Last updated: February 23, 2026
What is NDC 76282-0571?
NDC 76282-0571 identifies a specific drug product. Based on available data, this NDC corresponds to Stelara (ustekinumab), a monoclonal antibody used to treat autoimmune conditions such as Crohn’s disease, ulcerative colitis, psoriatic arthritis, and plaque psoriasis.
Market Size and Growth
Current Market Size
In 2022, the U.S. biologics market for autoimmune diseases was estimated at approximately $60 billion. Stelara's share reached roughly $8.4 billion, accounting for around 14% of biologics for immune-mediated conditions [1].
Market Drivers
- Increasing prevalence of Crohn’s disease and psoriasis [2].
- Expansion of indications, including new approved age groups.
- Growth in biologics adoption over small molecules.
- Patent exclusivities and biosimilar entry timelines.
Competitive Landscape
Key competitors include Humira (adalimumab), Remicade (infliximab), Skyrizi (risankizumab), and Tremfya (guselkumab).
| Product |
2022 Revenue |
Market Position |
Patent Status |
| Stelara (Ustekinumab) |
$8.4B |
Leading in psoriatic indications |
Patent till 2023; biosimilar entry expected |
| Humira (Adalimumab) |
$21B |
Largest biologic in autoimmune |
Patent expired; biospections available |
| Skyrizi (Risankizumab) |
$4.5B |
Growing competitor |
Patent till 2030 |
Patient Demographics
Estimated U.S. patient population:
- Crohn’s disease: 1.6 million
- Psoriasis: 7 million
- Psoriatic arthritis: 400,000
Market penetration is increasing with 20% of eligible patients on biologics.
Price Analysis
Current Pricing Benchmark
List price per dose (monthly):
- Stelara: approximately $7,300
- Annual therapy cost: ~$87,600
Reimbursement Trends
- Commercial insurers reimburse close to list prices.
- Medicaid and Medicare often negotiate discounts.
- Biosimilar competition expected to reduce prices by 15%-25% after patent expiration.
Biosimilar Impact
Expected biosimilar entries by 2023-2024 may lead to:
- Price reductions up to 25%
- Greater payer negotiation leverage
- Shift toward value-based contracting
Price Projections (Next 5 Years)
| Year |
Estimated Price per Dose |
Total Annual Cost |
Key Factors |
| 2023 |
$7,300 |
$87,600 |
Patent expiry; biosimilar entry begins |
| 2024 |
$6,950 (5% reduction) |
$83,400 |
Biosimilar competition intensifies |
| 2025 |
$6,180 (15% reduction) |
$74,160 |
Widespread biosimilar adoption |
| 2026 |
$5,500 (25% reduction) |
$66,000 |
Market stabilization; increased biosimilar use |
| 2027 |
$5,500 |
$66,000 |
Market stabilizes, new formulations possible |
Regulatory and Policy Impact
- Patent cliffs in 2023-2024.
- FDA biosimilar approvals increase competition.
- CMS may further incentivize biosimilar use.
Risks and Opportunities
Risks
- Slow biosimilar adoption.
- Pricing pressures from payer negotiations.
- Clinical trial failures delaying expansion.
Opportunities
- Expansion into new indications.
- Increased dosing flexibility.
- Adoption of biosimilar versions.
Key Takeaways
- NDC 76282-0571 (Stelara) holds substantial market share within autoimmune biologics.
- The market is driven by rising prevalence and biologic adoption.
- Price is approximately $87,600 annually before discounts.
- Patent expiration in 2023-2024 will likely lead to a 15-25% price reduction.
- Biosimilar competition will influence pricing, reimbursement, and market dynamics over the next five years.
FAQs
Q1: When will biosimilar versions of Stelara likely enter the market?
A: Biosimilars are expected to enter in 2023-2024, following patent expiration.
Q2: What are the primary indications for Stelara?
A: Crohn’s disease, ulcerative colitis, psoriatic arthritis, and plaque psoriasis.
Q3: How will market share shift after biosimilar entry?
A: Biosimilar adoption is projected to reduce Stelara’s price by 15-25% and may decrease market share concentration.
Q4: How does Stelara pricing compare to its competitors?
A: Stelara’s annual cost (~$87,600) is comparable to other biologics like Humira, which costs approximately $70,000–$80,000 annually.
Q5: What factors could affect future price projections?
A: Regulatory approvals, payer negotiations, clinical trial results, and biosimilar market entry.
References
[1] IQVIA. (2022). Pharmaceutical Market Report.
[2] CDC. (2022). Prevalence of autoimmune diseases in the US.
[3] FDA. (2022). Biosimilar approvals and patent statuses.
[4] GoodRx. (2023). Biologic drug price listings.
