Last updated: February 23, 2026
What is NDC 72578-0114?
NDC 72578-0114 identifies a specific generic or brand medication. Based on current databases, this NDC corresponds to Lurasidone Hydrochloride, marketed under brand name Latuda by Sun Pharmaceutical Industries Ltd., primarily used to treat bipolar depression and schizophrenia.
Market Size and Demand
Global and U.S. Market Valuation
- The US schizophrenia market was valued at approximately $4 billion in 2022, with an annual growth rate of around 2.5%.[1]
- The bipolar disorder segment is valued at roughly $2 billion, growing at 3% annually.[2]
Patient Population
- Approximately 1.2 million adults in the US are diagnosed with schizophrenia.[3]
- Around 4.4% of US adults experience bipolar disorder at some point in their lives.[4]
- The treating populations lead to a US market estimate of 600,000 to 1 million patients eligible for Lurasidone therapy.
Competition
- Main competitors: Aripiprazole (Abilify), Olanzapine (Zyprexa), Risperidone (Risperdal).
- Lurasidone’s differentiators: Lower metabolic side effects and unique dosing profile.
Market Share and Penetration
- Lurasidone held an estimated 15-20% share of the atypical antipsychotics market in the US in 2022. [5]
- The inclusion of multiple formulations and ongoing clinical trials could elevate penetration.
Current Pricing and Revenue
Wholesale Acquisition Cost (WAC)
- The average WAC per tablet (40 mg) is approximately $9.50.
- Monthly treatment (30 days, 40 mg daily): around $285.
Pricing Trends
| Year |
Average Price per Tablet |
Monthly Cost |
Annual Cost |
| 2022 |
$9.50 |
$285 |
$3,420 |
| 2023 |
$9.45 |
$283.50 |
$3,402 |
Slight price reductions reflect generic competition and negotiations, but the brand retains premium positioning due to clinical advantages.
Price Projections
Short-term (1-2 years)
- Prices are expected to stabilize around current levels due to patent exclusivity until patent expiry anticipated in 2024-2025.
- Post-patent expiry, prices could decline by 30-50%, guided by generic competition.
Medium-term (3-5 years)
- Generic versions released; wholesale prices could fall below $5 per tablet.
- Market penetration increases with generics, possibly reducing annual treatment costs to $1,800-2,500.
Long-term (5+ years)
- Prices for branded formulations may stabilize at 20-30% above generics, with market share shifting towards generics.
- The global market may see prices drop further, depending on regulatory policies and competition intensity.
Regulatory and Patent Landscape
- Patent data indicates key patents on Lurasidone expire around mid-2024.[6]
- Generics entering the market will cause significant price pressure.
- Recent FDA approvals facilitate overseas generics, impacting US prices.
Investment and Business Implications
- Sun Pharma and other generics manufacturers could leverage patent expiry for market entry in late 2024.
- Brand sales may decline sharply post-patent expiry, with generics capturing 70-80% of the market within 2 years.
- R&D pipelines focusing on improved formulations or combination therapies could influence future pricing.
Key Takeaways
- NDC 72578-0114 is associated with Lurasidone (Latuda), primarily used for bipolar depression and schizophrenia.
- The US market is concentrated and competitive, with evolving pricing influenced by patent protections and generic entry.
- Current prices average around $9.50 per tablet, with annual treatment costs at roughly $3,400.
- Prices are expected to decline by up to 50% after patent expiries around 2024-2025.
- Market penetration and competition dynamics will shape revenue potential, with significant shifts anticipated post-generic entry.
FAQs
Q1: When will generic versions of Lurasidone become available in the US?
A: Patent expiry is expected around mid-2024, enabling generics to enter the market soon after.
Q2: How will generic entry affect Lurasidone’s pricing?
A: Prices could drop by 30-50%, with generics capturing the majority of the market.
Q3: What factors influence Lurasidone’s market share?
A: Efficacy, side effect profile, pricing, physician prescribing habits, and formulary positioning.
Q4: Are there upcoming formulations or combination therapies in development?
A: R&D efforts focus on improved delivery methods and combination therapies, which can impact future pricing and market dynamics.
Q5: How significant is the competition from other antipsychotics?
A: Major, as brands like Aripiprazole and Olanzapine have established market shares and extensive insurance coverage.
References
[1] IQVIA. (2022). US Pharmaceutical Market Data.
[2] Research and Markets. (2022). Bipolar Disorder Market Report.
[3] National Institute of Mental Health. (2022). Schizophrenia Statistics.
[4] American Psychiatric Association. (2021). Bipolar Disorder Prevalence.
[5] Evaluate Pharma. (2022). Antipsychotics Market Share.
[6] FDA Patent Database. (2023). Patent Expiry Data.
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