Last updated: February 17, 2026
What Is NDC 00173-0135?
NDC 00173-0135 is the National Drug Code for Uricase (Pegloticase), a biologic indicated for the treatment of refractory gout in adult patients. It is marketed under the brand name Krystexxa by Horizon Therapeutics.
Current Market Landscape
Market Size
- Global gout treatment market was valued at approximately $1.4 billion in 2022.
- Uricase products, including pegloticase, account for a significant share in the refractory gout segment.
- Uricase usage is limited to a niche subset of gout patients (roughly 2-4% of gout cases are refractory to standard therapies).
Key Competitors
- Krystexxa (Horizon Therapeutics)
- Experimental and off-label uricase formulations.
- Limited biosimilar options due to biological complexity.
Clinical Adoption Factors
- High cost of biologics (~$60,000 - $70,000 annually per patient).
- Need for pre-infusion testing and monitoring.
- Contraindications and concerns about infusion reactions, including anaphylaxis.
Regulatory Status
- Approved by the FDA in 2010.
- Orphan drug designation enhances market exclusivity through 2025.
- No biosimilars approved yet in the US market as of early 2023.
Price Trends and Projections
Historical Pricing
| Year |
Average Annual Price per Patient |
Notes |
| 2010 |
~$55,000 |
Market entry, initial pricing |
| 2015 |
~$65,000 |
Price increases due to inflation and demand |
| 2020 |
~$70,000 |
Further price hikes, inflation-adjusted |
Factors Influencing Future Pricing
- Limited Competition: Absence of biosimilars supports sustained high prices.
- Regulatory Exclusivity: Patent protections and orphan drug status maintain market barriers.
- Manufacturing Costs: Biologics production costs influence stable or increasing prices.
- Inflation and Healthcare Costs: Continued inflation impacts pricing strategies.
Projected Price Trajectory (2023-2028)
| Year |
Estimated Price per Patient |
Rationale |
| 2023 |
~$70,000 |
Stable, with minor increases reflecting inflation and regulatory shifts |
| 2024 |
~$72,000 |
Slight price hike anticipated, pending market and policy environment |
| 2025 |
~$75,000 |
Potential price bump near end of exclusivity, if biosimilars delay or do not launch |
| 2026 |
~$75,000 |
Price stabilization if biosimilar entry is postponed or delayed |
| 2027 |
~$77,000 |
Anticipated gradual increase influenced by inflation and manufacturing cost trends |
Market Penetration and Revenue Forecast
- Expected patient base growth: 5% annually, assuming increased awareness and diagnosis of refractory gout.
- Revenue estimates:
- 2023: ~$400 million (approximate, based on 5,700 treated patients)
- 2025: ~$620 million
- 2028: ~$880 million
Key Market Risks and Opportunities
Risks
- Biosimilar entry could erode pricing and market share.
- Regulatory changes or reimbursement restrictions impacting pricing.
- Competition from emerging therapies, such as novel oral agents or alternative biologics.
Opportunities
- Expanded indication approvals (e.g., for moderate gout in specific populations).
- Combination therapies improving efficacy and reducing infusion reactions.
- Strategic partnerships to lower manufacturing costs.
Summary
NDC 00173-0135 (Pegloticase/Krystexxa) maintains a high price point influenced by limited competition and market exclusivity. Its price is projected to stabilize around $70,000 annually per patient over the next five years, with potential increases driven by inflation, regulatory changes, and market dynamics. Price erosion is unlikely before biosimilar development materializes, which may occur post-exclusivity expiry around 2025.
Key Takeaways
- Pegloticase is a niche biologic with a high price point; it targets refractory gout patients.
- The current market is characterized by limited competition, supporting stable high pricing.
- Price projections indicate slight increases, with stabilization possible if biosimilars face delays.
- Revenue growth depends on the expansion of the refractory gout patient population.
- The entry of biosimilars remains the primary risk factor to price erosion.
FAQs
1. When will biosimilars for pegnoticase likely enter the market?
Biosimilars could enter around 2025, aligned with the expiration of patent protection and market exclusivity.
2. What are the primary barriers to biosimilar entry?
High development costs, complex manufacturing, and limited market size constrain biosimilar development for this biologic.
3. Are there other drugs competing with pegloticase?
Standard gout therapies include allopurinol and febuxostat, but these are ineffective in refractory cases where pegloticase is prescribed.
4. How does pricing compare globally?
Prices are generally lower outside the US due to different healthcare system dynamics and reimbursement models.
5. What could accelerate price declines?
Introduction of biosimilars, regulatory changes favoring biosimilar uptake, or new competitors could lead to reduced prices.
References
- IQVIA. (2022). Global Gout Treatment Market Reports.
- FDA. (2010). Approval of Krystexxa (pegloticase).
- Horizon Therapeutics. (2023). Krystexxa Prescribing Information.
- EvaluatePharma. (2022). Biologic Price Trends.
- U.S. Patent Office. (2023). Patent filings related to uricase biologics.
