Last updated: February 13, 2026
Overview
NDC 54738-0111 is a prescription drug product, identified by the National Drug Code (NDC) system. This specific code corresponds to Natpara (parathyroid hormone), indicated for adult and pediatric patients with hypoparathyroidism who are unable to manage their condition through calcium and activated vitamin D alone.
Market Landscape
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Patient Population: Estimated at approximately 4,000-5,000 patients in the U.S. with hypoparathyroidism, primarily post-surgical cases or idiopathic.
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Market Drivers:
- Limited treatment options for chronic hypoparathyroidism.
- Increasing awareness and diagnosis rates.
- Brand recognition and FDA approval status of Natpara (marketed by Takeda Pharmaceuticals).
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Competitive Environment:
- Few approved therapies—mainly calcium, vitamin D analogs, and off-label use of recombinant PTH (teriparatide, Forteo).
- Natpara remains the sole FDA-approved recombinant PTH therapy for this indication.
Current Pricing
- The retail list price for Natpara is approximately $63,000 per year.
- Actual reimbursed prices vary based on insurance coverage, rebates, and patient assistance programs.
Pricing Trends and Projections
| Year |
Approximate Price per Year |
Notes |
| 2023 |
$63,000 |
Base retail list price. |
| 2024 |
$62,500 – $63,000 |
Anticipated stability with potential minor reductions due to market competition and payer negotiations. |
| 2025 |
$62,000 – $62,500 |
Slight downward pressure expected as biosimilar or alternative therapies emerge. |
| 2026 |
$61,000 – $62,000 |
Continued cost management, potential reductions with increased competition. |
Cost Drivers and Potential Price Fluctuations
- Manufacturing Costs: Stable, with incremental increases for compliance and raw materials.
- Reimbursement Policies: Payers' negotiations may push prices downward.
- Market Entry of Biosimilars: As of current, no biosimilars exist; but future developments could influence prices.
- Patient Assistance Programs: Help mitigate out-of-pocket costs, impacting net revenue.
Forecast Considerations
- The high cost of Natpara aligns with its orphan drug status, manufacturing complexity, and limited competition.
- Price stability is typical in initial years post-launch unless new competitors or regulatory changes emerge.
- The introduction of biosimilars or alternative recombinant PTH therapies could reduce prices over the next five years.
Market Risks and Opportunities
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Risks:
- Regulatory delays or safety concerns could hamper sales.
- Market saturation or increased off-label use of cheaper alternatives.
- Changes in reimbursement policies affecting profitability.
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Opportunities:
- Expansion of label to pediatric patients enhances market size.
- Extension of indications for related hypoparathyroidism variants.
- Partnerships with healthcare providers to expand access.
Summary
Natpara (NDC 54738-0111) commands a high retail price with limited current competition. Market stability is projected through 2025, with potential price declines starting around 2026 due to biosimilar entry and evolving reimbursement landscapes.
Key Takeaways
- Natpara’s current annual list price is approximately $63,000.
- The patient population limits revenue but maintains high per-unit prices.
- Price projections suggest stability over the next two years, followed by gradual decreases amid increasing competition.
- Market risks include regulatory and reimbursement changes; opportunities are tied to expanded indications and market access strategies.
FAQs
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What are the primary drivers influencing Natpara's price?
Manufacturing complexity, limited competition, regulatory status, and payer negotiations.
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How likely is a biosimilar to enter the market?
Biosimilar development for recombinant PTH products is advancing, but none are approved as of 2023, making entry probable within the next 3-5 years.
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What patient access programs exist for Natpara?
Takeda offers assistance programs to reduce out-of-pocket costs, influencing net revenue metrics.
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Are there regional price variations?
Yes, prices fluctuate based on insurance coverage, geographic location, and negotiated rebates.
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How does Natpara compare to off-label treatments?
Natpara has FDA approval, making it a more consistent market staple, whereas off-label treatments are less predictable and often less effective.
Sources
[1] FDA approval documents for Natpara, 2015.
[2] IQVIA National Drug Data, 2023.
[3] Takeda Pharmaceuticals pricing and patient assistance program details.
