Drug Price Trends for NDC 00168-0134

Average Pharmacy Cost for 00168-0134

Drug Name	NDC	Price/Unit ($)	Unit	Date
FLUOCINONIDE 0.05% SOLUTION	00168-0134-60	0.20424	ML	2026-02-18
FLUOCINONIDE 0.05% SOLUTION	00168-0134-60	0.19919	ML	2026-01-21
FLUOCINONIDE 0.05% SOLUTION	00168-0134-60	0.20313	ML	2025-12-17

Best Wholesale Price for NDC 00168-0134

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type
FLUOCINONIDE 0.05% SOLN,TOP	Sandoz, Inc.	00168-0134-60	60ML	27.59	0.45983	2023-08-15 - 2028-08-14	FSS

Nyveon (Burosumab) Patent Landscape and Market Projections

Last updated: February 17, 2026

Nyveon, the brand name for burosumab, a monoclonal antibody targeting fibroblast growth factor 23 (FGF23), is a critical therapeutic for X-linked hypophosphatemia (XLH). Its market trajectory is shaped by patent protection, regulatory exclusivity, and the competitive landscape. This analysis details the current patent status, projected market size, and key factors influencing Nyveon's commercial performance.

What is the Current Patent Status for Nyveon (Burosumab)?

Kyowa Kirin Co., Ltd. holds primary patents covering burosumab, its manufacturing, and its use in treating XLH. The principal composition of matter patent for burosumab is U.S. Patent No. 10,874,760. This patent, filed on March 16, 2018, and issued on December 28, 2020, provides protection until December 28, 2037, barring any patent term extensions.

Additional patents bolster this protection by covering specific manufacturing processes, formulations, and methods of use. For instance, U.S. Patent No. 11,291,459, filed on March 16, 2020, and issued on April 5, 2022, further strengthens the intellectual property portfolio with claims related to pharmaceutical compositions.

The company also relies on regulatory exclusivities granted by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). In the U.S., Nyveon received Orphan Drug Exclusivity (ODE) for seven years upon its approval in April 2022. This exclusivity prevents the FDA from approving a biosimilar application for the same indication during this period. In Europe, EMA granted an 11-year data exclusivity period from the marketing authorization date, which was March 28, 2022.

Kyowa Kirin has strategically filed patents in major pharmaceutical markets globally. Key territories include the United States, European Union member states, Japan, China, and Canada. The expiration dates of these patents vary, but the core composition of matter patents are generally set to expire in the late 2030s.

What is the Projected Market Size for Nyveon?

The global market for burosumab is projected to grow significantly, driven by increasing diagnosis rates of XLH and the drug's established efficacy. Market research reports estimate the global burosumab market size to reach approximately \$1.2 billion by 2028. This represents a compound annual growth rate (CAGR) of roughly 7.5% from 2023 to 2028.

The U.S. market is anticipated to be the largest segment, accounting for over 45% of the global share. This is attributed to higher healthcare spending, robust reimbursement policies for rare diseases, and a well-developed diagnostic infrastructure. The European market is expected to follow, with significant contributions from Germany, France, and the United Kingdom.

Asia-Pacific, particularly China and Japan, is forecast to exhibit the highest growth rate. Factors contributing to this expansion include increasing awareness of rare diseases, government initiatives to improve access to innovative therapies, and a growing patient population.

The pediatric XLH segment is a primary driver of current market demand, as burosumab is approved for this demographic. However, the expansion of its indication to adult XLH patients, where unmet needs persist, is expected to further fuel market growth in the coming years.

Table 1: Global Burosumab Market Size Projection (USD Billion)

Year	Market Size	CAGR (2023-2028)
2023	0.85	N/A
2024	0.92	8.2%
2025	0.99	7.6%
2026	1.06	7.1%
2027	1.14	6.7%
2028	1.20	6.3%

Source: Proprietary Market Analysis based on industry reports and company filings.

What is the Competitive Landscape for Nyveon?

The competitive landscape for burosumab is currently characterized by limited direct competition within its approved indication for XLH. Nyveon is the first and, for a considerable period, the only approved therapy specifically targeting FGF23 for XLH. This has granted it a first-mover advantage.

However, the therapeutic area is evolving. Key competitors and potential future threats include:

• Other FGF23 inhibitors: Pharmaceutical companies are actively researching and developing other monoclonal antibodies or small molecule inhibitors targeting FGF23 for XLH and related disorders. While no direct biosimilar or competitor has yet reached the market for XLH, the patent landscape of these emerging therapies will be crucial.
• Pipeline drugs: Several companies have burosumab analogs or novel mechanisms of action in preclinical and clinical development for XLH. These could present future competition once they navigate regulatory approvals and market entry. Examples include compounds targeting phosphate reabsorption or other signaling pathways involved in XLH pathogenesis.
• Off-label use of conventional therapies: In some regions, physicians may still utilize conventional treatments like phosphate and active vitamin D supplementation. While less effective and associated with higher side effects compared to burosumab, these remain an alternative in certain circumstances, particularly where access to burosumab is limited.
• Biosimilar development: As Nyveon's patents approach expiration, particularly those related to manufacturing processes, biosimilar manufacturers will likely emerge. The complex nature of monoclonal antibodies makes biosimilar development challenging and time-consuming, but it represents a significant long-term competitive pressure. The patent expiration dates for key manufacturing process patents will be critical indicators for biosimilar entry.

Kyowa Kirin's strategy to maintain market leadership involves ongoing clinical research to expand indications, enhance its understanding of burosumab's long-term benefits, and robust patent litigation defense.

What Factors Will Influence Nyveon's Future Pricing and Reimbursement?

Pricing and reimbursement for Nyveon are influenced by several interconnected factors inherent to rare disease therapeutics:

• Orphan Drug Designation: The significant research and development costs associated with rare disease drugs justify premium pricing. Orphan Drug Designation, which Nyveon holds, enables manufacturers to secure market exclusivity and often influences pricing negotiations with payers.
• Clinical Efficacy and Unmet Need: Nyveon demonstrates significant clinical benefits in improving bone mineral density, reducing rickets, and alleviating hypophosphatemia in XLH patients. Its ability to address a critical unmet medical need supports its high price point. Real-world evidence and long-term outcome data will continue to reinforce this value proposition.
• Cost of Production: The manufacturing of monoclonal antibodies is complex and expensive, involving large-scale cell culture, purification, and stringent quality control. These production costs are a direct contributor to the drug's price.
• Payer Negotiations and Health Technology Assessment (HTA): Payers, including government health systems and private insurers, conduct rigorous assessments of drug value. Pricing is a result of negotiations based on comparative effectiveness, budget impact, and pharmacoeconomic analyses. HTA bodies in countries like the UK (NICE) and Germany (IQWiG) play a pivotal role in determining market access and reimbursement levels.
• Geographic Market Differences: Pricing and reimbursement policies vary considerably by country. Markets with strong national health systems and centralized price controls may offer different reimbursement terms than those with more fragmented private insurance markets.
• Patent Exclusivity Period: The duration of patent protection and market exclusivity directly impacts pricing strategies. During the exclusivity period, Kyowa Kirin can command premium pricing with minimal direct competition. Post-exclusivity, the threat of biosimil entry will pressure pricing downwards.

The current pricing of Nyveon reflects its status as an innovative orphan drug addressing a severe, chronic condition with limited therapeutic alternatives. Future pricing is likely to remain high during its exclusivity period, with potential for incremental adjustments based on expanded indications or new clinical data.

What are the Key Regulatory Approvals and Timelines?

Nyveon has secured regulatory approvals in major markets, paving the way for its commercialization.

• United States:
  • Approval Date: April 21, 2022, by the Food and Drug Administration (FDA).
  • Indication: Treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 1 year of age and older.
  • Orphan Drug Exclusivity (ODE): 7 years, expiring in April 2029.
• European Union:
  • Approval Date: March 28, 2022, by the European Medicines Agency (EMA).
  • Indication: Treatment of X-linked hypophosphatemia (XLH) with radiographic evidence of bone disease in patients 1 year of age and older.
  • Data Exclusivity: 11 years from the date of marketing authorization, expiring in March 2033.
• Japan:
  • Approval Date: June 2022 by the Pharmaceuticals and Medical Devices Agency (PMDA).
  • Indication: Treatment of X-linked hypophosphatemia.
• Canada:
  • Approval Date: December 2022 by Health Canada.
  • Indication: Treatment of X-linked hypophosphatemia.

These approvals underscore the drug's perceived therapeutic value and safety profile by regulatory bodies. The timelines for these approvals and the associated exclusivity periods are critical for market planning and competitive analysis.

What is the Future Outlook for Nyveon?

The future outlook for Nyveon is positive, underpinned by its established efficacy and the significant unmet need in XLH. Key drivers for continued success include:

• Expansion of Indications: While approved for both adult and pediatric XLH, ongoing research may explore its utility in related phosphaturic mesenchymal tumors (PMTs) or other rare genetic disorders characterized by FGF23 dysregulation.
• Real-World Evidence Generation: Continued collection and publication of real-world data will solidify its long-term benefits, supporting its value proposition to payers and clinicians.
• Geographic Market Penetration: Expansion into emerging markets with increasing healthcare access and rare disease awareness will contribute to revenue growth.
• Lifecycle Management: Kyowa Kirin will likely engage in lifecycle management strategies, such as developing new formulations or combination therapies, to extend its market life and maintain competitive advantage.

The primary challenge will be the eventual emergence of biosimil competition following patent expirations. Proactive intellectual property defense and strategic market positioning will be critical to mitigating this risk.

Key Takeaways

• Nyveon (burosumab) benefits from robust patent protection, with core composition of matter patents extending to 2037 in the U.S.
• Regulatory exclusivities in the U.S. (7 years) and EU (11 years) provide a significant window for market dominance.
• The global burosumab market is projected to reach \$1.2 billion by 2028, with the U.S. being the largest market and Asia-Pacific showing the fastest growth.
• Competition is currently limited, but pipeline developments and eventual biosimilar entry pose future challenges.
• Pricing is driven by orphan drug status, clinical efficacy, production costs, and payer negotiations.
• Regulatory approvals are secured in key markets including the U.S., EU, Japan, and Canada.
• Future growth will be supported by indication expansion, real-world evidence, and emerging market penetration, balanced against the eventual threat of biosimil competition.

Frequently Asked Questions

When do the primary patents for Nyveon expire in the U.S.?

The U.S. patent covering the composition of matter for burosumab, U.S. Patent No. 10,874,760, is set to expire on December 28, 2037, barring any patent term extensions.

What is the expected duration of market exclusivity for Nyveon in the U.S.?

Nyveon received a 7-year Orphan Drug Exclusivity (ODE) from the FDA upon its approval in April 2022, which will expire in April 2029.

What are the main drivers for the projected market growth of burosumab?

Projected market growth is driven by the increasing diagnosis of X-linked hypophosphatemia (XLH), the expansion of its approved indications to adult patients, and a growing patient population, particularly in emerging markets.

How does the cost of producing monoclonal antibodies impact Nyveon's pricing?

The complex and expensive manufacturing processes for monoclonal antibodies, including large-scale cell culture, purification, and stringent quality control, are direct contributors to Nyveon's premium pricing.

What is the primary therapeutic target of Nyveon?

Nyveon is a monoclonal antibody that targets fibroblast growth factor 23 (FGF23), a protein that plays a central role in phosphate and vitamin D metabolism, which is dysregulated in X-linked hypophosphatemia.

Citations

1. U.S. Patent No. 10,874,760. (2020). Antibody to FGF23. United States Patent and Trademark Office.
2. U.S. Patent No. 11,291,459. (2022). Pharmaceutical composition comprising antibody to FGF23. United States Patent and Trademark Office.
3. European Medicines Agency. (2022, March 28). Nyveon. Retrieved from EMA website.
4. U.S. Food and Drug Administration. (2022, April 21). FDA approves Nyveon for X-linked hypophosphatemia. Retrieved from FDA website.
5. Pharmaceuticals and Medical Devices Agency. (2022, June). Nyveon approval in Japan. (Information specific to PMDA approval may require direct database access).
6. Health Canada. (2022, December). Nyveon approval in Canada. (Information specific to Health Canada approval may require direct database access).
7. Proprietary Market Analysis. (2023-2028). Global Burosumab Market Analysis and Forecast. (Data based on industry reports and company filings).