Last updated: February 28, 2026
What is NDC 00093-9290?
NDC 00093-9290 corresponds to a specific drug product in the National Drug Code directory. Based on references, it is identified as Gleolan (iloperidone), a medication approved for specific indications, primarily in the treatment of certain psychiatric conditions. It is marketed in capsule form.
Market Overview
Current Market Size
- The global psychiatric drug market was valued at approximately USD 21.6 billion in 2022.
- The U.S. accounted for nearly 45% of this market.
- The specific segment for atypical antipsychotics, including drugs like iloperidone, is estimated to be USD 7–9 billion annually.
Key Competitors
- Aripiprazole (Abilify): USD 4.8 billion in sales (2022)
- Lurasidone (Latuda): USD 1.8 billion
- Risperidone (Risperdal): USD 1.4 billion
- Iloperidone (Fanapt): Estimated USD 150–200 million (sales data suggest limited market penetration)
Access and Adoption
- Market penetration remains modest due to competition, side effect profiles, and clinician familiarity.
- Prescriptions have shown a slow uptick since approval, with approximately 200,000 patient prescriptions in 2022 according to IQVIA data.
Price and Revenue Data
Current Pricing
- Average wholesale price (AWP) per capsule: USD 50–60.
- Typical regimen: 1–2 capsules twice daily.
- Monthly cost per patient: USD 300–360.
Revenue Projections
| Year |
Estimated Prescriptions |
Total Revenue (USD millions) |
Notes |
| 2023 |
200,000 |
36–43 |
Based on current prescriptions |
| 2024 |
250,000 |
45–54 |
Slight growth expected |
| 2025 |
300,000 |
54–72 |
Market expansion potential |
| 2026 |
350,000 |
63–84 |
Increased adoption |
Assumptions:
- Price remains stable; no significant discounts or rebate changes.
- Prescription growth rate of 25–30% annually until saturation.
Regulatory and Market Dynamics
- FDA Status: Approved for schizophrenia; no additional indications granted.
- Market Challenges: High competition and safety profile concerns limit rapid adoption.
- Unique Advantages: May have fewer metabolic side effects compared to competitors like olanzapine.
Price Projection Factors
- Market Penetration: Up to 10% of the atypical antipsychotic market over the next five years.
- Pricing Trends: Medications tend to see 2–4% annual price increases, contingent on inflation and market dynamics.
- Rebate and Discounting Impact: Net prices could be 20–30% below wholesale, influencing actual revenue.
| Year |
Projected Average Price (USD) per Capsule |
Estimated Revenue (USD millions) |
Underlying Assumptions |
| 2023 |
55 |
36–43 |
Stable pricing, current prescription volume |
| 2024 |
57 |
45–54 |
Moderate price increase |
| 2025 |
59 |
54–72 |
Slight growth in prescriptions |
| 2026 |
61 |
63–84 |
Market expansion and price adjustments |
Risks and Opportunities
Risks
- Entrenched competition with established market share.
- Side effect profiles impacting safety perceptions.
- Potential regulatory changes or new therapeutic approvals.
Opportunities
- Expansion into emerging markets.
- Superior side effect profile to increase prescriber acceptance.
- Developing extended-release formulations.
Final Summary
NDC 00093-9290 (iloperidone) is positioned in a competitive but steadily growing segment. Current sales are limited, but with moderate prescription growth and stable pricing, revenue could approach USD 70 million by 2026. The trajectory relies heavily on market penetration, prescriber acceptance, and pricing strategies.
Key Takeaways
- The drug's current share of the market remains small, but growth prospects depend on competitive dynamics.
- Price per capsule is approximately USD 55, with annual increases of 2–3%.
- Prescriptions are expected to grow 25–30% annually until market saturation.
- Revenue projections estimate USD 45–84 million between 2024 and 2026, assuming current market trends.
- Market expansion and clinical positioning could significantly influence long-term revenue performance.
FAQs
1. Is NDC 00093-9290 approved for other indications?
No. It is approved primarily for schizophrenia; off-label uses are uncommon and unapproved.
2. What are the main competitive advantages of this drug?
It has a potentially better side effect profile, especially concerning metabolic effects, but it faces stiff competition from more established antipsychotics.
3. How sensitive are revenue projections to pricing changes?
Revenue is highly sensitive; a 5% price decrease could reduce total revenue by USD 2–3 million annually.
4. What markets beyond the U.S. could future growth come from?
Emerging markets such as China and India, where psychiatric drug markets are expanding.
5. What regulatory hurdles could impact market expansion?
Additional approvals for new indications are unlikely; however, safety concerns or adverse event reports could slow prescriber adoption.
References
[1] IQVIA. (2023). Pharmaceutical Market Data.
[2] U.S. Food and Drug Administration. (2022). Drug Approvals and Labeling.
[3] EvaluatePharma. (2022). Global pharmaceutical market forecasts.
