Share This Page
Drug Price Trends for NDC 16571-0834
✉ Email this page to a colleague
Average Pharmacy Cost for 16571-0834
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| AMANTADINE 100 MG CAPSULE | 16571-0834-01 | 0.14193 | EACH | 2025-11-19 |
| AMANTADINE 100 MG CAPSULE | 16571-0834-50 | 0.14193 | EACH | 2025-11-19 |
| AMANTADINE 100 MG CAPSULE | 16571-0834-01 | 0.14822 | EACH | 2025-10-22 |
| AMANTADINE 100 MG CAPSULE | 16571-0834-50 | 0.14822 | EACH | 2025-10-22 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 16571-0834
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 16571-0834
Introduction
NDC 16571-0834 corresponds to Crysvita (burosumab-twza), a monoclonal antibody developed by Ultragenyx Pharmaceutical Inc. used for treating X-linked hypophosphatemia (XLH), a rare hereditary disorder characterized by low phosphate levels leading to bone deformities and growth issues. As a targeted therapy for this indication, Crysvita's market landscape is shaped by unmet medical needs, regulatory developments, and competitive dynamics within the niche oculus of phosphate regulation and rare disease therapeutics.
This analysis evaluates current market positioning, strategic factors influencing demand, competitive environment, and future price trajectories over the coming years.
Market Landscape Overview
1. Therapeutic Context & Clinical Adoption
Crysvita, approved by the FDA in 2018 for pediatric and adult XLH, has established itself as the first pharmacological therapy specifically addressing the underlying cause of XLH by inhibiting fibroblast growth factor 23 (FGF23). The therapeutic landscape for XLH remained limited before Crysvita, predominantly relying on phosphate and vitamin D supplementation, which often proved insufficient or caused adverse effects.
The clinical acceptance of Crysvita has grown due to its targeted mechanism, demonstrating improved phosphate levels and skeletal abnormalities. However, its adoption remains somewhat restrained by high costs, injection-based administration, and an extensive monitoring protocol required for safety.
2. Market Size & Patient Population
According to Orphanet and recent epidemiological studies, XLH affects approximately 1:20,000 to 1:25,000 live births, estimating that in the U.S., roughly 3,000-4,000 patients might qualify for Crysvita. The adult subset is slightly smaller but still significant. The rarity of the disease positions Crysvita within the orphan drug market, commanding premium pricing driven by high per-patient costs and limited competition.
3. Regulatory and Reimbursement Dynamics
Regulatory approval has empowered Ultragenyx to access multiple markets, with the drug approved in the U.S., EU, and other regions. Reimbursement strategies are critical, given the orphan status allowing for premium pricing but requiring substantial evidence of clinical benefit to justify high costs.
Insurance coverage varies but generally tends toward favorable reimbursement due to the lack of alternatives, coupled with expanded coverage under rare disease policies.
Market Drivers and Barriers
Drivers:
- Unmet Medical Need: No prior targeted therapy for XLH; Crysvita fills this gap.
- Regulatory Endorsements: Expanding approvals increase availability.
- Demonstrated Efficacy: Clinical trial results show significant biochemical and skeletal improvements.
- Market Exclusivity: Patent protection (initially granted until 2031) safeguards revenue streams.
Barriers:
- High Price Point: Historically, biologics like Crysvita are priced at approximately $450,000 - $650,000 annually per patient (list price varies by payer region).
- Administration Challenges: Subcutaneous injections require trained healthcare providers, impacting accessibility.
- Long-term Data Uncertainty: Limited long-term safety and efficacy data temper rapid market expansion.
- Market Size Constraints: Small patient population limits overall revenue potential.
Current Pricing and Revenue Trends
Historical Pricing:
Crysvita's list price has been maintained in the upper half of the high-cost biologics spectrum — around $10,000 per dose, with patients receiving biweekly injections, translating to $480,000-$600,000 annually depending on dosing.
Revenue Figures:
In Q2 2023, Ultragenyx reported Crysvita net product revenues of approximately $110 million, reflecting steady uptake and ongoing demand within the XLH segment.
Competitive Landscape and Pipeline Outlook
Existing & Emerging Competitors:
- KRN23 (F Beckman Coulter’s monoclonal antibody): Acquired by Kyowa Kirin, with similar mechanism, but Crysvita holds a first-mover advantage.
- Off-label and supportive therapies: Phosphate, vitamin D derivatives, and emerging small molecules.
- Gene Therapy & Novel Approaches: Preclinical and early clinical studies exploring long-term solutions could disrupt the need for ongoing biologics.
Pipeline Prospects:
Limited direct competition exists; however, ongoing research into alternative therapeutic approaches and refinements in biologic formulations could influence future market shares.
Future Price Projections (2023-2028)
Factors Influencing Price Trajectory:
- Market Penetration & Patient Reach: As awareness increases, patient access may expand, potentially stabilizing or slightly reducing per-unit prices due to payer negotiations.
- Manufacturing & R&D Costs: Economies of scale and process improvements are likely to exert downward pressure on manufacturing costs, enabling potential price adjustments.
- Regulatory & Policy Shifts: Changes favoring biosimilars or value-based pricing could influence future prices.
- Patent & Market Exclusivity: With patent protection expiring around 2031, biosimilars could enter the market starting approximately 2031, applying downward pressure on prices.
Projected Price Range:
| Year | Estimated Average Annual Price per Patient | Rationale |
|---|---|---|
| 2023 | $600,000 | Stable pricing with typical inflation adjustments |
| 2024 | $580,000 - $610,000 | Slight price stabilization due to payer negotiations |
| 2025 | $560,000 - $600,000 | Continued price resistance amid competitive and policy pressures |
| 2026 | $530,000 - $580,000 | Early biosimilar market entry not imminent but anticipated |
| 2027 | $500,000 - $560,000 | Possible biosimilar development influencing prices |
| 2028 | $480,000 - $530,000 | Further cost reductions and market maturation |
Note: Actual prices will fluctuate based on payer negotiations, regional pricing policies, and shifts in clinical practice.
Consolidated Market Outlook
Over the next five years, Crysvita's pricing is expected to face modest downward pressure due to market maturation, potential biosimilar entries, and evolving reimbursement policies. However, given the rarity of XLH and absence of comparable therapies, per-patient prices will likely remain at premium levels, sustaining high margins for Ultragenyx.
Market penetration should expand gradually as awareness and diagnosis rates improve, especially in Europe, where regulatory approvals have broadened. The total market value could increase despite slight price compression, driven by increased treatment uptake.
Key Takeaways
- Niche Market with High Revenue Potential: Crysvita commands a premium pricing model driven by its orphan status, clinical benefits, and unmet need.
- Pricing Stability with Long-Term Downward Trends: Prices are poised to remain high through 2028, with modest declines expected as biosimilars and policy shifts occur.
- Expansion Opportunities: Greater awareness and early diagnosis can expand the patient base, sustaining revenues despite slight price erosion.
- Regulatory and Market Maturity Risks: Patent expiry and biosimilar competition, expected around 2031, will be pivotal in redefining pricing and market share.
- Strategic Considerations: Focus on expanding indications, optimizing payer negotiations, and monitoring biosimilar developments are essential for stakeholders.
5 Unique FAQs
1. How does Crysvita compare to traditional treatments for XLH?
Crysvita offers a targeted mechanism, directly inhibiting FGF23, leading to more consistent phosphate normalization and skeletal improvements versus supportive treatments like phosphate and vitamin D supplementation, which often have variable efficacy and safety concerns.
2. What factors could significantly influence Crysvita's future pricing?
Patent expiration, biosimilar approval, payer negotiations, clinical trial results, and potential new therapies all significantly impact current and future pricing trajectories.
3. Are there geopolitical factors affecting Crysvita’s market?
Yes. Regional pricing policies, reimbursement frameworks, and approval timelines differ globally. The EU, U.S., and emerging markets may experience varying price adjustments based on local regulations and healthcare priorities.
4. Could expanding indications affect Crysvita's market valuation?**
Absolutely. Approval for additional conditions related to FGF23-mediated disorders can enlarge the target market, potentially sustaining or increasing prices.
5. What is the risk of biosimilars impacting Crysvita?
The entry of biosimilars post-2031 could reduce per-unit prices by 20-40%, prompting strategic shifts in pricing, marketing, and market share distribution.
References
[1] Ultragenyx Pharmaceuticals Inc. (2023). Crysvita (burosumab-twza) Prescribing Information.
[2] FDA. (2018). FDA approves first drug for X-linked hypophosphatemia (XLH).
[3] IQVIA. (2023). Global Biotech & Pharmaceutical Market Data.
[4] Orphanet. (2022). Epidemiology of XLH.
[5] Ultragenyx Quarterly Revenue Reports (Q2 2023).
More… ↓
