Last updated: March 13, 2026
What is NDC 16571-0815?
NDC 16571-0815 is a proprietary formulation marketed as Rexulti (brexpiprazole). It is an antipsychotic approved by the FDA for schizophrenia, adjunctive treatment of major depressive disorder (MDD), and agitation associated with autism spectrum disorder (ASD).
Market Overview
Indications and Approved Uses
- Schizophrenia
- Major depressive disorder (adjunct)
- Autism spectrum disorder (agitation)
Sales Metrics and Market Share
- 2019-2022 Sales: Rexulti generated approximately $500 million annually in the U.S. (IQVIA, 2023).
- Market Penetration: It holds about 3-4% of the US antipsychotic market.
- Key Competitors:
- Abilify (aripiprazole)
- Latuda (lurasidone)
- Seroquel (quetiapine)
Pricing and Reimbursement Landscape
- Average Wholesale Price (AWP): Approximately $1,200–$1,400 for a 30-day supply.
- Medicaid Reimbursement Rate: Typically 70–80% of AWP.
- Commercial Insurance: Reimbursement varies, with copays approximately $50–$100 per month.
Market Drivers and Constraints
Drivers
- Increasing prevalence of schizophrenia and depression.
- Rising autism diagnosis rates, especially in the U.S.
- FDA approvals expand indications, growing patient population.
- Competitive pricing strategies compared to older antipsychotics.
Constraints
- Competitive pressure from generics: Abilify became generic in 2022.
- Side effect profile: Weight gain, metabolic issues.
- Prescriber familiarity with other medications.
Price Projections
Short-Term (Next 1-2 Years)
- Stable Pricing: Given market share stability and no upcoming patent expiry or significant regulatory changes.
- Expected Wholesale Price (2023-2024): Remain around $1,200–$1,400 per month per patient.
Medium-Term (3-5 Years)
- Potential Price Adjustment: Introduction of biosimilars or generics for major competitors could pressure Rexulti’s pricing.
- Projected Wholesale Price: Likely to decline 10-15%, reaching approximately $1,000–$1,200 if generic competition intensifies.
Long-Term (Beyond 5 Years)
- Market Saturation and Competition: Further lower prices likely as margins tighten with patent expirations of key competitors.
- Price Floor: Estimated around $800–$1,000 per month, depending on market dynamics and reimbursement policies.
Pricing Comparisons with Competitors
| Drug |
Indication |
2023 Wholesale Price |
Patent Status |
Notes |
| Rexulti (16571-0815) |
Schizophrenia, MDD, ASD |
$1,200–$1,400 |
Patent until ~2027 |
Market share steady |
| Abilify (aripiprazole) |
Schizophrenia, MDD, bipolar disorder |
Generic since 2022 |
Patent expired (2015) |
Price decline since generics |
| Latuda |
Schizophrenia, depressive episodes |
~$1,200 |
Patent until ~2024 |
Competitive with Rexulti |
| Seroquel |
Schizophrenia, bipolar disorder |
~$1,100 |
Patent expired (2012) |
Pricing has declined |
Key Market Trends
- Increasing adoption for off-label uses may sustain demand.
- Pricing remains sensitive to regulatory and patent challenges.
- Payers favor shorter or tiered formulary placements to control costs.
Summary
NDC 16571-0815, marketed as Rexulti, operates within a competitive antipsychotic market where sales are concentrated among branded products with some premium pricing. The drug maintains a consistent price point in the short term, with potential declines driven by generic competition anticipated over the next 3-5 years. Long-term pricing will depend heavily on patent landscape shifts and payer reimbursement policies.
Key Takeaways
- Rexulti's sales rely on stable indications, with moderate market share.
- Pricing is forecasted to decline gradually due to patent expirations and generic competition.
- Market growth prospects hinge on expanding indications and off-label use.
- Competitive landscape is aggressive, with pricing pressures from biosimilars and generics.
- Reimbursement dynamics are critical in maintaining revenue streams.
FAQs
1. When will Rexulti face generic competition?
Patent expiry is expected around 2027, after which generic brexpiprazole could enter the market.
2. How does Rexulti compare price-wise to similar drugs?
It is priced slightly higher than some generic antipsychotics but remains competitive within branded options.
3. What factors could impact Rexulti's future pricing?
Patent protection, competition from generics, regulatory changes, and reimbursement policies.
4. Is Rexulti being used off-label?
There are reports of off-label use for conditions such as Tourette’s syndrome and certain mood disorders, but these are not officially approved indications.
5. How are Medicaid and insurance companies influencing prices?
They negotiate rebates and discounts that can significantly reduce the effective price paid by payers, affecting market dynamics.
References
- IQVIA. (2023). Pharmaceutical Market Data.
- U.S. Food and Drug Administration (FDA). (2022). Drug Approvals and Labeling.
- U.S. Patent and Trademark Office. (2022). Patent Expirations.
- Wolters Kluwer. (2023). Medicaid Reimbursement Data.
- Medscape. (2023). Antipsychotic Price Trends.
