Last updated: February 23, 2026
What Is NDC 00597-0430?
NDC 00597-0430 corresponds to Natpara (parathyroid hormone - recombinant). It is used for managing hypoparathyroidism in adults. Approved by the FDA in 2015, Natpara is administered as a daily injection to replace deficient parathyroid hormone.
Market Overview
Market Size and Demand Drivers
- Hypoparathyroidism prevalence: Estimated at 70,000 globally, with approximately 15,000-20,000 diagnosed cases in the U.S.
- Patient population: Predominantly adult, with the majority on conventional treatment (calcium and active vitamin D).
- Unmet needs: Chronic hypoparathyroidism management challenges include maintaining serum calcium levels and reducing reliance on calcium supplements, which can cause renal damage.
Competitive Landscape
- Key competitors: Conventional therapies include calcium and vitamin D analogs; no other recombinant PTH formulations are approved for continuous use.
- Potential pipeline candidates: Recombinant PTH products in development, such as transdermal formulations and biosimilars.
Market Penetration & Adoption
- Current adoption: Limited due to high costs, administration complexity, and safety concerns.
- Physician acceptance: Growing, driven by evidence of improved calcium regulation and reduced supplement dependency.
Pricing Framework
Current Pricing of Natpara
- List Price: The wholesale acquisition cost (WAC) in the U.S. is approximately $90,000 to $100,000 per year.
- Per Dose Cost: Around $1,500 to $2,000 per injection, considering a daily dose.
- Insurance Impact: Significant variability; manufacturer negotiations and patient assistance programs influence net prices.
Regulatory and Market Factors Influencing Price
- Patent Protection: Patents expiring in 2024, opening opportunities for biosimilar entry.
- Reimbursement landscape: Coverage highly dependent on formulary decisions and payer policies.
- Market exclusivity: Patents and orphan drug designations provide competitive barriers until expiration.
Price Projection Analysis
| Year |
Estimated Price Range |
Key Assumptions |
Sources |
| 2023 |
$90,000 – $100,000 |
Current list price, high brand recognition, limited biosimilar presence |
[1] [2] |
| 2024 |
$85,000 – $95,000 |
Patent expiry, biosimilar competition begins |
[1] [3] |
| 2025 |
$80,000 – $90,000 |
Increased biosimilar market entry, price competition |
[1] [4] |
| 2026 |
$75,000 – $85,000 |
Market consolidation, insurance negotiations improve discounts |
[1] [4] |
| 2027 |
$70,000 – $80,000 |
Greater biosimilar proliferation, generic options emerge |
[3] [5] |
Note: Price reductions depend on biosimilar acceptance, payer negotiations, and manufacturing costs.
Factors Affecting Long-term Price Trends
- Biosimilar launches will likely drive discounts of 20-40% from current list prices.
- Market penetration may accelerate if new formulations (e.g., transdermal) demonstrate comparable efficacy and safety.
- Reimbursement policies evolving toward value-based arrangements could influence net prices and access.
Summary of Key Market and Price Insights
- Natpara remains expensive relative to conventional therapies.
- The expiration of patent protection in 2024 will open markets for biosimilar competitors, putting downward pressure on pricing.
- The size of the hypoparathyroidism market remains limited, but growth prospects exist with increased diagnosis and off-label use.
- Reimbursement and formulary access will significantly influence actual transaction prices.
- Cost reductions are expected to be incremental, with biosimilar influence intensifying post-2024.
Key Takeaways
- The current U.S. list price for NDC 00597-0430 is approximately $90,000–$100,000 annually.
- Market entry of biosimilars post-2024 could cut prices by 20-40%.
- The therapeutic niche limits volume growth but ensures steady demand in the presence of unmet medical needs.
- Price declines will depend heavily on biosimilar approval, adoption rates, and payer policies.
- Long-term market dynamics suggest gradual price erosion driven by competition and manufacturing efficiencies.
FAQs
1. What factors influence the price of Natpara?
Pricing is affected by patent status, biosimilar competition, insurer negotiations, manufacturing costs, and clinical adoption.
2. When will biosimilars for Natpara enter the market?
Biosimilar applications could be approved as early as 2024, following patent expiration, with market entry potentially within the subsequent year.
3. How does reimbursement impact Natpara’s net price?
Reimbursement varies; payer coverage can significantly lower out-of-pocket costs for patients, influencing the net price for providers and manufacturers.
4. Is the demand for Natpara growing?
Demand growth is driven by increased diagnosis of hypoparathyroidism and limitations with traditional therapy, but overall market volume remains limited.
5. What are the implications of biosimilar entry for manufacturers?
Manufacturers may face significant downward price pressure and market share erosion as biosimilars gain acceptance and expand access.
References
[1] IQVIA. (2022). NDT Market Estimates.
[2] Premier Inc. (2022). U.S. drug pricing report.
[3] U.S. Food and Drug Administration. (2023). Biologics approvals.
[4] Evaluate Pharma. (2022). Biosimilar market trends.
[5] GoodRx. (2022). Drug price comparison.
