Last updated: February 15, 2026
Product Identification
NDC 00591-3540 is a pharmaceutical product marketed in the United States. Based on available databases, it corresponds to Lisdexamfetamine dimesylate capsules, used primarily for Attention Deficit Hyperactivity Disorder (ADHD) and Binge Eating Disorder (BED). It is marketed under the brand Vyvanse by Takeda Pharmaceuticals.
Market Overview
1. Current Market Size
The US stimulant medication market, primarily ADHD treatments, was valued at approximately $10.4 billion in 2022. Vyvanse accounts for roughly 20% of the stimulant segment, with annual sales near $2 billion.
2. Competitive Environment
Vyvanse faces competition from:
- Adderall XR (Shire, Allergan, and Teva)
- Concerta (J&J)
- Focalin XR (Novartis)
- Generic lisdexamfetamine formulations
Generic availability affects pricing, sales volume, and market share.
3. Regulatory Status
Vyvanse received FDA approval for ADHD in 2007, for BED in 2015, and remains a Schedule II controlled substance. Patent protection covered key formulations until 2023, with patent expirations enabling generic competition.
4. Patent and Exclusivity Timeline
- Original patent: until 2023
- Data exclusivity: until 2028 (depending on extensions)
- Generic entry anticipated post-2023
Pricing Trends
1. Brand-Name Price Point
- Average retail price for Vyvanse 30 mg capsules (per 30-count bottle): ~$300
- Insurance negotiations and discounts reduce patient out-of-pocket costs
2. Post-Patent Generic Entry
- Generics entered the market in late 2023
- Average generic lisdexamfetamine pricing: 40-60% lower than brand
- Typical wholesale acquisition cost (WAC) for generics: around $150–180 per 30-count bottle for 30 mg capsules
3. Price Trajectory
| Year |
Brand Name (Vyvanse) |
Generics (Lisdexamfetamine) |
| 2022 |
~$300 |
Not available |
| 2023 |
Patent expiry; pricing remains at ~$280–300 |
Entry occurs; ~$150–180 |
| 2024 |
Continued decline in Vyvanse sales |
Discounted prices stabilize at ~$120–180 |
Market Outlook and Price Projections
1. Short-Term (Next 1-2 Years)
- Vyvanse maintains higher prices due to brand recognition and formulary preferences
- Price erosion begins as insurance bases increasingly favor generics
- Wholesale prices for generics expected to settle at ~$120–140 for 30 mg capsules
2. Medium-Term (3-5 Years)
- Market share shift warrants further generic price reductions
- By 2026, the average price for lisdexamfetamine generics projected between $100–130
- Brand Vyvanse's market share declines to less than 20%, pressuring brand pricing and sales
3. Long-Term (Beyond 5 Years)
- Sustained generic competition could push prices downward to ~$80–100
- New formulations or delivery methods could impact market dynamics
- Price stability depends on patent litigation outcomes and regulatory decisions regarding formulations
Key Factors Influencing Price Trends
- Patent Litigation: Patent challenges could accelerate generic entry.
- Regulatory Approvals: New formulations or delivery systems might command premium prices.
- Insurance Coverage: formulary positioning and prior authorization policies influence net patient costs.
- Market Penetration: Increased use in pediatric and adult ADHD populations uplikely stabilizes or enhances sales volume, albeit at lower prices.
Summary of Pricing Drivers and Market Elements
| Drivers |
Impact |
Data Reference |
| Patent expiration |
Introduction of generics, price decrease |
[1] |
| Insurance formularies |
Shift towards generics, price pressure |
[2] |
| Regulatory developments |
New formulations/patents |
[3] |
| Market penetration |
Sales volume influence |
[4] |
Key Takeaways
- NDC 00591-3540 corresponds to Vyvanse (lisdexamfetamine dimesylate capsules).
- Market size focuses on ADHD therapy; Vyvanse holds a significant share until recent patent expiry.
- Post-patent, generics will dominate pricing, causing a decline from ~$300 to ~$80–130 over 5 years.
- The company's revenue will decrease unless new formulations or indications sustain higher prices.
FAQs
Q1: When did patent expiration occur for Vyvanse?
A1: Patent expiration was in late 2023, enabling generic entry.
Q2: What is the expected price of generic lisdexamfetamine in 2024?
A2: Approximately $120–$140 per 30-count bottle for 30 mg capsules.
Q3: How might regulatory actions affect future prices?
A3: Approvals of new formulations or patent extensions could maintain higher prices longer.
Q4: What is the main driver of price decline?
A4: Increased generic competition following patent expiration.
Q5: How will insurance policies impact net prices?
A5: Favoring generics through formulary preferences reduces out-of-pocket costs significantly.
Sources
[1] IQVIA, 2022 Pharmaceutical Market Data.
[2] SSR Health, 2022 Pricing and Market Share Analysis.
[3] FDA Patent and Exclusivity Database, 2023.
[4] EvaluatePharma, 2023 Market Forecasts.
