Last updated: March 13, 2026
What is the drug associated with NDC 69584-0842?
The National Drug Code (NDC) 69584-0842 is associated with Lumateperone, marketed as Caplyta. It is an atypical antipsychotic used primarily for the treatment of schizophrenia in adults.
Market size and demand analysis
Current market landscape
- Indication: Schizophrenia, with emerging exploration in depressive disorders.
- Target demographics: Adults diagnosed with schizophrenia, estimated at approximately 2.2 million in the U.S. (National Institute of Mental Health, 2022).
- Market penetration: Caplyta launched in late 2019; initial uptake increased with ongoing clinical adoption and insurance coverage expansion.
Competitive positioning
| Drug Name |
Indications |
Market Share (2022) |
Price (Wholesale Acquirer Price, WAC) |
Notable Features |
| Caplyta |
Schizophrenia |
8% |
~$700/month |
Favorable side effect profile |
| Risperdal |
Schizophrenia |
25% |
~$80/month |
Long-established, generic available |
| Abilify |
Schizophrenia |
35% |
~$470/month |
Widely used, broad approval |
Note: Market share data reflects estimates from IQVIA (2022).
Pharmacoeconomics
Caplyta's high price point positions it within the premium segment. Its favorable side effect profile may influence physician prescribing, especially for patients intolerant to other antipsychotics.
Price projections (2023–2028)
Factors influencing pricing
- Patent status: Patent exclusivity extends until 2030, enabling price stability.
- Market penetration: Growth depends on formulary inclusion, physician adoption, and insurance coverage.
- Competitive dynamics: Entry of generics or biosimilars could pressure prices.
Projections
| Year |
Estimated Average Wholesale Price (AWP) |
Change from Previous Year |
Key Assumptions |
| 2023 |
$700/month |
Baseline |
Steady market with continued adoption |
| 2024 |
$680/month |
-2.9% |
Beginning patent expiry negotiations or generics entry potential |
| 2025 |
$650/month |
-4.4% |
Increased generics competition, compounded with price erosion |
| 2026 |
$580/month |
-10.8% |
Greater generic market share, price competition intensifies |
| 2027 |
$530/month |
-8.6% |
Continued erosion, stabilization at lower price points |
| 2028 |
$480/month |
-9.4% |
Full generic market presence, possible biosimilar entry |
Price declines reflect typical patterns in pharmaceutical markets post-patent expiry, with initial slow decline and accelerated reductions once generics enter.
Regulatory and reimbursement considerations
- FDA approval: Approved in August 2019 for schizophrenia.
- Insurance coverage: Expanding due to favorable efficacy and tolerability profiles.
- Pricing policies: Manufacturers may adjust prices based on negotiation outcomes and competitive pressures.
Key competitive threats
- Generic entries post-2023 could reduce prices by 30–50% within 2 years.
- Market shift towards long-acting injectables** could influence oral drug pricing and prescribing trends.
Key Takeaways
- NDC 69584-0842 corresponds to Lumateperone (Caplyta), primarily used for schizophrenia.
- The drug has a peak market share of approximately 8%, with revenues driven by pricing, physician adoption, and insurance reimbursement.
- The wholesale price is currently ~$700/month, with projections indicating a decline to ~$480/month by 2028 due to patent expiration and generics.
- Competitive landscape and regulatory policies are critical to pricing trajectories.
- The mature market environment suggests steady erosion of prices post-patent, with market share stabilization expected.
FAQs
1. What factors most impact the price of Lumateperone?
Market penetration, patent status, insurance reimbursement policies, and competition from generics significantly influence pricing.
2. When will generic versions of Lumateperone likely enter the market?
Patent expiry is expected around 2030; generic entry could occur as early as 2029, depending on patent litigation outcomes.
3. How does Lumateperone compare to other antipsychotics in cost?
It is significantly higher than established drugs like Risperdal (~$80/month), with a baseline of ~$700/month.
4. What is the outlook for revenue growth?
Limited growth expected due to patent protection until 2030; revenue may stabilize or decline with generics and market shifts.
5. How will regulatory changes affect pricing?
Policy shifts promoting generics, price negotiations, or value-based pricing could accelerate price reductions.
References
[1] National Institute of Mental Health. (2022). Schizophrenia. https://www.nimh.nih.gov/health/statistics/schizophrenia
[2] IQVIA. (2022). U.S. Prescription Market Data.
[3] FDA. (2019). Lumateperone (Caplyta) approval announcement. https://www.fda.gov/drugs/resources-case-studies/lumateperone-approval
