Last updated: March 26, 2026
What is NDC 81033-0027?
NDC 81033-0027 references a specific drug listed in the National Drug Code Directory. It corresponds to Lurasidone Hydrochloride, marketed under the brand name Latuda. Lurasidone is an atypical antipsychotic approved primarily for schizophrenia and bipolar disorder.
Market Size and Penetration
Current Market Landscape
- Global Market Value (2022): Estimated at $2.3 billion (Grand View Research).
- U.S. Market Share: Approximately 70% of global sales.
- Major Use Cases:
- Schizophrenia
- Bipolar depression
Key Market Drivers
- Growing prevalence of schizophrenia (~1% globally).
- Increasing bipolar disorder diagnoses (~2.4% prevalence).
- Shift toward atypical antipsychotics due to lower side-effect profiles.
Competition
| Drug Name |
Market Share |
Approval Year |
Indications |
Price (per 30-day supply) |
| Latuda (Lurasidone) |
Leading |
2010 |
Schizophrenia, bipolar depression |
$800-$900 |
| Risperdal (Risperidone) |
Significant |
1993 |
Schizophrenia, bipolar |
$70-$120 |
| Abilify (Aripiprazole) |
Significant |
2002 |
Schizophrenia, bipolar, depression |
$750-$850 |
| Saphris (Asenapine) |
Smaller |
2009 |
Schizophrenia, bipolar |
$850-$950 |
Prescriber Trends
- Increase in prescriptions correlates with approval of expanded indications.
- Growing preference for medications with favorable side-effect profiles.
Price Projections (Next 5 Years)
Factors Influencing Prices
- Patent expirations.
- Introduction of generic equivalents.
- Market competition and payer negotiations.
- Regulatory changes affecting pricing strategies.
Patent and Generic Landscape
- Patent Expiry: 2028 (expected; original patent filed in 2010).
- Generic Entry: Likely within 6–8 years post-patent expiry, with multiple manufacturers entering simultaneously.
| Year |
Estimated Average Wholesale Price (AWP) for Brand |
Projected Price for Generics |
| 2023 |
$850 |
$300–$500 |
| 2025 |
$800 |
$150–$300 |
| 2027 |
$750 |
$50–$100 |
| 2028+ |
Generic availability increases, prices decline further |
$30–$50 |
Price Trends
- Pre-Patent Expiry: Stable pricing around $800–$900.
- Post-Patent Expiry: Sharp decrease within 2 years following generic entry; prices may drop by 50–85%.
Market Entry Barriers & Opportunities
Barriers
- High development costs for new formulations.
- Regulatory hurdles.
- Payer resistance to high-cost branded drugs.
Opportunities
- Developing bioequivalent generics or biosimilars.
- Expanding indications to other psychiatric conditions.
- Offering combination therapies.
Summary
NDC 81033-0027 (Lurasidone) commands a high price due to its market position. Pending patent expiry, prices are expected to decline significantly following generic entry by 2028. The market is mature with established competitors, but opportunities exist in dosage forms and expanding indications.
Key Takeaways
- The drug is a leading atypical antipsychotic with annual sales around $2.3 billion.
- Patent expiration in 2028 will likely lead to a steep drop in prices.
- Generic entry could reduce prices to as low as $30–$50 per 30-day supply.
- Market growth remains driven by increasing prevalence of mental health conditions and clinician preference for safer profiles.
- Competition from older drugs with lower prices constrains future pricing.
FAQs
Q1: When is the patent for NDC 81033-0027 expected to expire?
A: Approximately 2028.
Q2: How will generic entry affect the drug’s price?
A: Prices are expected to drop sharply, potentially by 50–85% within two years of generic approval.
Q3: What are the main competitors for Lurasidone?
A: Risperdal (risperidone) and Abilify (aripiprazole).
Q4: Are there opportunities for new formulations to extend market life?
A: Yes, such as developing extended-release versions or combination therapies.
Q5: What is the primary regulatory risk?
A: Delays in patent expiry, patent litigation, or changes in pricing regulations could impact revenue streams.
References
- Grand View Research. (2022). Global Psychiatry Drugs Market Size, Share & Trends Analysis.
- FDA. (2010). Latuda (Lurasidone) approval letter.
- IQVIA. (2022). National Prescription Audit.
- U.S. Patent and Trademark Office. Patent status for Lurasidone.
- Thomas, C. P., et al. (2017). The future of antipsychotic drugs. Psychopharmacology.
