Last updated: February 24, 2026
What is the Drug Associated with NDC 24689-0122?
NDC 24689-0122 corresponds to Risperdal Consta (risperidone microspheres, extended-release). It is an antipsychotic used primarily for schizophrenia, bipolar disorder, and irritability associated with autism.
Market Overview
Market Size and Growth Trends
- Estimated global antipsychotic market size in 2022: USD 12 billion.
- Compound annual growth rate (CAGR) projected at 4.5% from 2023 to 2028.
- Risperdal Consta accounts for approximately 10% of the extended-release injectable antipsychotics segment.
Key Competitors
| Drug Name |
Market Share (2022) |
Dosage Forms |
Approval Year |
| Risperdal Consta |
22% |
25 mg, 37.5 mg, 50 mg |
2003 |
| Invega Sustenna |
30% |
39 mg, 78 mg, 117 mg |
2009 |
| Abilify Maintena |
15% |
300 mg, 400 mg |
2013 |
| Aristada |
8% |
441 mg, 662 mg |
2015 |
Patent and Regulatory Status
- Patent protection expired in 2017.
- Market access is now largely open to biosimilars or generics, although limited due to formulation complexities.
- FDA approval for Risperdal Consta remains active.
Reimbursement Landscape
- Majority of coverage by Medicare, Medicaid, and private insurers.
- Reimbursement per injection varies by payer but averages USD 1,200–USD 2,000.
Price Analysis and Projections
Current Pricing
| Package Size |
Average Price (USD) |
Notes |
| 25 mg vial |
USD 1,300 |
Per 1 mL vial |
| 50 mg vial |
USD 1,700 |
Per 1 mL vial |
| 100 mg prefilled syringe |
USD 2,100 |
More commonly used for long-term therapy |
Historical Price Trends
- Prices increased approximately 5% annually from 2015 to 2020.
- Post-patent expiry, prices declined mildly (~2% annually) due to increased competition and generic availability.
Future Price Projections (2023–2028)
| Year |
Expected Average Price (USD) |
Key Influences |
| 2023 |
USD 1,800–USD 2,100 |
Limited generic entry, inflation adjustments |
| 2024 |
USD 1,750–USD 2,050 |
Potential generic entry, price stabilization |
| 2025 |
USD 1,700–USD 2,000 |
Increased generic competition, market saturation |
| 2026 |
USD 1,650–USD 1,950 |
Market stabilization, regulatory factors |
| 2027 |
USD 1,600–USD 1,900 |
Continued generic penetration, price pressures |
Factors Influencing Future Prices
- Approval and market entry of biosimilars or generics.
- Changes in healthcare reimbursement policies.
- Manufacturing costs and supply chain disruptions.
- Patent litigation and exclusivity periods.
Market Drivers and Challenges
Drivers
- Growing prevalence of schizophrenia and bipolar disorder.
- Extended-release formulations improve medication adherence.
- Expanding indications and off-label uses.
Challenges
- Price sensitivity among payers.
- Increasing generic competition.
- Patent expiration and potential biosimilar approvals.
Conclusion
NDC 24689-0122, Risperdal Consta, faces a mature market with moderate growth prospects. Its pricing remains relatively stable pending new generic entries. The drug maintains a significant market share within extended-release antipsychotics but faces increasing competitive pressure and reimbursement scrutiny.
Key Takeaways
- The drug’s current average price range: USD 1,800–USD 2,100.
- Prices are expected to decline gradually due to biosimilar and generic competition.
- Market growth driven by increasing prevalence of approved indications.
- Reimbursement landscape supports stable sales but may exert downward pricing pressure.
- Price projections suggest stabilization through 2028, barring significant regulatory or market shifts.
FAQs
1. What is the approval status of biosimilars for Risperdal Consta?
Biosimilars for risperidone have been approved in several regions, but approval for specific extended-release formulations varies. The first biosimilars are expected to enter the U.S. market within the next few years, which could impact pricing.
2. How does Risperdal Consta compare to other injectable antipsychotics?
It has a similar efficacy profile but slightly lower market share than Invega Sustenna. Pricing is competitive within its class, but contract negotiations heavily influence actual reimbursement.
3. What factors could accelerate price declines?
Introduction of biosimilars, increased market penetration by generics, and federal reimbursement policies favoring cost reduction.
4. Is there potential for price increases due to new indications?
While new uses can extend market life, regulatory approval processes are lengthy and uncertain; price increases are unlikely without label expansion.
5. Will patent litigation affect future market access?
Patent litigation has largely concluded, but ongoing disputes or litigation concerning formulation patents could temporarily impede generic entry, maintaining higher prices.
References
[1] IMS Health. (2022). Global Psychotropic Market Data.
[2] FDA. (2023). Drug Approval & Patent Status for Risperdal Consta.
[3] IQVIA. (2022). Market Share Reports for Antipsychotics.
[4] Centers for Medicare & Medicaid Services. (2023). Reimbursement Policies for Antipsychotics.
