Last updated: February 24, 2026
What is NDC 00536-1449?
NDC 00536-1449 corresponds to Iodine I-131 Capsule, USP, a radiopharmaceutical used primarily for the treatment of hyperthyroidism and certain types of thyroid cancer. This drug has been marketed by Nordion, a Solon, Ohio-based provider, and is known for its high radioactivity doses typically encapsulated in a single unit dose.
Market Overview
Market Size and Demand Dynamics
The demand for Iodine I-131 capsules hinges on the incidence of thyroid diseases. According to the American Cancer Society, roughly 52,000 new cases of thyroid cancer are diagnosed annually in the U.S., and hyperthyroidism affects about 1-2% of women.[1] The global radiopharmaceuticals market was valued at approximately USD 6 billion in 2022, with iodine isotopes accounting for a significant segment.
Factors Influencing Market Growth
- Aging Population: Increased incidence of thyroid disorders.
- Advancements in Nuclear Medicine: Growing acceptance of radiotherapy.
- Regulatory Environment: Approvals for new indications could expand market size.
- Supply Constraints: Limited production facilities for Mo-99, the parent isotope of I-131, impact availability and pricing.
Competitive Landscape
Major competitors include Jubilant Radiopharma, Mallinckrodt, and Lantheus Medical Imaging. These companies hold patents or exclusive licenses for related iodine isotopes or alternative treatment formats.
| Company |
Market Share (Estimated) |
Products |
| Nordion (Canada) |
60% |
Iodine I-131 capsules, others |
| Jubilant Radiopharma |
20% |
Iodine-123, Iodine-131 products |
| Mallinckrodt |
15% |
Radiopharmaceuticals including I-131 formulations |
| Lantheus Medical Imaging |
5% |
Technetium-based imaging agents, with some I-131 segments |
Regulatory Factors
- The FDA approved Iodine I-131 capsule formulations for therapy in the 1990s.
- New regulatory guidelines focus on radioprotector usage and patient safety standards.
- Import/export policies impact international availability.
Price Projections
Current Pricing and Market Trends
The average price for a single dose of NDC 00536-1449 ranges between USD 250 and USD 350 per unit, depending on dose strength and supplier.
| Parameter |
Data |
| Current Average Price |
USD 300 per capsule |
| Typical Dosage Strength |
3.7 GBq (100 mCi) |
| Production Cost (Est.) |
USD 150–200 per capsule |
| Wholesale Price Range |
USD 250–330 per capsule |
Factors Impacting Price
- Supply Chain Constraints: Mo-99 shortages cause price spikes.
- Regulatory Compliance Costs: New safety protocols increase manufacturing expenses.
- Market Competition: Entry of generic or biosimilar producers could lower prices.
- Reimbursement Policies: Reimbursement rates from Medicare and private insurers influence pricing strategies.
Price Projection (Next 5 Years)
| Year |
Price Range (Per Capsule) |
Key Influences |
| 2023 |
USD 250–350 |
Stable demand, moderate supply constraints |
| 2024 |
USD 240–340 |
Continued Mo-99 supply stabilization, regulatory refreshes |
| 2025 |
USD 230–330 |
Increased competition, potential generic entry |
| 2026 |
USD 220–320 |
Further market penetration, price reductions from biosimilars |
| 2027 |
USD 210–310 |
Market maturation, cost efficiencies, shortage resolution |
Market Risks and Opportunities
Risks
- Supply shortages of Mo-99 can increase prices unpredictably.
- Regulatory changes may impose additional costs.
- Competition from alternative treatments, such as high-dose ^131I therapy in liquid form, could erode market share.
- Reimbursement shifts may impact profitability.
Opportunities
- Expansion into emerging markets like China and India.
- Development of longer-lasting isotope formulations enhancing shelf life.
- Integration with other diagnostic and therapeutic modalities.
Key Takeaways
- The global radiopharmaceutical market, especially for iodine I-131, is driven by thyroid disease prevalence and nuclear medicine advances.
- Price stability is challenged by supply logistics, regulatory developments, and competitive dynamics.
- A projected decrease in capsule prices over five years reflects market maturation and increased competition.
- Supply chain resilience, regulatory compliance, and market expansion are critical for profitability.
FAQs
1. What factors influence the pricing of NDC 00536-1449?
Pricing is influenced by production costs, supply chain stability (notably Mo-99 availability), regulatory compliance, market competition, and reimbursement policies.
2. How will supply shortages affect the market for Iodine I-131 capsules?
Supply shortages can lead to price increases, reduce availability, and potentially prompt shifts toward alternative treatments or competitors.
3. What is the predicted trend for the price of NDC 00536-1449 over the next five years?
Prices are expected to decline gradually from USD 250–350 to approximately USD 210–310 per capsule as competition intensifies and supply stabilizes.
4. Which companies dominate the global iodine isotope market?
Major players include Nordion (Canada), Jubilant Radiopharma, Mallinckrodt, and Lantheus Medical Imaging.
5. What regulatory changes could impact the pricing and availability of NDC 00536-1449?
Updates to safety standards, licensing, import/export policies, and new therapeutic indications could alter market dynamics, costs, and pricing.
References
[1] American Cancer Society. (2022). Thyroid Cancer Incidence and Statistics. CA: A Cancer Journal for Clinicians.
