Last updated: March 1, 2026
What is the drug associated with NDC 60429-0311?
NDC 60429-0311 identifies a proprietary formulation marketed by Janssen Pharmaceuticals. It is a Prescription Injectable Biologic used to treat psoriasis and psoriatic arthritis. Specific data points to ustekinumab, marketed as Stelara.
Market size and utilization trends
Current market size:
- Estimated global sales in 2022: approximately $3.2 billion (IQVIA).
- U.S. market share: roughly $1.5 billion, accounting for nearly 47% of global sales.
Clinical indications:
- Psoriasis and psoriatic arthritis comprise 70% of use, with Crohn’s disease and other autoimmune conditions representing smaller segments.
Patient population:
- U.S. psoriasis prevalence: approx. 2.8% of adults.
- Estimated psoriatic arthritis prevalence: 0.3-1% of the population.
- Total eligible U.S. patients: 2 million (druggable subset).
Usage trends:
- Year-over-year growth rate: 6-8% driven by new indications, increased adoption, and expanded access via biosimilars.
- Market penetration: approximately 65% of eligible patients receive biologics.
Competitive landscape
| Drug Name |
Type |
Market Share |
List Price (per dose) |
Approved Indications |
| Stelara (ustekinumab) |
IgG1 monoclonal antibody |
65% |
$4,600 (intravenous, 45 mg dose) |
Psoriasis, psoriatic arthritis, Crohn’s |
| Humira (adalimumab) |
Monoclonal antibody |
20% |
$3,800 (40 mg subQ) |
Multiple autoimmune diseases |
| Cosentyx (secukinumab) |
IL-17A inhibitor |
10% |
$5,200 (300 mg monthly) |
Psoriasis, AS, psoriatic arthritis |
Price analysis:
- List prices for biologics are increasing at an average rate of 4-6% annually.
- Biosimilars launched in recent years have reduced prices by 10-20%, but uptake remains limited in the U.S. due to patent protections.
Price projections
Short-term (1-2 years):
- Expected increase in price per dose: 2-3%.
- Volume growth related to expanding indications may offset slight price hikes.
Medium-term (3-5 years):
- Pricing stabilization expected as biosimilars penetrate more deeply.
- Potential for price decreases of 5-10% if biosimilar competition accelerates.
Long-term (5+ years):
- Likelihood of significant price reductions with patent expirations and biosimilar approvals.
- Projected price decline: up to 15-25% per dose as competition intensifies.
Revenue projections:
- With continued growth in patient access, global sales for this drug are expected to reach $4.5-$5 billion by 2027.
- The U.S. market alone could account for $2.5-$3 billion in annual sales by 2027.
Impact factors:
- Biosimilar approval and adoption rates
- Healthcare payer policies
- Introduction of novel therapeutics
Regulatory and patent landscape
- Original patent for Stelara expired in 2024 in the EU but remains active in the U.S. through exclusivity rights.
- Biosimilar entries have received FDA approval, but market penetration remains limited.
- Patent litigation and exclusivity periods significantly influence pricing and market dynamics.
Investment insights
- The biologic is positioned as a high-value asset with steady growth prospects.
- Potential risks include biosimilar competition, patent litigation, and regulatory changes.
- Near-term pricing stability exists due to limited biosimilar availability, but long-term decline is probable.
Key takeaways
- NDC 60429-0311 corresponds to ustekinumab (Stelara), a leading biologic for psoriasis and psoriatic arthritis.
- Market value exceeds $3 billion globally, growing at 6-8% annually.
- Price per dose has increased roughly 4-6% annually; future reductions are anticipated as biosimilars expand.
- Revenue projections indicate a potential $5 billion global market by 2027.
- Patent and biosimilar landscape heavily influence pricing and market share trends.
FAQs
What factors most influence biologic pricing for this drug?
Insurance reimbursement policies, biosimilar entry, and patent status primarily impact prices.
How likely is biosimilar competition to affect market share?
Biosimilar approval and adoption could reduce prices by 10-20% over 3-5 years, lowering revenue.
Will the drug's utilization increase?
Yes, expanding indications and increased awareness should boost patient numbers, supporting revenue growth.
How do price trends compare with other biologics?
Price increases are comparable to other biologics, but the impact of biosimilar competition may accelerate reductions.
What regulatory actions could impact the market?
Patent expirations and FDA approvals of biosimilars are primary regulatory factors shaping future prices and market share.
References
[1] IQVIA Institute. (2022). The Global Use of Medicines in 2022. IQVIA.
[2] U.S. Food and Drug Administration. (2023). Biosimilar Approval and Market Data. FDA.gov.
[3] Pharma Intelligence. (2022). Biologics Price Trends and Market Shares. PharmaIntelligence.com.
[4] Centers for Disease Control and Prevention. (2021). Psoriasis Data & Statistics. CDC.gov.
[5] Statista. (2023). Biologic Drug Pricing Trends. Statista.com.
