Last updated: February 12, 2026
Overview
NDC 51407-0169 refers to a proprietary formulation manufactured by Horizon Therapeutics. The product is an oral solution used primarily in the treatment of hyperuricemia associated with gout. It is marketed under the brand name Krystexxa (pegloticase), although the specific NDC code provided aligns with a version or presentation of this therapeutic.
Market Size and Dynamics
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Market Penetration: Krystexxa launched in 2011, with steady growth in prescribing primarily in the U.S. due to its efficacy in refractory gout cases. As of 2022, the estimated addressable market in the U.S. is approximately 900,000-1 million patients with uncontrolled gout [1].
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Key Competitors:
- Allopurinol and Febuxostat: First-line treatments, widely prescribed but less effective for refractory cases.
- Rasburicase: An alternative in certain hyperuricemia contexts.
- Emerging Biologics: Potential pipeline drugs targeting hyperuricemia and gout.
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Market Constraints:
- High treatment costs (~$70,000 annually per patient for Krystexxa).
- Intravenous administration requiring clinical visits.
- Safety concerns, including anaphylaxis risk, restrict use to specialized centers.
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Usage Trends:
- Growing awareness and approval of Krystexxa for treatment-resistant gout increase demand.
- Insurance coverage and payer policies influence access and utilization.
Price Structure and Projections
| Year |
Estimated List Price per Vial |
Estimated Treatment Course Cost |
Notes |
| 2023 |
~$49,500 |
~$150,000-$200,000 |
Current market pricing |
| 2024 |
~$50,500 |
~$153,000-$206,000 |
Based on 2-3% increase |
| 2025 |
~$51,500 |
~$156,000-$212,000 |
Continuation of trend |
| 2026 |
~$52,500 |
~$159,000-$218,000 |
Potential adjustments for market changes |
| 2027 |
~$53,500 |
~$162,000-$224,000 |
|
| 2028 |
~$54,500 |
~$165,000-$230,000 |
|
Regulatory and Policy Factors
- Pricing Reforms: U.S. policies aim to improve transparency; Medicare negotiations could influence net prices.
- Patent Life: Patent protection expected to expire in late 2029, opening opportunities for biosimilar entrants.
- Biologics Deregulation: Efforts to streamline approval could hasten biosimilar entry, intensifying price pressure.
Market Opportunities and Risks
- Increasing adoption in refractory gout patients enhances revenue potential.
- Biosimilar developments threaten to reduce prices once patent expires.
- Growing demand for outpatient therapies may favor formulations amenable to less invasive administration.
Key Takeaways
- The current market for NDC 51407-0169 centers on high-cost, specialized treatment for refractory gout.
- Prices are projected to grow modestly over the next five years, assuming no major policy shifts or biosimilar entry.
- Market growth hinges on awareness, payer coverage, and safety profile recognition.
- Patent expiration near 2029 introduces downside risk due to biosimilar competition.
- The high cost limits broad adoption but secures a sustained niche among severe cases.
FAQs
1. What is the primary therapeutic use of NDC 51407-0169?
It treats hyperuricemia in patients with gout refractory to standard therapies, marketed as Krystexxa.
2. How does the current price compare to competitors?
Krystexxa is significantly more expensive than first-line oral urate-lowering therapies like allopurinol, which costs approximately $5-10 per month.
3. What factors could influence future pricing?
Regulatory policies, biosimilar competition, market demand, and manufacturing cost changes.
4. What is the estimated market size for this drug?
Approximately 900,000 to 1 million potential patients in the U.S. with uncontrolled gout.
5. When might biosimilars enter the market?
Patent expiration around 2029, after which biosimilar competition could emerge.
Citations
[1] IQVIA National Prescription Data, 2022.