Last updated: February 22, 2026
What is NDC 51672-1281?
NDC 51672-1281 corresponds to a specific pharmaceutical product. Based on the National Drug Code (NDC) classification, this code identifies a medication, its strength, dosage form, and manufacturer. As of current data, this NDC is associated with Vyvanse (lisdexamfetamine dimesylate), used primarily for Attention Deficit Hyperactivity Disorder (ADHD) and binge eating disorder.
Market Overview
Product Details
| Attribute |
Details |
| Drug Name |
Vyvanse |
| Manufacturer |
Takeda Pharmaceuticals |
| Remuneration |
Controlled substance Schedule II in the US |
| Formulation |
Capsule, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg |
| Indications |
ADHD, binge eating disorder |
Market Size and Trends
- U.S. Prescriptions (2022-2023): Vyvanse accounted for approximately 12 million prescriptions in 2022, a rise of 8% compared to 2021.
- Revenue Estimates: The drug brought in about $3.2 billion in 2022 (IQVIA data[1]).
- Growth Drivers: Increasing ADHD diagnosis rates, expanded treatment guidelines, and off-label use.
Competitive Landscape
| Competitors |
Key Brands |
Market Share (2022) |
Distinct Features |
| Shire (now part of Takeda) |
Adderall XR |
~25% |
Generic availability, multiple formulations |
| Johnson & Johnson |
Concerta |
~15% |
Extended-release methylphenidate |
| Novartis |
Ritalin |
~12% |
Short-acting methylphenidate |
Vyvanse dominates a niche of longer-acting stimulants, capturing approximately 20% of the stimulant market with a high-prescription rate growth.
Pricing History and Projections
Current Pricing Data
- Average Wholesale Price (AWP): The AWP for Vyvanse 30 mg capsules is approximately $370 per bottle (30 capsules), translating to ~$12.33 per capsule.
- Patient Cost Sharing: Retail pharmacy copays range from $30 to $70 per month under insurance, with cash prices around $350-$450.
Historical Price Trends (2019-2023)
| Year |
Price per Capsule |
Notes |
| 2019 |
~$11.50 |
Stable before patent exclusivity |
| 2020 |
~$12.00 |
Slight increase, market stability |
| 2021 |
~$12.20 |
Patent exclusivity maintained |
| 2022 |
~$12.33 |
Stability amid generic entry delays |
Projected Price Trajectories
- Short-Term (2024-2025): Prices expected to remain stable. The patent exclusivity in the U.S. expires in 2023, but a patent extension or litigation could delay generic entry, maintaining high prices.
- Medium-Term (2026-2028): Entry of generics anticipated. Prices could decline by 40-60%, with generic versions selling at approximately $6-$8 per capsule.
- Long-Term (2029+): Market penetration of generics will significantly reduce brand-name prices, with possible stabilization at $4-$6 per capsule.
Impact of Generic Competition
The key risk to pricing stems from generic entry. Historical data from similar drugs suggests that generic versions can capture 60-80% of market share within two years of launch, causing revenue erosion and price reductions.
Market Penetration and Pricing Strategies
Takeda's patent extensions and authorized generics could influence initial prices post-exclusivity. Strategies such as:
- Pricing Premium for Brand: Maintaining higher margins early post-patent expiry.
- Market Share Defense: Enhancing formulations or delivery methods.
- Stepping Down Prices: To deter generic entry or influence prescribing patterns.
Regulatory and Policy Impacts
- FDA Approvals: Potential new formulations or delivery systems could sustain higher prices.
- Medicaid and Medicare Policies: Price negotiation efforts might influence net revenues.
- Pricing Regulations: Legislative moves toward drug price controls may affect long-term pricing.
Summary
While Vyvanse (NDC 51672-1281) commands high prices driven by patented formulation and brand recognition, patent expiration anticipated in 2023 suggests a sharp decrease in price and market share within the next 2-3 years, aligning with typical generic competition trajectories. The current premium pricing could persist in the short term due to patent exclusivity, but a decline to $4-$6 per capsule is probable in the mid-to-long term.
Key Takeaways
- Vyvanse generates approximately $3.2 billion annually in the U.S.
- Current price per capsule (~$12.33) is stabilized by patent protection.
- Patent expiry in 2023 likely leads to generic market entry and a 40-60% price decline within 2-3 years.
- Market share will shift from branded Vyvanse to generics once approved.
- Future pricing could stabilize within $4-$6 per capsule long-term, depending on regulatory and market factors.
FAQs
Q1: When does the patent for Vyvanse (NDC 51672-1281) expire?
A: The primary patent expiration was projected for 2023, but patent extensions or litigation may extend exclusivity into 2024.
Q2: What factors influence the price of Vyvanse post-generic entry?
A: Patent status, competition intensity, formulary decisions, and regulatory policies.
Q3: How soon will generics enter the market after patent expiration?
A: Generally 6-12 months post-patent expiry, assuming patent challenges are resolved.
Q4: What impact does generic entry have on revenue streams?
A: Significant revenue decline, with market share shifting rapidly to generics, reducing prices by up to 60%.
Q5: Are there ongoing developments that could affect the market?
A: Yes. New formulations, delivery methods, or regulatory changes may influence future pricing and market dynamics.
References
- IQVIA. (2023). Pharmaceutical Market Data.
- FDA. (2023). Approved Drug Products.
- Takeda Pharmaceuticals. (2022). Vyvanse Product Information.
