Last updated: March 10, 2026
What is the drug identified by NDC 23155-0752?
The National Drug Code (NDC) 23155-0752 refers to Lurasidone Hydrochloride tablets, 20 mg. Lurasidone is an antipsychotic medication primarily approved for the treatment of schizophrenia and bipolar depression.
What is the current market landscape for Lurasidone?
Market Size and Sales Data
- US Market Sales: The drug generated approximately $950 million in US sales in 2022, with steady growth since approval in 2010.
- Global Sales: Estimated at $1.2 billion in 2022, with North America accounting for roughly 80% of sales.
- Market Penetration: Lurasidone holds about 12% of the antipsychotic market share in the US, competing with drugs like Aripiprazole and Risperidone.
Competitive Position
- Gained FDA approval in 2010 for schizophrenia, expanded to bipolar depression in 2013.
- Benefits from a favorable side effect profile, especially lower metabolic risks compared to first-generation antipsychotics.
- Patent exclusivity expired in 2019, although certain formulations retain data exclusivity until 2024.
What is the regulatory landscape?
Patent and Exclusivity
| Precision |
Status |
Expiry/Protection Year |
| Patent |
Expired |
2019 |
| Data Exclusivity |
Data protection for original formulation |
expires 2024 |
Off-Label Use and Regulatory Changes
- No major off-label approvals.
- No pending regulatory changes that would significantly alter sales.
What are the pricing trends?
Current Pricing (2023)
| Formulation |
Average Wholesale Price (AWP) |
Estimated Patient Cost (Cash) |
| 20 mg Tablet |
$35 per tablet |
$70 per day (assuming 2 tablets) |
Price Trends
- Price has maintained stability since patent expiry, with only minor discounts due to increased generic competition.
- Generics introduced in 2019 led to a 25% price reduction.
- Insurance reimbursement rates have remained fairly consistent.
What are the projections for 2024-2028?
Factors Influencing Price and Market Growth
- Patent and Data Exclusivity: The expiration of data protections in 2024 is likely to lead to increased generic market competition.
- Generic Entry: Expected to reduce average prices by 35-50% over the next 2-3 years.
- Market Penetration: As generics gain traction, total sales volume may increase, but average price per unit will decline.
- New Indications and Off-Label Use: No major new indications are reported, limiting demand expansion.
Price Projection Summary
| Year |
Estimated Average Price per 20 mg Tablet |
Major Influencing Factors |
| 2024 |
$12-$18 |
Generic competition intensifies, data exclusivity ends |
| 2025 |
$10-$15 |
Further generics enter the market, reimbursement pressures |
| 2026 |
$8-$12 |
Continued price erosion, market saturation |
| 2027 |
$7-$11 |
Reduced brand presence, stable generics |
| 2028 |
$6-$10 |
Market stabilization at lower price points |
Market Volume and Revenue Projections
- Volume Growth: Expected to increase by 3-5% annually due to broader access and continued use in schizophrenia management.
- Revenue Decline: Total revenue could decline by 35-50% by 2028 due to price erosion, despite increased volume.
How do competitors compare?
| Drug |
Price (2023) |
Patent Status |
Market Share (2022) |
| Aripiprazole |
$20 per tablet |
Patent expired 2014 |
23% |
| Risperidone |
$5 |
Patent expired 2008 |
15% |
| Lurasidone |
$35 |
Patent expired 2019 |
12% |
Key Takeaways
- The US market for NDC 23155-0752 (Lurasidone) is mature with consistent sales, but faces pricing pressure from generic entrants.
- The end of data exclusivity in 2024 will prompt a significant price decrease, minimizing profitability for brand manufacturers.
- Market volume is expected to grow slowly, but total revenue will decline due to price erosion.
- Competitive landscape shifts toward generics, with standard pricing decreasing 30-50% over the next 2-3 years.
FAQs
1. How will generic entry affect the drug's market share?
It will likely lead to a sharp decline in the brand's market share, with generics capturing up to 80% of sales within 2 years post-2024.
2. Will price reductions impact R&D investment?
Reduced revenue from price erosion may limit R&D budgets for new formulations or indications.
3. Are there new formulations or delivery mechanisms in pipeline?
No significant new formulations are announced, and the current form remains the primary product.
4. How do reimbursement policies influence price projections?
Payor pressures favor lower reimbursement rates, contributing to price declines among generics.
5. Are alternative therapies likely to replace Lurasidone?
Other second-generation antipsychotics offer similar efficacy but may differ in side effects, influencing prescribing patterns.
References
- IQVIA. (2023). IQVIA Pharmaceuticals MarketView.
- FDA. (2019). Lurasidone Hydrochloride - Drug Approval Details.
- EvaluatePharma. (2022). Global Market Analysis for Antipsychotics.
- MedPage Today. (2022). Impact of Patent Expirations on Antipsychotic Market.
- SSR Health. (2023). Average Wholesale Price Trends.
[1] Food and Drug Administration. (2019). Lurasidone Hydrochloride Approval.
[2] IQVIA. (2023). US prescription sales report.
