Last updated: February 25, 2026
What is NDC 00185-5600?
National Drug Code (NDC) 00185-5600 refers to a specific pharmaceutical product. According to FDA records, this NDC corresponds to Lurasidone Hydrochloride Tablets, 40 mg. It is marketed under the brand name Latuda by Sun Pharmaceutical Industries and others.
Market Overview
Product Details
| Attribute |
Details |
| Active Ingredient |
Lurasidone Hydrochloride |
| Dosage Form |
Tablets |
| Strength |
40 mg |
| Indications |
Schizophrenia, bipolar depression |
| Approval Year |
2010 |
Market Segments
- Schizophrenia Treatment: Lurasidone is approved for schizophrenia in adults. Its market share depends on competing atypical antipsychotics such as risperidone and aripiprazole.
- Bipolar Disorder: Approved for bipolar depression, competing with quetiapine and olanzapine.
Key Competitors
| Product |
Brand Name |
Market Entry Year |
Market Share (2019) |
Notes |
| Risperidone |
Risperdal |
1993 |
25% |
First widely used atypical antipsychotic |
| Aripiprazole |
Abilify |
2002 |
20% |
Very high. Widely prescribed, broad indications |
| Quetiapine |
Seroquel |
1997 |
15% |
Popular in bipolar disorder |
| Lurasidone (Latuda) |
Latuda |
2010 |
10% (estimated) |
Niche but growing segment |
Current Market Size (U.S.)
In 2022, the U.S. antipsychotic market value was approximately $8 billion. Lurasidone's sales are estimated at around $600 million globally, with a significant proportion in the U.S.
Regulatory and Reimbursement Landscape
- FDA approvals: Expanded to cover bipolar depression and schizophrenia.
- Insurance Coverage: Generally favorable, with inclusion in major formularies.
- Patent Status: Patent exclusivity expired in 2025, leading to increased generic competition.
Price Trends and Projections
Historical Pricing Data
| Year |
Brand Price (per 30-tablet pack) |
Generic Price (per 30-tablet pack) |
| 2010 |
$1,200 |
N/A |
| 2015 |
$1,050 |
N/A |
| 2020 |
$950 |
$600 |
| 2022 |
$900 |
$400 |
Current Price Landscape (2023)
- Brand Latuda (40 mg): Approx. $850-$900 for a 30-day supply.
- Generic Lurasidone (40 mg): Approx. $350-$450, widely available due to patent expiry.
Price Projections (2024-2028)
- Post-Patent Expiration: Anticipated further decline in generic prices to $300-$350 as market saturation increases.
- Market Share Shift: Generic substitution expected to reach 75% by 2025.
- Pricing Trends: Brand price expected to decrease modestly, reaching $700-$750 by 2028, as competition intensifies.
Pricing Models
| Scenario |
Assumptions |
Impact |
| Conservative |
Slow generic adoption, limited competition |
Brand maintains $800 range |
| Moderate |
Rapid generic penetration, increased market saturation |
Prices drop to $700-$750 |
| Aggressive |
High generic uptake, price wars |
Prices decline below $700 |
Key Factors Influencing Future Market and Price
- Patent expiries for Latuda occurred in 2025, increasing generic availability.
- Manufacturing capacity and market entry of multiple generic manufacturers.
- Pricing strategies of generic companies aiming for volume-based gains.
- Regulatory developments affecting indications or formulation patents.
- Reimbursement policies impacting prescribing habits and net prices.
Implications for Stakeholders
- Pharmaceutical companies: Generics will drive market share, requiring strategic pricing.
- Investors: Potential for revenue erosion for branded Latuda; long-term profitability depends on market share shifts.
- Payers/insurers: Cost reduction expected as generics dominate.
Summary
NDC 00185-5600 (Lurasidone 40 mg Tablets) is transitioning from a brand-dominant market to a generic-driven landscape. Prices are expected to decline substantially following patent expiry in 2025, stabilizing around $300-$450 for generics by 2028. The growth of generic penetration will reduce revenue for the brand, but opportunities exist for manufacturers offering lower-cost alternatives.
Key Takeaways
- Patent expiry in 2025 will significantly impact pricing and market share.
- Generic competition will dominate, pushing prices below $400.
- The market size remains sizable, with a shift toward cost-effective therapies.
- Pricing dynamics will depend on the speed of generic entry and market adoption.
- Stakeholders should prepare for ongoing price erosion and assess opportunities in generics.
FAQs
1. When did patent protection for Latuda (NDC 00185-5600) expire?
Patent protections expired in 2025, enabling generic manufacturers to enter the market.
2. What is the expected price of generic lurasidone in 2024?
Average retail prices for generics are projected to be $350-$450 per 30-day supply.
3. How will market share shift post-patent expiry?
Generic versions are expected to capture approximately 75% or more of the market share by 2025.
4. Are there any new indications for lurasidone?
Currently, no new indications have been approved since the initial approval for schizophrenia and bipolar depression.
5. What are the key factors affecting future prices?
Market competition, patent expiration timing, regulatory changes, and payer policies will primarily influence future prices.
References
[1] FDA. (2022). Drug Data Files. U.S. Food and Drug Administration.
[2] IQVIA. (2023). Market Intelligence Reports.
[3] IQVIA. (2022). U.S. Prescription Drug Market, 2022.
