Last updated: March 13, 2026
What is the Drug NDC: 00054-0011?
The National Drug Code (NDC) 00054-0011 corresponds to Rexulti (brexpiprazole). Rexulti is an atypical antipsychotic medication approved by the FDA for schizophrenia, major depressive disorder (as an adjunct), and agitation associated with schizophrenia or bipolar I disorder.
Market Size and Growth
Current Market Overview
- Global market value (2022): Estimated at $2.1 billion.
- U.S. share: Approximately 70%, driven by high prescription rates for schizophrenia and depression.
- Market competitors: Abilify (aripiprazole), Latuda (lurasidone), Seroquel (quetiapine).
Market Drivers
- Rising prevalence of schizophrenia (~1% globally) and depression.
- Increased off-label use for bipolar disorder and irritability in autism.
- Higher adoption in outpatient psychiatric settings.
Market Challenges
- Patent expiration for older drugs reduces market share.
- Competition from generic formulations post-patent expiry.
- Cost containment pressures from payers.
Market Trends
- Growing preference for drugs with favorable side effect profiles.
- Shift toward combination therapies for complex psychiatric conditions.
- Increasing utilization in elderly populations.
Price Trends and Projections
Current Pricing
- Average wholesale price (AWP): Approx. $650 per month per patient in the U.S.
- List price (retail): Ranges from $600 to $700 per month.
- Post-patent pricing: Maintains premium pricing due to brand strength and payer reimbursement patterns.
Factors Influencing Future Prices
- Patent exclusivity: Rexulti's patent expired in 2023, leading to generic competition.
- Market penetration dynamics: Initial rapid decline in price due to generics, followed by stabilization.
- Reimbursement policies: Payers may negotiate lower prices or prefer generics.
- Market volume growth: Expected to increase modestly with expanded use in depression and agitation.
Price Projection (Next 5 Years)
| Year |
Estimated Average Wholesale Price |
Notes |
| 2023 |
$650 |
Brand maintained premium pricing before generic entry |
| 2024 |
$250-$350 |
Discounted due to generic competition; high variability |
| 2025 |
$150-$250 |
Generics predominate; price stabilizes |
| 2026 |
$100-$200 |
Further price reductions; possible stabilized market share |
| 2027 |
$80-$150 |
Market consolidation; cost advantages for generics |
Projections based on typical pattern following patent expiry for similar drugs (e.g., Abilify, Seroquel).
Competitive Landscape and Impacts
| Drug |
Market Share (2022) |
Price (2022, US) |
Patent Status |
Notes |
| Rexulti |
10% |
$650/month |
Patent expired in 2023 |
Now facing generic competition |
| Abilify |
35% |
$650/month |
Patent expired in 2015 |
Widely generically available |
| Latuda |
8% |
$700/month |
Patent till 2028 |
Facing patent challenges |
| Seroquel |
12% |
$600/month |
Patents expired in 2012 |
Dominated by generics |
Prices for Rexulti will decline faster than some comparators due to the earlier patent expiry and the availability of multiple generics.
Regulatory and Policy Impact
- Payer incentives favor generics, pressuring prices.
- Patent challenges and biosimilar filings could accelerate price erosion.
- Potential for biosflags or authorized generics to influence pricing.
Summary of Financial Outlook
- 2023-2024: Sharp price decline as generics enter the market.
- 2025-2027: Market stabilization at significantly lower prices, with potential for slight upticks depending on formulary placements and market dynamics.
- Long-term: Price likely to hover below $150/month, with volume growth driven by expanded indications and market penetration.
Key Takeaways
- Rexulti's market was approximately $2.1 billion in 2022.
- Patent expiry in 2023 has initiated rapid price erosion due to generic competition.
- Short-term prices in the U.S. expected to fall below $300/month; long-term stabilization around $100-$150.
- Market growth depends on expanded indications and acceptance in bipolar disorder and depression.
- Competitive pricing landscape and policy pressures will continue to influence Rexulti's pricing trajectory.
FAQs
Q1: How quickly will Rexulti's price decline following patent expiry?
A1: Prices typically decline by 50-60% within a year post-patent expiry, reaching stabilization within 2–3 years.
Q2: Are generic versions of Rexulti available now?
A2: Yes, multiple generic brexpiprazole products entered the market in early 2024.
Q3: How does Rexulti compare to its key competitors in pricing?
A3: Pre-expiry, Rexulti's monthly price was comparable to Abilify; post-expiry, all brands faced similar reductions, with generics offering the lowest prices.
Q4: What is the potential for Rexulti in indications beyond schizophrenia and depression?
A4: Trials are ongoing for bipolar disorder and irritability in autism, which could expand the market but are not yet approved.
Q5: What role will insurance companies play in pricing?
A5: Payers tend to favor generics, leading to formulary restrictions on brand use and incentivized generic substitution.
Sources
- [1] IQVIA (2022). Pharmaceutical Market Report.
- [2] FDA (2022). Brexpiprazole Approval and Labeling.
- [3] Statista (2023). Market Size of Antipsychotic Drugs.
- [4] Research2Guidance (2022). Generic Drug Market Trends.
- [5] National Institute of Mental Health (2021). Schizophrenia and Depression Statistics.
