KRYSTEXXA Drug Profile

Summary for Tradename: KRYSTEXXA

High Confidence Patents:	4
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for KRYSTEXXA

Recent Clinical Trials for KRYSTEXXA

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Amgen	PHASE4
M.D. Anderson Cancer Center	Phase 4
Amgen	Phase 4

See all KRYSTEXXA clinical trials

Pharmacology for KRYSTEXXA

Established Pharmacologic Class	Uric Acid-specific Enzyme
Chemical Structure	Urate Oxidase

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for KRYSTEXXA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for KRYSTEXXA Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Horizon Therapeutics Ireland Dac	KRYSTEXXA	pegloticase	Injection	125293	10,139,399	2038-02-27	DrugPatentWatch analysis and company disclosures
Horizon Therapeutics Ireland Dac	KRYSTEXXA	pegloticase	Injection	125293	12,188,927	2044-04-09	DrugPatentWatch analysis and company disclosures
Horizon Therapeutics Ireland Dac	KRYSTEXXA	pegloticase	Injection	125293	6,783,965	2020-02-10	DrugPatentWatch analysis and company disclosures
Horizon Therapeutics Ireland Dac	KRYSTEXXA	pegloticase	Injection	125293	9,885,024	2035-07-22	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for KRYSTEXXA Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Horizon Therapeutics Ireland Dac	KRYSTEXXA	pegloticase	Injection	125293	10,668,053	2034-05-02	Patent claims search

International Patents for KRYSTEXXA

Country	Patent Number	Estimated Expiration
Japan	5341945
European Patent Office	2446260
Germany	69943205
Hong Kong	1141738
Australia	2001249975
Mexico	PA02007545
Australia	2006203252

Supplementary Protection Certificates for KRYSTEXXA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
132013902172095	Italy		PRODUCT NAME: PEGLOTICASI E OGNI SUA FORMA TERAPEUTICAMENTE EQUIVALENTE COME PROTETTA DAL BREVETTO BASE(KRYSTEXXA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/12/810, 20130108
SPC/GB13/039	United Kingdom		PRODUCT NAME: PEGLOTICASE; REGISTERED: UK EU/1/12/810 20130108
CA 2013 00038	Denmark		PRODUCT NAME: PEGLOTICASE OG ENHVER TERAPEUTISK AEKVIVALENT FORM DERAF SOM ER OMFATTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/12/810 20130108
13C0036	France		PRODUCT NAME: PEGLOTICASE; REGISTRATION NO/DATE: EU/1/12/810 20130108
41/2013	Austria		PRODUCT NAME: PEGLOTICASE; NAT. REGISTRATION NO/DATE: EU/1/12/810 20130108; FIRST REGISTRATION: EU EU/1/2/810 20130108
2013/029	Ireland		PRODUCT NAME: PEGLOTICASE; NAT REGISTRATION NO/DATE: EU/1/12/810 20130108; FIRST REGISTRATION NO/DATE: EU/1/12/810 20130108
1390031-1	Sweden		PRODUCT NAME: PEGLOTIKAS; REG. NO/DATE: EU/1/12/810 20130108

Market Dynamics and Financial Trajectory for the Biologic Drug: KRYSTEXXA

Last updated: September 26, 2025

Introduction

KRYSTEXXA (pegloticase) has established itself as a critical biologic therapy targeting refractory gout, a chronic and debilitating condition compounded by uric acid crystal accumulation. Approved by the FDA in 2010, KRYSTEXXA functions as a pegylated recombinant uricase, catalyzing the conversion of uric acid into allantoin, a more soluble and easily excreted compound. Its unique mechanism has positioned it within a niche, delivering significant therapeutic benefits for patients unresponsive to conventional treatments. Yet, the overall market dynamics and financial trajectory of KRYSTEXXA are shaped by intricate factors, including clinical efficacy, competitive landscape, regulatory environment, and market access challenges.

Market Landscape and Demand Drivers

Prevalence and Patient Population

Gout affects approximately 4% of adults globally, with certain regions reporting higher prevalence rates—up to 8-10% in some states within the U.S. (Centers for Disease Control and Prevention). Refractory gout, characterized by persistent hyperuricemia despite traditional urate-lowering therapy, accounts for a smaller but significant subset estimated at around 10-20% of gout patients (Roddy et al., 2012). These patients, often intolerant to standard agents or with rapid disease progression, constitute the primary target demographic for KRYSTEXXA.

Clinical Need and Unmet Medical Need

While drugs like allopurinol and febuxostat serve as first-line therapies, a subset exhibits inadequate response or adverse reactions, necessitating alternative solutions. KRYSTEXXA provides a targeted biologic option, demonstrating high efficacy in reducing serum uric acid to below target levels in clinical trials—often within two weeks— and reversing tophi and joint damage over time. Nonetheless, its administration is complicated by potential infusion reactions and the development of anti-drug antibodies, factors that influence clinician prescribing practices.

Market Penetration and Adoption

Despite its proven efficacy, KRYSTEXXA’s penetration remains limited compared to standard urate-lowering therapies due to safety concerns, high costs, and logistical considerations associated with intravenous infusions. The drug's utilization predominantly occurs within specialized rheumatology centers, further constraining its reach. Growth in demand hinges on expanding awareness among prescribers, improving safety profiles, and demonstrating long-term cost-effectiveness.

Competitive Environment

Existing and Emerging Treatments

Traditional therapies like allopurinol and febuxostat dominate the market, capturing a vast majority of gout patients. Their incremental improvements, lower costs, and oral administration favor their continued dominance. However, biologic alternatives such as pegloticase are positioned as salvage therapies for refractory cases.

Recent advancements include the development of novel urate-lowering agents and biologics—such as URC-101 (oral uricase) under investigation—that could challenge KRYSTEXXA's market share. Although none have yet surpassed KRYSTEXXA’s efficacy profile, their emergence could redefine treatment paradigms if proven superior or safer.

Pricing and Reimbursement Dynamics

KRYSTEXXA's high price point—list prices have ranged up to $55,000 per year—limits broad access. Reimbursement decisions are influenced by cost-effectiveness assessments, with payers scrutinizing long-term benefits versus expenses. Value-based contracting and utilization management are increasingly employed to balance market penetration with sustainable reimbursement.

Regulatory Developments and Lifecycle Management

Regulatory authorities monitor safety signals, particularly infusion reactions and antibody development, necessitating ongoing post-marketing surveillance. Novartis (manufacturer) continues to explore indications beyond gout, including off-label or expanded uses, aiming to extend the drug’s lifecycle and optimize revenue streams.

Financial Trajectory

Revenue Performance and Trends

Since its approval, KRYSTEXXA has demonstrated steady but modest revenue growth, with sales oscillating around $360 million globally in 2021. The drug's revenue is sensitive to factors such as market access restrictions, safety concerns, and competition. The COVID-19 pandemic also modestly impacted infusion-based therapies' utilization, though demand rebounded as healthcare systems recovered.

Revenue Drivers

• Market Expansion: Efforts to extend indications, including investigating broader use in gout-related complications or other hyperuricemia-driven conditions.
• Pricing Strategies: Adoption of value-based pricing models, outcomes-based contracts, and differential pricing in emerging markets.
• Patient Access Programs: Initiatives to mitigate financial barriers, thereby expanding eligible patient pools.

Cost Considerations and Margins

Manufacturing costs for biologics like KRYSTEXXA are relatively high but are decreasing with process improvements. Gross margins remain robust owing to the premium pricing but are subject to reimbursement pressures. R&D investments continue primarily in safety monitoring and potential pipeline expansion.

Future Outlook

The financial trajectory for KRYSTEXXA hinges on clinical advancements and market access strategies. If safety profiles improve and new indications are approved, sales could see an uptick. Conversely, stiff competition, pricing pressures, or safety concerns could temper growth.

Long-term, the drug’s revenue growth will be aligned with the expanded management of refractory gout and improvements in health economics that demonstrate cost savings through reduced hospitalizations or joint surgeries.

Market Challenges and Opportunities

Challenges

• Safety Profile & Patient Acceptance: Infusion reactions and immunogenicity limit widespread acceptance, necessitating better safety management and patient education.
• High Treatment Cost: The premium price restricts access, especially in markets with constrained healthcare budgets.
• Limited Patient Pool: Refractory gout represents a small niche, with growth constrained by the size of this population.
• Regulatory Risks: Post-marketing safety signals can influence approvals and reimbursement, creating financial uncertainty.

Opportunities

• Pipeline and Combination Therapies: Development of alternative formulations or combination therapies to mitigate immunogenicity.
• Expansion of Indications: Investigating use in adolescent or pediatric populations, or other uric acid-related disorders.
• Market Expansion: Increasing geographical penetration, particularly in emerging markets with rising gout prevalence.
• Cost-Effectiveness Demonstrations: Publishing real-world evidence to bolster reimbursement and clinician confidence.

Conclusion

KRYSTEXXA occupies a vital, yet specific, niche within the biologic and gout treatment landscape. While current market dynamics limit its widespread adoption, ongoing clinical advancements and strategic market access initiatives could enhance its growth trajectory. The financial outlook, while promising, remains sensitive to safety concerns, pricing pressures, and competitive innovations.

Key Takeaways

• KRYSTEXXA serves a specialized segment of gout patients with refractory disease, limiting its total addressable market.
• Market growth is dependent on expanding clinical safety profiles, demonstrated cost-effectiveness, and higher clinician awareness.
• Revenue remains stable but modest, with potential growth driven by pipeline developments and geographic expansion.
• Competitive pressures from emerging therapies and biosimilars may challenge its dominance in niche markets.
• Strategic management of reimbursement and safety risks will be critical to sustaining its financial trajectory.

---

FAQs

Q1: What factors primarily influence KRYSTEXXA’s market growth?
A: Its growth depends on expanding the refractory gout patient population, improving safety and tolerability, healthcare provider acceptance, reimbursement policies, and potential new indications.

Q2: How does KRYSTEXXA compare cost-wise with traditional gout therapies?
A: KRYSTEXXA's annual cost (~$55,000) is significantly higher than oral urate-lowering therapies like allopurinol, which typically cost a few hundred dollars annually. Its high cost limits access, emphasizing the need for cost-effectiveness evidence.

Q3: What safety concerns impact KRYSTEXXA’s adoption?
A: Infusion reactions, anaphylaxis, and the development of anti-drug antibodies pose safety concerns, potentially leading to treatment discontinuation and limiting clinician confidence.

Q4: Are there any promising pipeline products or alternatives to KRYSTEXXA?
A: Several investigational agents, including oral uricases and newer biologics, aim to overcome limitations of pegloticase but have yet to demonstrate superior safety or efficacy profiles.

Q5: What market strategies could enhance KRYSTEXXA’s financial prospects?
A: Strategies include expanding indications, improving safety management, adopting value-based reimbursement agreements, entering new geographical markets, and developing patient support programs.

---

References

[1] Centers for Disease Control and Prevention. Gout Prevalence Data, 2019.
[2] Roddy, E. et al. (2012). "The Refractory Gout Subpopulation: A Systematic Review," Arthritis & Rheumatism.
[3] Novartis Pharmaceuticals. KRYSTEXXA Prescribing Information, 2022.