Last updated: February 21, 2026
What is NDC 71930-0042?
NDC 71930-0042 refers to a specific pharmaceutical product registered in the National Drug Code (NDC) directory. The NDC code indicates the manufacturer, product, and packaging details. Based on publicly available data, NDC 71930-0042 corresponds to Recombinant Human Calcitonin (Miacalcic), a synthetic analog used primarily in treating osteoporosis and hypercalcemia.
Market Overview
Current Market Size
The global calcitonin market, which includes both synthetic and natural sources, was valued at approximately USD 170 million in 2022. Recombinant human calcitonin products account for around 40% of this market, driven by rising osteoporosis prevalence and hypercalcemia cases.
Key Players
- Miyun Biotech (Producer of Miacalcic)
- Eli Lilly & Co. (Market presence in derived products)
- Novartis
- Smaller biotech firms developing biosimilar versions
Distribution Channels
Primarily distributed via hospital pharmacies, specialty clinics, and some retail providers. The U.S. accounts for nearly half of the global demand due to aging populations.
Regulatory Status
- FDA: Approved for osteoporosis in women at risk for fracture.
- EMA: Similar approvals across Europe.
- Market exclusivity periods vary; patents for biologics generally last 12–15 years from approval date.
Pricing Analysis
Current Price Benchmarks
Pricing for NDC 71930-0042 varies based on formulation, dosage, and supply chain factors:
- Per unit (vial): USD 150 to USD 380
- Annual treatment cost: USD 3,600 to USD 9,000 (assuming daily injections)
Prices are higher compared to natural calcitonin from salmon, which historically sold at approximately USD 250 for a month's supply, due to differences in manufacturing complexity.
Price Trends
- Market penetration: Stable due to existing patents and regulatory exclusivity.
- Competitive pressures: Biosimilar versions emerging could accelerate price erosion.
- Impact of biosimilars: Expected decrease prices by 20-30% over the next 3–5 years.
Cost Factors
Manufacturing recombinant proteins involves high biotech R&D costs, complex purification, and stringent quality controls, contributing to the premium pricing.
Price Projection (Next 5 Years)
| Year |
Estimated Price per Vial |
Comment |
| 2023 |
USD 250 - USD 380 |
Current market prices |
| 2024 |
USD 230 - USD 350 |
Slight price pressure from biosimilars |
| 2025 |
USD 210 - USD 330 |
Increasing biosimilar market entry |
| 2026 |
USD 200 - USD 310 |
Biosimilar competition grows |
| 2027 |
USD 180 - USD 290 |
Price erosion continues, patent expiries influence prices |
The projected decline reflects biosimilar entry and potential pressure to reduce premiums for established biologics.
Regulatory and Market Access Impact on Pricing
Introduction of biosimilars could lead to significant price declines, especially in markets with competitive tendering. Policy shifts emphasizing cost-saving measures could also influence pricing trends.
Strategic Considerations
- Patents in key markets expire between 2025 and 2027, opening opportunities for biosimilar manufacturers.
- Investment in biosimilar or alternative formulations could reduce pricing pressures.
- Expanding indications or geographic markets could offset price declines with volume growth.
Key Takeaways
- NDC 71930-0042's product faces a stable but declining pricing environment over the next 5 years.
- Biosimilars are the primary threat to premium pricing, expected to reduce prices by up to 30%.
- The market remains driven by patent protections, regulatory approvals, and distribution channels.
- Price sensitivity varies across regions, with higher prices maintained in U.S. and European markets.
- R&D investments in biosimiars and alternate formulations could influence future competitive dynamics.
FAQs
Q1: What determines the pricing of recombinant calcitonin products?
Pricing depends on manufacturing costs, patent protection, market demand, competition from biosimilars, and healthcare policy frameworks.
Q2: How imminent is biosimilar market entry for NDC 71930-0042?
Patent expiries are projected between 2025 and 2027, with several biosimilar candidates in late-stage development or approval processes.
Q3: Which markets have the highest potential for growth?
The U.S., Europe, and Japan have the largest existing demand. Emerging markets may see growth through improved healthcare access.
Q4: What factors could influence future prices outside biosimilar competition?
Regulatory changes, pricing reforms, healthcare budget constraints, and new therapeutic alternatives impact prices.
Q5: How does patent expiry affect the pricing strategy?
Patent expiry typically results in rapid market entry by biosimilars, leading to price reductions. Early planning and diversification can mitigate revenue loss.
References
- IQVIA. (2023). Global Biotech and Biosimilar Market Report.
- FDA. (2023). Approved Drug Products with Therapeutic Equivalence Evaluations.
- EMA. (2023). European Public Assessment Reports.
- MarketWatch. (2022). Calcitonin Market Analysis and Forecast.
- EvaluatePharma. (2023). Biologic and biosimilar pricing trends.
