Last updated: February 14, 2026
Product Overview
The NDC 00527-5160 corresponds to thioguanine, an oral antimetabolite used primarily for acute myeloid leukemia (AML) and certain autoimmune conditions. Its generic status influences market dynamics and pricing.
Market Landscape
Indications and Usage
Thioguanine treats AML and other hematological malignancies, with off-label use in autoimmune diseases like vasculitis. It is often prescribed when other agents like mercaptopurine are unsuitable.
Manufacturers
Multiple generic manufacturers, including Dr. Reddy’s Laboratories, Amneal Pharmaceuticals, and Mylan, produce thioguanine. Brand manufacturers had limited or no presence due to patent expiry.
Regulatory Status
From the FDA standpoint, thioguanine is a longstanding generic drug, marketed since the 1950s. Recent concerns about safety profiles (e.g., hepatotoxicity, myelosuppression) have caused shifts in prescribing practices but have not impacted its market authorization.
Market Size & Trends
The U.S. market for thioguanine is relatively small, with estimates around $10-15 million annually, primarily driven by specialized oncology clinics and hematologists. Use has declined compared to more recent agents like azacitidine and decitabine but retains niche utility.
Pricing Factors & Competition
Generic competition has driven per-unit costs downward. As of late 2022, the average wholesale price (AWP) per 50 mg tablet ranges between $0.20 and $0.40 depending on the supplier and volume discounts. No significant recent price increases have been observed.
Price Projections
Historical Price Trends
Over the past five years, the retail price of thioguanine has steadily decreased due to generic competition, with minimal fluctuation. The core price point remains within the low dollar range per dose, reinforcing its status as an affordable chemotherapeutic agent.
Future Price Outlook (Next 3-5 Years)
Market saturation among generic manufacturers, combined with no new patents or formulations, suggests prices will stabilize or decline slightly. Factors influencing prices include:
- Manufacturing costs: Remain low given the generic nature.
- Market demand: Slight decline due to alternative agents.
- Regulatory or safety alerts: Potential to impact prescribing rates but unlikely to influence manufacturer pricing strategies.
Projected Prices
Based on current data, forecasted prices:
| Year |
Estimated Price per 50 mg tablet |
Rationale |
| 2023 |
$0.20–$0.40 |
Stable, competitive generic market |
| 2024 |
$0.18–$0.36 |
Slight decline due to ongoing generic competition |
| 2025 |
$0.15–$0.30 |
Potential plateau or further decline |
Key Factors Impacting the Market and Pricing
- Emergence of new therapies: Targeted agents with better safety profiles may reduce use.
- Regulatory concerns: Safety issues could limit prescribing, affecting volume more than price.
- Supply chain stability: No current shortages or manufacturing issues reported.
- Market consolidation: No major consolidations expected that could influence pricing.
Summary
Thioguanine (NDC 00527-5160) continues as a low-cost, low-demand drug with a stable but declining market. Prices are expected to maintain current levels or decline modestly in the ensuing years, driven by existing generic competition and shrinking clinical utilization.
Key Takeaways
- The market for thioguanine remains small, with annual sales around $10-15 million.
- Current prices range between $0.20 and $0.40 per 50 mg tablet.
- No new patents or formulations are anticipated to influence pricing.
- Market demand is under pressure from newer agents, though off-label use persists.
- The outlook suggests stable or decreasing prices over the next 3–5 years.
FAQs
1. Why has the price of thioguanine remained low?
Because it is a generic drug with multiple manufacturers, competition keeps prices competitive, and demand remains limited.
2. Are there safety concerns affecting the market?
Yes. Reports of hepatotoxicity and other adverse events have influenced prescribing patterns, potentially reducing demand.
3. Could a new formulation or patent change the market?
Unlikely. No recent patents or innovative formulations are in development for thioguanine.
4. Is thioguanine replacing newer agents?
In certain niche areas, but generally, newer, safer drugs are preferred. Its use is limited to cases where other therapies are unsuitable.
5. What are the key drivers for future price changes?
Market demand, regulatory status, and competition among generic manufacturers are primary drivers.
References
[1] IQVIA. U.S. Prescription Market Data, 2022.
[2] FDA Drug Approvals and Labeling Records, 1950s–2022.
[3] Prescriber and formulary guidelines for AML treatment.
[4] Wholesale price data from Red Book, 2022.
