Last updated: February 17, 2026
Overview:
NDC 00487-0201 refers to a specific drug product registered under the National Drug Code (NDC) system. Based on available public databases, it corresponds to Dextroamphetamine Sulfate, 10 mg, a stimulant primarily used to treat Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. The drug is produced by multiple manufacturers, with formulations available in various packaging sizes.
Market Size and Usage Trends
U.S. Market Demand:
The stimulant drug class, including dextroamphetamine formulations, sees annual prescriptions exceeding 25 million units across the U.S. (IQVIA, 2022).
Estimated annual prescriptions for dextroamphetamine sulfate are around 11 million, reflecting broad usage in ADHD treatment and narcolepsy management.
Demographic Data:
The patient demographic comprises children aged 6-12 (roughly 60%) and adults (40%). The drug's usage has grown approximately 5% annually over the past five years, driven by increased ADHD diagnosis.
Market Dynamics:
- Generic competition: Several manufacturers supply dextroamphetamine sulfate, driving prices downward.
- Regulatory factors: FDA approvals and DEA scheduling restrict manufacturing and distribution, influencing supply stability.
- Insurance coverage: Most prescriptions are covered by Medicaid, Medicare, or private insurers, affecting reimbursement rates.
Competitive Landscape
Major producers include:
- Sandoz (Novartis): Generic manufacturer with high market share.
- Mylan (now part of Viatris): Key competitor in generics.
- Teva Pharmaceuticals: Also supplies generic dextroamphetamine.
- Brand equivalent: Davis's Adderall, which contains mixed amphetamine salts, is often substituted, but pure dextroamphetamine is distinctly specified.
Market share distribution is approximately:
| Manufacturer |
Share (%) |
Notable Products |
| Sandoz |
35% |
Dextroamphetamine sulfate tablets |
| Mylan/Viatris |
30% |
Generic counterparts |
| Teva |
20% |
Similar generics |
| Others |
15% |
Smaller producers |
Pricing Trends:
Average wholesale acquisition cost (WAC) for 10 mg dextroamphetamine sulfate tablets has declined from approximately $0.15 per tablet in 2018 to $0.10 per tablet in 2023 (Medicaid drug pricing reports).
Price Projections
Factors Influencing Future Prices:
-
Generic Competition:
Increased manufacturing capacity and the entry of new generic makers have sustained price erosion.
-
Regulatory Environment:
Continued DEA scheduling and manufacturing restrictions may dampen supply increases, stabilizing prices.
-
Supply Chain Dynamics:
Disruptions, such as raw material shortages or manufacturing delays, can temporarily elevate prices.
-
Market Penetration and Demand Growth:
With an estimated 5% annual increase in prescriptions, demand may slightly influence pricing.
Projected Pricing Range (Next 2-3 Years):
- Wholesale Cost: Between $0.09 – $0.11 per tablet.
- Retail Price (cash basis): Approximately $0.15 – $0.20 per tablet depending on pharmacy markups and insurance factors.
Forecast Summary:
- Prices are expected to stabilize around current levels with minor fluctuations due to supply constraints.
- Significant price increases are unlikely without policy or market shifts.
- Price differential between branded and generic versions will likely remain wide, favoring generics due to cost pressures.
Regulatory and Patent Considerations
- The patent for brand-name versions (e.g., Shire's Adderall) expired years ago, promoting the growth of generics.
- No current patent protection exists specifically for dextroamphetamine sulfate formulations, enabling multiple generics to compete.
- FDA's abbreviated new drug application (ANDA) approvals support continued generic proliferation.
Key Distinctions in Focus
| Parameter |
Data/Projection |
| Total prescriptions (2022) |
~11 million |
| Average unit price (2023) |
$0.10 – $0.15 per tablet |
| Market growth rate |
5% annually |
| Number of generic manufacturers |
4-6 major players |
| Price trend (2023-2025) |
Slight decline, stabilization at current levels |
Summary and Outlook
The market for NDC 00487-0201 (dextroamphetamine sulfate 10 mg) remains fragmented with multiple suppliers driven by high prescription volume and stable demand. Price compression continues due to competitive generic entry, with current wholesale acquisition costs around $0.10 per tablet. Price stability is expected in the mid-term, barring external disruptions or policy changes.
Key Takeaways
- Demand for dextroamphetamine sulfate remains robust, growing at 5% annually.
- Market is highly competitive with multiple generics; prices trend downward.
- Wholesale prices for 10 mg tablets are between $0.09 and $0.11.
- Future price stability hinges on supply chain constraints and regulatory policies.
- No patent barriers impede generic proliferation, sustaining competition and price pressure.
FAQs
-
How does the price of NDC 00487-0201 compare to brand-name alternatives?
Generic prices are approximately 50-70% lower than branded products like Adderall, which can cost over $0.60 per tablet.
-
Are there concerns over supply shortages?
DEA scheduling restricts manufacturing capacity, which occasionally causes temporary shortages; long-term supply stability depends on regulatory and raw material factors.
-
What is the impact of policy changes on pricing?
Increased regulation or manufacturing restrictions could constrain supply, elevating prices temporarily.
-
How does insurance coverage influence the cost for consumers?
Insurance often lowers out-of-pocket costs for patients, with actual prices varying based on copayments and formularies.
-
What are the main challenges for new market entrants?
Regulatory approval, DEA registration, and manufacturing capacity are barriers for new generic entrants.
References
- IQVIA, 2022. Prescription Drug Market Data.
- Medicaid Drug Pricing Reports, 2023.
- FDA Drug Approvals and ANDA Listings, 2023.
- Medispan Price Data, 2023.
- DEA Scheduling and Manufacturing Regulations, 2023.
[1] IQVIA. Prescription Data.
[2] Medicaid.gov. Drug pricing reports.
[3] FDA. ANDA database.
[4] Medispan. Price reports.
[5] Drug Enforcement Administration. Manufacturing and scheduling regulations.
