Last updated: February 16, 2026
What is NDC 00904-6791?
NDC 00904-6791 is the National Drug Code designation for Vyvanse (lisdexamfetamine dimesylate). It is a central nervous system stimulant approved by the FDA primarily for treating ADHD and moderate to severe binge-eating disorder in adults.
Market Overview
Current Market Size
The stimulant medication segment in the U.S. reached approximately $5.8 billion in 2022, with Vyvanse accounting for roughly 30% of this market, equal to $1.74 billion (IQVIA, 2022). Vyvanse's market share has experienced modest growth due to increased ADHD diagnosis rates and expanding indications.
Competitive Landscape
Vyvanse faces competition from other ADHD drugs, including:
- Adderall (amphetamine salts) — over $2 billion annual sales.
- Concerta (methylphenidate) — approximately $1.5 billion annually.
- Focalin (dexmethylphenidate) — around $300 million annually.
Vyvanse advantages include a longer half-life, reduced abuse potential, and a once-daily dosing schedule.
Patent and Patent Expiry
Vyvanse’s primary patent expired in 2023, opening pathways for generic formulations. Several generics have entered the market, leading to significant price erosion and market share redistribution.
Price Trends and Projections
Historical Pricing Data
- Brand-name Vyvanse (prior to patent expiry, 2022): Average wholesale price (AWP) was circa $370 per 30-day supply.
- Post-patent expiry (2023 onward): Due to generic competition, average prices dropped approximately 50%, settling around $180–$200 per 30-day supply.
Current Pricing Dynamics
Generic versions dominate prescriptions, accounting for over 80%. Market share shifts have driven prices down, with some pharmacies offering generics for as low as $30–$50 per 30-day supply through discounts or coupon programs.
Future Price Trajectory (2023–2028)
- Short-term (1–2 years): Continued erosion of brand pricing; generic prices stabilize around $40–$60 per 30-day supply.
- Medium-term (3–5 years): Marginal price increases may occur if new formulations or delivery methods are introduced; however, ongoing patent protection for the original formulation remains unavailable.
- Long-term (5+ years): Further generic proliferation could push prices below $30 per 30-day supply, depending on market penetration and manufacturing costs.
Market Penetration and Volumes
Despite price declines, volume increases may offset revenue declines initially. Projected prescription volumes for Vyvanse are expected to grow at a compound annual growth rate (CAGR) of 3–5%, driven by rising ADHD diagnosis rates among children and adults.
Impact of Regulatory and Policy Changes
- Generic Drug Competition: Major factor in price erosion.
- Reimbursement Policies: Value-based formularies may favor lower-cost generics.
- Potential New Indications: No current FDA approvals for additional uses, limiting revenue expansion.
Strategic Implications for Stakeholders
Manufacturers: Focus on new formulations or delivery methods to sustain higher prices.
Payers: Favor generics to contain costs but may restrict access to newer or brand-name formulations.
Prescribers: Shift toward generics due to cost savings.
Patients: Benefit from lower out-of-pocket costs.
Conclusions
The market for NDC 00904-6791 (Vyvanse) has undergone significant transformation following patent expiry. Price erosion continues, with generic formulations dominating the market. Long-term revenue prospects depend on innovation and potential new indications. The volume of prescriptions remains steady or increases slightly, buffering some revenue decline from price reductions.
Key Takeaways
- Vyvanse's patent expiry triggered rapid price declines; generic versions now account for the majority of sales.
- Prices are expected to stabilize around $40–$60 per 30-day supply in the short term, with further reductions possible.
- Despite lower prices, prescription volume growth sustains revenue levels for some manufacturers.
- Market share is increasingly held by generics, with branded Vyvanse losing prominence.
- Innovation and new indications are critical for sustained revenue growth.
FAQs
1. Will Vyvanse regain market share after patent expiry?
Unlikely. Generics dominate, and recent improvements in formulations are limited. Market share shifts toward lower-cost generics.
2. How do prices of Vyvanse compare with competitors?
Generic prices are comparable to those of competing generic stimulants, often around $40–$60 per 30-day supply, significantly lower than pre-expiry brand prices.
3. Are there any upcoming regulations affecting Vyvanse prices?
Current trends suggest no imminent policies targeting Vyvanse specifically, but broader drug pricing policies may impact all CNS stimulants.
4. What is the forecast for Vyvanse prescriptions?
Prescription volumes are projected to grow modestly at 3–5% CAGR over the next five years, driven by increased ADHD diagnoses.
5. Can new formulations impact the market?
Yes. Extended-release or abuse-deterrent formulations might command higher prices, but development timelines and regulatory hurdles delay their market entry.
Sources:
[1] IQVIA, 2022. U.S. Prescription Drug Market Data.
[2] FDA, 2023. Vyvanse (lisdexamfetamine) approval and patent status.
[3] EvaluatePharma, 2023. CNS stimulant market analysis.
