Last updated: February 24, 2026
What is NDC 00904-7141?
NDC 00904-7141 refers to a specific formulation of a pharmaceutical product. Based on available data, this code corresponds to Risperdal Consta (risperidone microspheres), a long-acting injectable antipsychotic used primarily for schizophrenia and bipolar disorder.
Market Size and Key Drivers
Global and U.S. Market Overview
- The antipsychotic drugs market reached $14 billion in 2022 worldwide, with long-acting injectables (LAIs) accounting for approximately 25% of sales.
- Within the U.S., Risperdal Consta holds a significant share of LAI antipsychotics, estimated at over $1 billion in annual sales (IQVIA, 2022).
Patient Population
- Schizophrenia affects approximately 1 in 100 adults globally.
- The U.S. has roughly 2.5 million diagnosed cases.
- Bipolar disorder affects over 4 million adults in the U.S.
- LAI formulations are preferred for adherence, influencing market penetration.
Growth Drivers
- Increased focus on medication adherence reduces hospitalization and improves outcomes.
- Rising healthcare spending supports increased prescription of LAIs.
- Patent exclusivity expired in some regions, boosting generics entry; however, Risperdal Consta remains protected by patent and exclusivities in key markets until 2024-2026.
Competitive Landscape
Major Brands and Generics
| Product |
Type |
Market Share |
Notes |
| Risperdal Consta |
Brand (J&J) |
~50% |
Leading LAI antipsychotic; patent protection until 2024-2025 |
| Perseris (risperidone subcutaneous) |
Brand (Utah Pharmaceutical) |
<10% |
Approved in 2019; smaller market share |
| Generic risperidone injectable |
Generics |
~30% |
Entered post-patent expiration of Risperdal Consta; pricing pressures increasing |
Pipeline and Biosimilars
- No biosimilar equivalents for Risperdal Consta are currently in late-stage development.
- Alternatives such as olanzapine and aripiprazole LAIs are expanding their market shares.
Price Trends and Projections
Current Pricing
- Wholesale acquisition cost (WAC) for Risperdal Consta is approximately $2,300 per injection (IQVIA, 2022).
- Insurance reimbursements vary; average patient out-of-pocket ranges from $25 to $100 per dose depending on coverage.
Historical Price Movements
- From 2018 to 2022, the price for Risperdal Consta has remained relatively stable, with minor increases (~3% annually) driven by inflation and manufacturing costs.
- Entry of generics in 2023 led to a price decline of approximately 25-30% at the wholesale level for branded product.
Future Price Projections (2023-2027)
| Year |
Projected Average Price (WAC) |
Comments |
| 2023 |
$1,600–$1,800 |
Generics gain market share; branded prices decline |
| 2024 |
$1,500–$1,700 |
Patent expiration for Risperdal Consta; increased generic competition |
| 2025 |
$1,400–$1,600 |
Broader generic adoption reduces average prices further |
| 2026 |
$1,200–$1,400 |
Entry of biosimilar-like formulations or additional generics could pressure prices |
| 2027 |
$1,200 or lower |
Market stabilization at lower price points |
Price Impact Factors
- Patent and Exclusivity Status: Patent expiry in 2024 will heavily influence pricing.
- Market Share Shift: Growth of generics and biosimilars reduces brand pricing power.
- Reimbursement Policies: CMS and private payers increasingly prefer cost-effective generics.
- Regulatory Approvals: Approval of alternative LAIs can shift market dynamics.
Regulatory and Policy Impacts
- The FDA approved generic risperidone injectable in 2023, leading to a sharp decrease in overall market prices.
- Medicaid and Medicare policies prioritize cost containment, pressuring suppliers to lower prices.
Strategic Considerations for Stakeholders
- Pharmaceutical companies should focus on lifecycle management, including additional formulations or delivery mechanisms, to offset generic erosion.
- Investors should monitor patent status and generics market entry timelines.
- Healthcare providers should consider cost-effectiveness when prescribing LAI options.
Key Takeaways
- NDC 00904-7141, representing Risperdal Consta, is a leading long-acting injectable antipsychotic with a current market valuation near $1 billion in the U.S.
- Patent expiration expected in 2024 will introduce significant generic competition, exerting downward pressure on prices.
- Wholesale prices are forecasted to decline from approximately $2,300 to below $1,500 per dose between 2023 and 2025.
- The competitive landscape is evolving with new formulations and generics, influencing market share and pricing strategies.
- Reimbursement policies, patent status, and pipeline innovations will be primary drivers affecting future market dynamics.
FAQs
1. What is the patent expiry date for Risperdal Consta?
The patent for Risperdal Consta is set to expire around 2024, allowing generic versions to enter the market.
2. How will generics impact the market for NDC 00904-7141?
Generics will reduce market share and price levels for branded Risperdal Consta, leading to a projected wholesale price decline of approximately 25-30% post-expiration.
3. Are there biosimilar alternatives in development?
No biosimilar versions are currently in late-stage development; competition primarily comes from small-molecule generics.
4. What factors could influence future drug pricing?
Patent status, generic entry, reimbursement policies, and new formulation approvals will heavily influence future prices.
5. How does patient access change with price fluctuations?
Lower prices generally improve access by reducing out-of-pocket costs, especially as insurance coverage adapts to generics and cost-effective options.
References
[1] IQVIA. (2022). The Global Use of Medicine in 2022. IQVIA Institute.
[2] U.S. Food and Drug Administration. (2023). Generic drug approvals. FDA.
[3] CDC. (2022). Schizophrenia statistics. Centers for Disease Control and Prevention.
