FAQs
1. How does biosimilar competition impact the price of Stelara?
Biosimilar entry typically reduces list prices by 15-30%, leading to lower net revenue for original biologics like Stelara.
2. Are there any upcoming patent protections or exclusivities for Stelara?
Most primary patents expired by 2018; secondary patents and formulations may extend some market protections until the late 2020s.
3. What are the main indications driving Stelara sales?
Crohn’s disease and psoriasis account for the majority of sales, with expanding off-label and additional indications increasing market size.
4. What factors could alter the pricing projections?
Regulatory changes, new biosimilar approvals, patents litigation, or significant efficacy breakthroughs could adjust price trajectories.
5. How does Stelara's market share compare to competitors?
Stelara maintains a strong position among IL-12/23 inhibitors but faces significant competition from IL-17 and IL-23 inhibitors like Cosentyx and Risankizumab.
References
- EvaluatePharma. (2022). Stelara sales data.
- FDA. (2021). Biosimilar approvals.
- IQVIA. (2022). U.S. pharmaceutical market analysis.
- Centers for Medicare & Medicaid Services. (2022). Rebate and reimbursement policies.
- Johnson & Johnson. (2022). Business updates and earnings reports.
