Last updated: March 4, 2026
What Is NDC 67877-0626?
NDC 67877-0626 identifies Risperdal Consta (risperidone long-acting injection), a medication used for schizophrenia, bipolar disorder, and irritability associated with autism spectrum disorder. It is manufactured by Janssen Pharmaceuticals. Risperdal Consta is administered via intramuscular injection every two weeks.
Market Size and Growth Drivers
1. Patient Population
- Schizophrenia prevalence: approximately 1 in 100 adults globally.
- Bipolar disorder prevalence: around 1-2% of the population.
- Autism-related irritability: increasing recognition, with significant demand for long-acting atypical antipsychotics.
2. Market Penetration
- Major markets include the United States, Europe, and Japan.
- In the U.S., approximately 1 million patients receive long-acting antipsychotics annually.
3. Competitive Landscape
- Competitors include Abilify Maintena (armodafinil), Invega Sustenna (paliperidone), and Aristada (aripiprazole lauroxil).
- Risperdal Consta holds roughly 30-35% market share among long-acting injectable antipsychotics in the U.S.
4. Regulatory Status
- Approved for use since 2003.
- No recent regulatory updates that restrict or expand its indications.
5. Insurance and Reimbursement Trends
- Coverage in major markets reduces barriers.
- Increasing adoption correlates with efforts to improve adherence and reduce hospitalization costs.
Price Trends and Projections
1. Current Pricing Overview
| Region |
Average Wholesale Price (AWP) per injection |
Estimated Reimbursement Price |
Notes |
| U.S. |
$450 - $600 |
$300 - $500 |
Variability due to discounts and payor negotiations |
| Europe |
€350 - €500 |
€250 - €400 |
Dependent on country and pharmacy network |
| Japan |
¥45,000 - ¥60,000 |
¥30,000 - ¥50,000 |
Price adjustments driven by national health policies |
2. Market Pricing Dynamics
- U.S. prices have stabilized over the past three years, with minor increases aligned with inflation and packaging costs.
- Price erosion expected due to increased biosimilar competition anticipated by 2025.
3. Future Price Projections (2023–2027)
| Year |
Estimated Price Range (per injection) |
Rationale |
| 2023 |
$430 - $580 |
Stable with minimal inflation; potential impact from biosimilar entry |
| 2024 |
$415 - $560 |
Slight reduction if biosimilars gain market share |
| 2025 |
$400 - $540 |
Increased biosimilar competition; price erosion accelerates |
| 2026 |
$390 - $520 |
Market consolidation; payor pressure persists |
| 2027 |
$380 - $510 |
Continued erosion; stabilization expected post-biosimilar market entry |
4. Impact of Biosimilar Competition
- Biosimilars are expected to enter the market by late 2024.
- Pricing discounts of 15-25% may occur for biosimilars, influencing the originator’s pricing strategies.
5. Regulatory and Market Factors
- Expansion to additional indications could expand market size, impacting volume more than price.
- Reimbursement policies evolving toward value-based agreements could pressure prices downward.
Strategic Insights
- The stable market share combined with slow price erosion suggests sustained revenue for Janssen in the medium term.
- Entry of biosimilars will pressure prices but also expand overall utilization.
- Market volume growth in newer indications (e.g., autism) could offset some price declines.
Key Takeaways
- NDC 67877-0626 (Risperdal Consta) has a sizable and stable core market, primarily in the U.S.
- Pricing is expected to decline gradually from current levels, influenced heavily by biosimilar entry slated for 2024.
- Long-term pricing projections predict average injection prices to decrease by approximately 10-20% through 2027.
- Market expansion into new indications and regions could moderate overall revenue decline.
- Insurance and reimbursement trends favor continued access but will exert pricing pressures.
FAQs
Q1: When are biosimilars for Risperdal Consta expected to enter the market?
A1: Late 2024, based on regulatory filings and market trends.
Q2: How will biosimilar entry affect the overall market?
A2: It will likely lead to price discounts of 15-25%, reducing revenue per unit but potentially increasing overall market volume.
Q3: What are the main drivers of Risperdal Consta’s sustained market share?
A3: Efficacy, patient adherence through long-acting formulation, and established reimbursement pathways.
Q4: How does regional pricing vary?
A4: U.S. prices are higher, with European and Asian markets generally seeing lower per-injection costs due to different healthcare systems and negotiated discounts.
Q5: What are the potential opportunities for investment or R&D?
A5: Development of next-generation long-acting injectables, biosimilars, or expanded indications such as autism spectrum disorder.
References
[1] U.S. Food and Drug Administration (FDA). Risperdal Consta approval history. 2003.
[2] IQVIA. Long-acting injectable antipsychotics market report. 2022.
[3] MarketWatch. Biannual pharmaceutical pricing trends. 2022.
[4] European Medicines Agency (EMA). Risperdal Consta regulatory updates. 2022.
[5] Japan Pharmaceuticals and Medical Devices Agency. Market access reports. 2022.
