Last updated: February 25, 2026
What is NDC 58914-0117?
NDC 58914-0117 is a prescription drug product listed under the National Drug Code (NDC) system. It identifies a specific medication, including formulation, strength, and package size. Based on available data, this NDC corresponds to Strensiq (asfotase alfa), a treatment for hypophosphatasia.
Market Overview
Indication and Patient Population
- Indication: Hypophosphatasia (HPP), a rare metabolic disorder affecting bone mineralization.
- Prevalence: Estimated at 1 in 100,000 to 200,000 births globally; higher in specific genetic populations.
- Patient Pool: Approximately 2,000 - 4,000 patients in the U.S. based on rare disease registries (Orphanet, 2022).
Competitive Landscape
- Current Approved Therapies: Asfotase alfa (Celgene/Biogen), enzyme replacement therapy.
- Pipeline: No direct competitors approved; some experimental gene therapies in early stages.
- Pricing Pressure: Dominated by branded product with limited generic competition due to orphan designation.
Market Dynamics
Revenue Drivers
- Persistent unmet needs in severe HPP cases.
- High-cost therapy with annual treatment costs averaging $450,000—$600,000 per patient.
- Market expansion potential with increased diagnosis rates.
Market Access
- Pricing negotiated with payers based on cost-effectiveness and clinical benefits.
- Reimbursement heavily influenced by rare disease policies and orphan drug incentives.
Regulatory Environment
- Approved by FDA in 2015.
- Orphan drug status provides market exclusivity until 2025.
- Recent accelerated approvals for related indications.
Price Projections
Current Pricing
| Parameter |
Detail |
| Current Average Wholesale Price (AWP) |
$500,000 per patient per year |
| Commercial Price Range |
$450,000 - $600,000 per year |
| Patient Out-of-Pocket Cost |
$5,000 - $10,000, heavily dependent on insurance |
Future Price Trends
-
Short-term (1-3 years):
No significant price reduction expected. Reimbursement negotiations likely maintain the current price range due to limited competition and high unmet need.
-
Mid-term (3-5 years):
Patent expiry and potential introduction of biosimilars could pressure prices downward. Risks remain minimal given NDA protections and clinical complexity.
-
Long-term (5+ years):
Possible price declines of 10-20% if biosimilars gain approval and market penetration increases.
Factors Influencing Price Changes
- Biosimilar Development: Pending biosimilar competitors could disrupt pricing if market entry occurs post-2025.
- Regulatory Changes: Potential push for price controls in rare diseases, though current policies favor high prices due to small patient populations.
- Market Expansion: Broader approval for additional indications may increase sales volume without pressure on unit price.
Revenue Forecasts
| Year |
Estimated Patients |
Revenue Estimate |
Notes |
| 2023 |
2,500 |
$1.125 billion |
Based on 2,500 patients at $450,000 each |
| 2025 |
3,000 |
$1.35 billion |
Slight increase in diagnosed cases, stable price |
| 2027 |
3,500 |
$1.57 billion |
Potential biosimilar entry prompts price stabilization |
Strategic Considerations
- Innovation Incentives: Continued lightweight patent protections or additional formulations could impact pricing.
- Market Expansion: Off-label uses and increased diagnosis could raise volume, maintaining revenue even if prices decline.
- Competitive Intervention: Biosimilar approval and adoption may reduce prices, requiring monitoring of regulatory and clinical landscape.
Key Takeaways
- NDC 58914-0117 corresponds to asfotase alfa for hypophosphatasia, a rare disease with high per-patient treatment costs.
- The current market values the drug at approximately $450,000–$600,000 annually per patient.
- Limited competition sustains high prices; biosimilar entrants could threaten margins post-2025.
- Revenue forecasts remain robust, with potential for growth driven by increased diagnosis, despite potential price erosions.
FAQs
1. What factors could lead to significant price reductions for this drug?
Entry of biosimilars, regulatory price controls, and increased competition from alternative therapies could lower prices.
2. How does orphan drug status affect future pricing?
It provides market exclusivity, delaying biosimilar entry and supporting sustained high prices until 2025.
3. What is the primary driver of revenues for NDC 58914-0117?
High pricing coupled with a limited patient population results in substantial revenue per treatment year.
4. How could market expansion impact financial forecasts?
Expanding indications increase the patient pool, driving revenue even if unit prices decline.
5. Are there risks of market decline for this drug?
Yes. Biosimilar competition, policy changes, or patent challenges could reduce revenue and market share.
References
[1] Orphanet. (2022). Hypophosphatasia. Retrieved from https://www.orpha.net/consor/cgi-bin/OC_Exp.php?Lng=EN&Expert=420574
[2] U.S. Food and Drug Administration. (2015). FDA approves first therapy for rare bone disease hypophosphatasia.
[3] IQVIA. (2022). US Prescription Drug Market Trends.
[4] EvaluatePharma. (2022). Biopharma market projections.
