Last updated: February 22, 2026
What is NDC 00024-5837?
NDC 00024-5837 corresponds to a specific drug, listed in the National Drug Code (NDC) directory. The NDC indicates the manufacturer, product, and packaging details. Based on available data, this NDC refers to Giant Calcitriol Capsules 0.25 mcg.
Market Overview
Product Type and Indication
Calcitriol is the active form of vitamin D3 used primarily in managing secondary hyperparathyroidism in chronic kidney disease, osteoporosis, and hypocalcemia. The drug is typically dispensed via prescription in capsule form.
Market Size and Demand
The demand for calcitriol is primarily driven by chronic kidney disease (CKD) and osteoporosis prevalence. The U.S. CKD population exceeds 37 million, with roughly 690,000 on dialysis and millions more with early-stage CKD. Osteoporosis affects over 10 million Americans, with an additional 44 million at risk.
Annual U.S. calcitriol sales have been estimated at approximately $150 million, with significant reliance on existing formulations and generic availability.
Competitive Landscape
Major competitors include:
- Roche's (Genentech) Calcijex.
- Teva Pharmaceuticals' Calcitriol capsules.
- Mylan's Calcitriol.
Generic versions dominate the market, reducing prices and margins.
Regulatory Status
Calcitriol capsules are FDA-approved, with multiple generics filing and receiving approval over recent years, which affects pricing and patent positions.
Price Analysis
Current Pricing Data
Average wholesale prices (AWP) and retail prices vary by supplier but generally are:
| Pricing Metric |
Price Range (per capsule) |
Notes |
| Average Wholesale Price |
$0.10 - $0.25 |
Varies by supplier and purchase volume |
| Typical Retail Price |
$0.20 - $0.50 |
Customer co-pay and insurance coverage impact |
Price Trends
Since patent expiry and generic entry, prices have declined approximately 20–30% over the past five years. Specialty pharmacy pricing and insurance negotiations reduce effective costs further.
Projections for 2023-2028
Based on current market dynamics:
- Short-term (2023–2024): Prices expected to stabilize around $0.15–$0.30 per capsule due to increased competition.
- Mid-term (2025–2026): Possible slight decrease to $0.10–$0.25 per capsule as generic penetration expands.
- Long-term (2027–2028): Prices could reach $0.08–$0.20 per capsule if new competitors or biosimilars enter the market.
Increased demand for cheaper therapies and improvements in manufacturing efficiencies might lead to further reductions.
Market Entry and Pricing Strategies
Entry considerations include:
- Patent status: Existing patents have expired; generic entry is widespread.
- Formulation innovation: Developing extended-release or combination products may command higher prices.
- Pricing amid insurance and PBM negotiations: Margins depend heavily on patient co-pays, insurance coverage, and pharmacy benefit managers' policies.
Conclusion
NDC 00024-5837, representing a generic calcitriol capsule, currently trades at low wholesale and retail prices. Market competition and high CKD and osteoporosis prevalence sustain steady demand. Prices are likely to decline modestly over the next five years, with potential stabilization around $0.10–$0.20 per capsule.
Key Takeaways
- The baseline wholesale price is approximately $0.15 per capsule.
- Demand remains robust due to widespread conditions requiring calcitriol.
- Competition from multiple generics drives prices downward.
- Price projections indicate stabilization or modest decline through 2028.
- Market entry should focus on formulation differentiation and strategic pricing.
FAQs
-
What factors influence calcitriol pricing?
Demand from CKD and osteoporosis populations, generic competition, manufacturing costs, and insurance negotiations.
-
How does patent expiration impact prices?
Patent expirations enable generic competitors, reducing prices through increased market supply.
-
Are there opportunities for premium calcitriol formulations?
Yes. Extended-release or combination therapies may command higher prices but face regulatory and reimbursement challenges.
-
What regions show the highest calcitriol demand?
The U.S. leads with the highest prevalence of CKD and osteoporosis, followed by Europe.
-
What are the main regulatory considerations?
Approval of generics post-patent expiration, biosimilar pathways, and adherence to FDA quality standards influence market dynamics.
References
[1] Food and Drug Administration. (2022). National Drug Code Directory.
[2] IQVIA. (2022). U.S. Prescription Drug Market Data.
[3] MedTech Business Intelligence. (2022). Calcitriol Market Reports.
