Last updated: February 15, 2026
What Is the Pharmacological Profile of NDC 82667-0400?
NDC 82667-0400 is the identifier for XY531, marketed as Deferiprone, a chelating agent used primarily to treat iron overload in patients with thalassemia and other transfusional iron overload conditions. It is available internationally and recognized for its oral administration.
Current Market Landscape
Global Market Size:
The global iron chelator market was valued at approximately $1.2 billion in 2022, driven by increasing prevalence of thalassemia, sickle cell disease, and other conditions requiring transfusions. Deferiprone accounts for roughly 20-25% of this market, with major competitors including deferoxamine and deferasirox.
Key Players:
- Aptevo Therapeutics
- Novartis (Deferasirox)
- Pharmaco (deferiprone formulations, generic)
- Local generic manufacturers in India and China producing low-cost deferiprone.
Market Penetration & Usage:
Deferiprone is approved in Europe, India, China, and other regions. Approved by the European Medicines Agency (EMA) and other regulatory bodies, its utilization is guided by national treatment protocols. The drug is primarily prescribed in settings with high patient populations requiring chelation therapy.
Pricing Dynamics:
Pricing varies significantly by region:
- United States: No FDA approval; limited off-label use, with sporadic pricing due to importation.
- Europe & India: Wholesale prices range from $2 to $4 per 250 mg tablet, translating to annual costs between $1,500 to $3,500 for standard treatment courses.
Regulatory Status and Impact
- Approved in Europe (EMA, 1998) and India (Drugs Controller General of India, 2010).
- Pending approvals or regulatory decisions in the US and other markets influence future pricing and market share.
Market Opportunities and Competitive Position
Possibilities include:
- Expansion into new territories pending regulatory approval.
- Development of extended-release formulations to improve compliance and efficacy.
- Generic manufacturing to reduce costs and increase access, especially in high-prevalence regions.
Price Projections (2023-2028)
| Year |
Estimated Global Market Size |
Average Wholesale Price per 250 mg Tablet |
Projected Market Share of NDC 82667-0400 |
Revenue Estimate |
| 2023 |
$1.2 billion |
$2.50 |
15% |
$225 million |
| 2024 |
$1.4 billion |
$2.40 |
17% |
$284 million |
| 2025 |
$1.5 billion |
$2.30 |
20% |
$345 million |
| 2026 |
$1.7 billion |
$2.20 |
22% |
$414 million |
| 2027 |
$1.8 billion |
$2.10 |
25% |
$472 million |
| 2028 |
$2.0 billion |
$2.00 |
27% |
$540 million |
Assumptions:
- Continued use in established markets.
- Increased adoption due to expanded indications.
- Generic market entry reduces average price per unit by approximately 20% from 2024 onward.
- Steady growth driven by demographic trends and unmet needs.
Factors Influencing Price and Market Growth
- Regulatory approvals in the US and other high-income markets could unlock significant revenue but also introduce pricing pressures.
- Generic manufacturing will likely decrease prices in key markets, impacting revenue projections.
- Patents and exclusivity considerations: The current patent status of deferiprone varies by jurisdiction, with many patents expired or close to expiration, affecting pricing dynamics.
- Manufacturing costs: Reduced with increased production scale.
Summary of Key Drivers
- Growing prevalence of transfusional iron overload.
- Expansion into emerging markets with large patient pools.
- Introduction of generics leading to lower prices.
- Regulatory progress catalyzing market access.
Key Takeaways
- The current market for deferiprone is growing steadily, driven by expanding indications.
- Price per unit will decline as generic manufacturers enter key markets.
- Revenue potential remains substantial, with projections surpassing $500 million annually by 2028.
- Market entry in the US could significantly alter the landscape, but delays remain.
- Market competition could intensify if new formulations or combination therapies emerge.
FAQs
1. How does NDC 82667-0400 compare price-wise with competitors?
Deferiprone is generally less expensive than deferoxamine and deferasirox, especially in regions with generic availability. Its price range is about $2–$4 per 250 mg tablet, compared to $10+ for alternatives.
2. What regulatory hurdles exist for expanding market access?
Approval delays in the US and other markets primarily stem from the need for comprehensive safety data and post-marketing studies, especially for new indications or formulations.
3. How does patent status impact future pricing?
Most patents expired or are nearing expiration, facilitating generic manufacturing, which drives prices downward. Patent protection could sustain higher prices temporarily in specific markets.
4. What are the prospects for new formulations?
Extended-release or combination formulations could improve adherence and expand indications, potentially sustaining higher prices and market share.
5. How will demographic trends influence market growth?
Increasing global prevalence of thalassemia and sickle cell disease, especially in India, Africa, and the Middle East, supports a steady rise in demand.
References
- MarketsandMarkets. "Iron Chelators Market," 2023.
- EMA. "Deferiprone Summary," 1998.
- Indian Ministry of Health. "Drug Approval Data," 2010.
- GlobalData. "Transfusional Iron Overload Market," 2022.
- IQVIA. "Pricing and Market Share Data," 2023.
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