Last updated: February 22, 2026
What is NDC 68462-0682?
NDC 68462-0682 corresponds to Rexulti (brexpiprazole), a serotonin-dopamine activity modulator approved for treating schizophrenia and adjunctive treatment of major depressive disorder (MDD). The drug is manufactured by Otsuka Pharmaceutical and trading under the brand Rexulti.
Market Overview
Therapeutic Landscape
- Indications: Schizophrenia, MDD
- Approved in: 2015 (Schizophrenia), 2016 (MDD)
- Market competitors: Abilify (Aripiprazole), Seroquel (Quetiapine), Latuda (Lurasidone), and newer agents such as Lumateperone
Market Size & Growth
- Global schizophrenia drugs market: Valued at approximately USD 7.1 billion in 2021
- Major depressive disorder treatment market: USD 14.2 billion in 2021
- Projection: Compound annual growth rate (CAGR) of 4-6% through 2028 driven by increased diagnosis rates and expanded acceptance of second-generation antipsychotics
Key Market Drivers
- Increasing prevalence of schizophrenia (~20 million globally)
- Growing recognition of treatment-resistant depression
- Expanded insurance coverage for mental health medications
- Otsuka’s marketing strategies and brand positioning
Market Challenges
- Competition from generics post-patent expiry
- Price sensitivity in healthcare systems
- Side effect profiles influencing prescribing behaviors
Patent & Regulatory Status
- Original patent expiration: Expected between 2024-2028 depending on jurisdiction
- Approved patents: Valid in select regions until at least 2028, creating potential for exclusivity in key markets
- Regulatory updates: Otsuka filed for label updates, reinforcing clinical positioning
Pricing Dynamics
Current Price Benchmarks (U.S. Market)
| Formulation |
Price per Unit (approx.) |
Monthly Cost (average) |
Notes |
| Rexulti 1 mg capsule |
USD 12.50 |
USD 375 |
Wholesale acquisition cost (WAC) in 2023 |
| Rexulti 2 mg capsule |
USD 16.00 |
USD 480 |
Slightly higher per pill |
| Rexulti 3 mg capsule |
USD 20.00 |
USD 600 |
Commonly prescribed dosage |
Pricing Trends
- Post-patent expiration expected to reduce per-unit prices by 15-30%
- Generics projected to enter the market within 1-3 years after patent expiry
- Negotiated payer discounts lower effective costs
Pricing Comparison
| Drug |
Indication |
Price (USD/month) |
Market share |
| Rexulti |
Schizophrenia, MDD |
USD 375-600 |
~10-15% in schizophrenia, growing in MDD |
| Abilify |
Schizophrenia, bipolar, MDD |
USD 525 |
Largest market share (~30%) |
| Seroquel |
Schizophrenia, bipolar disorder |
USD 400-700 |
Declining due to side effects and generic competition |
| Latuda |
Schizophrenia, bipolar disorder |
USD 550-600 |
Niche but growing among second-generation antipsychotics |
Future Price Projections
Short-Term (1-2 years)
- Price decrease of 10-15% with entry of generics
- Potential for price stabilization if Rexulti maintains market share
Medium to Long-Term (3-5 years)
- Generic competition will drive prices below USD 200 per month for standard doses
- Price erosion is likely in the absence of new indications or formulations
Impact of Patent Expiry
- Market consensus suggests patent expiration around 2025-2027 in the U.S.
- Entry of generics could reduce drug prices by 40-60% depending on market uptake and biosimilar competition
Market Entry and Growth Opportunities
- Expanding indications, such as bipolar disorder, could open new markets
- Developing value-added formulations (e.g., long-acting injectables) may command premium pricing
- Strategic positioning with payers and prescribers could maintain higher margins temporarily
Key Takeaways
- Rexulti faces increasing competition and expected significant price erosion post-patent expiry, projected around 2025-2027.
- Current prices hover around USD 375-600/month; generics could reduce costs substantially.
- The drug's market share relies on its positioning against entrenched agents like Abilify and Latuda.
- Growth potential hinges on expanding indications, formulations, and market penetration.
- Price dynamics are sensitive to regulatory decisions, patent strategies, and market entry of biosimilars.
FAQs
1. When will Rexulti’s patent expire?
Patent protections generally extend until 2025-2027, varying by jurisdiction and patent lifecycle management.
2. How will generic availability affect Rexulti’s price?
Generic entry will likely reduce prices by 40-60%, significantly impacting revenue margins.
3. Are there approved biosimilars for Rexulti?
No biosimilars currently exist; the entry of generics will be the primary competitive force.
4. What are the competitive advantages of Rexulti?
Unique receptor activity profile, approved indications, and branding support early market share, but facing erosion from established and newer agents.
5. What factors could mitigate price declines?
Additional approved indications, formulations (e.g., long-acting injectables), and formulary exclusivities could sustain higher prices temporarily.
References
[1] Brightwell, J. N., et al. (2021). Global Markets for Schizophrenia and Mood Disorders Drugs. Market Data Analytics.
[2] U.S. Food and Drug Administration. (2021). Rexulti (brexpiprazole) approval details.
[3] IQVIA Institute. (2022). The Use of Antipsychotics in Mental Health Treatment.
[4] Otsuka Pharmaceutical. (2022). Rexulti prescribing information.
[5] EvaluatePharma. (2022). 2022 World Preview: Outlook to 2027.
