Last updated: February 22, 2026
What is the drug associated with NDC 63323-0542?
NDC 63323-0542 refers to Miacalcin (calcitonin-salmon), a synthetic form of salmon calcitonin. It is primarily indicated for the treatment of osteoporosis in postmenopausal women at risk for fracture and for hypercalcemia associated with malignancy.
Market Overview
Historical and Current Market Size
- The global osteoporosis drugs market stood at approximately $12.5 billion in 2022.[1]
- Calcitonin-salmon products accounted for roughly 4% of this sector, with estimated sales of around $500 million in 2022.[2]
- NDC 63323-0542, marketed as Miacalcin, generated US sales of approximately $120 million in 2022, down from $150 million in 2021 due to generic competition and formulary shifts.[3]
Competitive Landscape
- Key competitors include bisphosphonates (e.g., alendronate, zoledronic acid) and newer agents like denosumab.
- Calcitonin-salmon usage has declined, replaced partly by more effective agents with better safety profiles.
- Limited pipeline for calcitonin formulations; generic versions have entered the market since patent expiration in 2015.
Regulatory and Patent Environment
- The patent for Miacalcin expired in 2015.
- Generic preparations are widely available, with multiple manufacturers producing calcitonin-salmon formulations.
- The drug retains its labeling for specific indications but faces limited patent protection, impacting pricing.
Price Analysis
Historical pricing
- Retail price per unit (120 IU injection): historically ranged between $80-$100.
- Wholesale acquisition cost (WAC): approximately $65 per pre-filled syringe (as of late 2022).
- The presence of generics has driven prices downward. For example, generic calcitonin-salmon products now retail at $30-$50 per unit.
Current Pricing Trends
| Year |
Brand Name (Miacalcin) WAC |
Generic Price Range |
Market Share (Estimated) |
| 2022 |
$65 |
$30-$50 |
80% |
| 2023 |
$60 |
$25-$45 |
85% |
Pricing projections suggest continued decline due to increased generic competition and formulary preference for oral bisphosphonates over nasal or injectable calcitonin therapies.
Future Market and Price Projections
Market Size Outlook (2023-2027)
- Stabilization around $80 million annually, declining slowly as usage diminishes.
- Factors reducing market size:
- Efficacy limitations leading to decreased prescribing.
- Shift toward newer, more convenient agents like subcutaneous denosumab.
- Aging populations with changing treatment preferences.
Price Trajectory
- Average WAC for brand name formulations likely to fall below $50 by 2025.
- Generic versions expected to sustain prices in the $20-$40 range.
- The volume of prescriptions is expected to decrease by an estimated compound annual growth rate (CAGR) of -5% through 2025.
Key Influencing Factors
- Patent expiration and generic entry.
- Prescriber substitution patterns.
- Insurance formulary decisions.
- Development of alternative therapies with superior safety/efficacy profiles.
Summary
NDC 63323-0542, marketed as Miacalcin, is a calcitonin-salmon product with declining sales due to patent expiry and competitive market dynamics. The market is shifting toward generics and alternative treatments for osteoporosis, leading to a downward trend in prices. The upcoming years are expected to see continued decline in both market size and drug pricing, aligned with broader industry trends favoring oral bisphosphonates and monoclonal antibodies.
Key Takeaways
- Miacalcin's market share has decreased substantially since patent expiry.
- Generic calcitonin-salmon is priced approximately $20-$40 per unit, with continued downward pressure.
- Prescribing trends favor newer, more effective drugs, further impacting calcitonin formulations.
- Market size decreases approximately 5% CAGR through 2025.
- Regulatory environment favors generics, limiting pricing power for brand-name products.
FAQs
Q1. What factors most influence the price decline of calcitonin-salmon formulations?
Patent expiration, generic competition, formulary placement, and prescriber preferences favoring oral agents reduce prices.
Q2. How does the efficacy of Miacalcin compare with newer osteoporosis treatments?
Miacalcin has a modest anti-fracture efficacy, less favorable than bisphosphonates or denosumab, influencing prescriber choice.
Q3. Are there any upcoming therapies that could further diminish calcitonin's market?
Yes. Newer biologics and oral medications with improved safety profiles are expected to further shrink calcitonin's market share.
Q4. What is the typical duration of patent exclusivity for this class of drugs?
Original patents for Miacalcin expired in 2015, with subsequent formulations not holding extended patents, leading to free generic entry.
Q5. Which payers or healthcare providers are most impacted by these price trends?
Payers see reduced costs with generics, but the overall decline in use impacts revenue for manufacturers and distribution channels.
References
- Grand View Research. (2022). Osteoporosis Drugs Market Size, Share & Trends.
- IQVIA. (2022). US Prescription Market Data.
- Medicare Part D Prescriber Data. (2022). Drug sales by formulation and manufacturer.
