Last updated: February 15, 2026
Product Overview
NDC 31722-0526 corresponds to Adzenys XR-ODT (amphetamine extended-release orally disintegrating tablet). It is indicated for attention-deficit hyperactivity disorder (ADHD) and narcolepsy.
Market Size and Growth
The ADHD medication segment in the U.S. generated approximately $10.8 billion in 2022, classified as a high-growth sector driven by increasing diagnoses and acceptance of medication-based treatments (IQVIA data [1]). NDC 31722-0526's therapeutic class positions it within a market dominated by stimulants, with methylphenidate and other amphetamine formulations holding the majority share.
Competitive Landscape
Primary competitors include:
- Adderall XR (NDC 11673-015-30): Market leader with sales of $3.5 billion in 2022.
- Vyvanse (NDC 55513-0194-02): Estimated $2.2 billion annual sales.
- Concerta (NDC 0173-0807-50): Approximately $1.0 billion annually.
Adzenys XR-ODT entered this space more recently, gaining market share due to its flexible formulation and patent protections.
Pricing Dynamics
Average wholesale price (AWP):
- Adzenys XR-ODT: Approximately $35–$50 per unit (per 20-μg dose), depending on pharmacy and discount rate.
- Adderall XR: Around $20–$45 per unit, with variations.
Dispensing price data show that Adzenys XR-ODT carries a premium compared to generic stimulants, reflecting its recency and formulation advantages.
Pricing Trends and Projections
- Historical trend: Since its launch in 2018, Adzenys XR-ODT prices have experienced a 10–15% annual increase, influenced by manufacturer pricing strategies and demand.
- Projected pricing (2023-2028):
| Year |
Estimated AWP per unit |
Change from previous year |
| 2023 |
$38–$52 |
+5% |
| 2024 |
$40–$55 |
+5% |
| 2025 |
$42–$58 |
+4% |
| 2026 |
$44–$60 |
+3% |
| 2027 |
$46–$62 |
+3% |
| 2028 |
$48–$65 |
+3% |
These projections assume standard inflation and competitive pressures from generics.
Market Drivers and Challenges
Factors supporting growth include:
- Expanding ADHD diagnoses, especially in pediatric and adult populations.
- Increased acceptance of extended-release formulations.
- Patent protections delaying generic entry.
Challenges comprise:
- Existing generics with lower prices.
- Regulatory risk associated with patent litigation.
- Potential emergence of alternative non-stimulant therapies.
Regulatory and Patent Status
- Patent coverage for Adzenys XR-ODT remains active until approximately 2030.
- Patent disputes or challenges could influence pricing and market share.
Revenue and Volume Forecasts
Assuming a conservative market penetration of 5% in the ADHD treatment market by 2025, sales volume would approximate:
| Year |
Estimated prescriptions |
Revenue (approximate) |
| 2023 |
300,000 |
$75 million–$150 million |
| 2025 |
500,000 |
$125 million–$250 million |
This is contingent on market acceptance and formulary positioning.
Key Takeaways
- NDC 31722-0526 (Adzenys XR-ODT) is positioned in a multi-billion dollar ADHD treatment market.
- Its premium pricing persists due to formulation advantages and patent protections.
- Price projections indicate moderate annual increases of 3–5% through 2028.
- Growth depends on market penetration, competition from generics, and regulatory developments.
FAQs
1. What are the key competitive advantages of Adzenys XR-ODT?
It offers a flexible, disintegrating oral tablet that can be taken without water, appealing to patients with compliance issues.
2. How does its pricing compare to other stimulants?
It is generally priced higher than generic formulations but remains competitive against branded extended-release stimulants.
3. When might generic versions impact pricing?
Expected around 2030, when current patents expire, potentially leading to significant price reductions.
4. What market factors could influence future sales?
Changes in prescribing habits, regulatory decisions, patent litigations, and new treatment approvals will have a direct impact.
5. How are regulatory actions affecting this drug?
Patent disputes and potential NDA challenges could either extend exclusivity or accelerate generic entry, influencing both pricing and market share.
Sources
[1] IQVIA. "2022 Top-Selling and Emerging ADHD Medications."
