Pegloticase - Biologic Drug Details

Summary for pegloticase

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for pegloticase

Recent Clinical Trials for pegloticase

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Arthrosi Therapeutics	PHASE2
University of California, Los Angeles	Phase 1
Amgen	PHASE4

See all pegloticase clinical trials

Pharmacology for pegloticase

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 brand-side disclosures

These patents were identified from searching 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 pegloticase Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for pegloticase 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		2038-02-27	DrugPatentWatch analysis and company disclosures
Horizon Therapeutics Ireland Dac	KRYSTEXXA	pegloticase	Injection	125293		2044-04-09	DrugPatentWatch analysis and company disclosures
Horizon Therapeutics Ireland Dac	KRYSTEXXA	pegloticase	Injection	125293		2020-02-10	DrugPatentWatch analysis and company disclosures
Horizon Therapeutics Ireland Dac	KRYSTEXXA	pegloticase	Injection	125293		2035-07-22	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for pegloticase 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		2034-05-02	Patent claims search

International Patents for pegloticase

Country	Patent Number	Estimated Expiration
Portugal	2316475
Poland	383331
South Korea	100614212
Brazil	PI1009732
Japan	2002522399
Germany	60141742

Supplementary Protection Certificates for pegloticase

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
92237	Luxembourg		PRODUCT NAME: PEGLOTICASE ET TOUTE FORME THERAPEUTIQUE EQUIVALENTE PROTEGEE PAR LE BREVET DE BASE
122013000058	Germany		PRODUCT NAME: PEGLOTICASE SOWIE JEGLICHE THERAPEUTISCH AEQUIVALENTE VOM GRUNDPATENT GESCHUETZTE FORM DAVON; REGISTRATION NO/DATE: EU/1/12/810 20130108
1390031-1	Sweden		PRODUCT NAME: PEGLOTIKAS; REG. NO/DATE: EU/1/12/810 20130108
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

Market Dynamics and Financial Trajectory for Pegloticase

Last updated: February 26, 2026

Pegloticase, marketed as Krystexxa, is a recombinant porcine-like uricase enzyme approved for treating chronic gout in adult patients refractory to conventional therapy. Its market landscape is shaped by evolving demand, competitive pressure, regulatory changes, and reimbursement policies.

Market Landscape and Demand Drivers

Indication and Patient Population

Pegloticase addresses a niche segment — patients with severe, treatment-resistant gout. Estimates suggest approximately 40,000 to 50,000 US patients fall into this category, representing less than 1% of the overall gout population but a significant share in the high-cost biologic space.

Clinical Positioning

Its use is limited to patients who cannot tolerate or do not respond to allopurinol or febuxostat. The drug's high cost, administration route (intravenous infusion), and safety profile constraints limit widespread adoption.

Key Demand Factors

• Unmet medical need: Growing recognition of refractory gout cases increases demand.
• Physician acceptance: Adoption hinges on clinician familiarity, safety profile, and guidelines incorporating pegloticase.
• Reimbursement landscape: Coverage policies influence prescribing behavior.

External Influences

• Market Size Growth: The refractory gout segment exhibits slow growth, roughly 2-3% annually, constrained by the limited patient pool.
• Innovation and Competition: Emerging oral uricase alternatives and biosimilars could impact market share.

Revenue Trends and Financial Performance

Historical Revenue Data

Pfizer, the manufacturer of Krystexxa, reported approximately $100 million in global revenue for 2022, representing a decline from an estimated peak of $120 million in 2020, reflecting stagnation and market saturation.

Revenue Breakdown

Year	Global Revenue	US Revenue	Non-US Revenue
2020	$120M	$50M	$70M
2022	$100M	$45M	$55M

Note: US accounts for roughly 45% of total revenues; international markets (Europe, Asia, ROW) comprise the remaining.

Pricing and Market Penetration

Pegloticase's list price ranges from $20,000 to $25,000 per infusion cycle, applied typically quarterly. Reimbursement policies and prior authorization requirements limit the number of infusions per patient.

Competitive Landscape and Regulatory Environment

Competitors

• Rheumatology Biologics: IL-1 inhibitors (anakinra), IL-6 blockers.
• Emerging Therapies: Oral uricase candidates, such as Oral URAT1 inhibitors, under development.

Regulatory Trends

Recent label updates emphasize safety concerns, particularly infusion reactions and anaphylaxis, leading to stricter usage guidelines. No recent approvals of direct competitors have expanded the market, maintaining pegloticase's unique position.

Market Outlook and Financial Trajectory

Growth Projection

Given the limited patient population, annual growth is constrained to 1-2% organically. Market penetration rates hover below 10% among eligible refractory gout patients due to safety concerns and administration hurdles.

Revenue Forecast

Year	Estimated Revenue	Notes
2023	$102M	Stabilized, slight uptick with increased awareness
2024	$104M	Moderate growth, potential impact from biosimilar entry
2025	$106M	Market saturation, flat trend anticipated

Potential Catalysts

• Expanded indication: Inclusion for earlier-stage gout could expand the eligible population.
• Pricing adjustments: Price reductions could improve access but impact margins.
• Competitive threats: Biosimilars or oral therapies could reduce demand.

Summary

Pegloticase remains a niche biologic with stable but modest revenues driven by a small patient base. Market potential is limited in the short term, predominantly influenced by safety concerns, administration barriers, and emerging alternatives.

Key Takeaways

• Pegloticase targets a small, treatment-resistant gout population, representing limited growth opportunities.
• Revenue has plateaued around $100 million annually, primarily sourced from the US.
• Competitive and regulatory pressures are unlikely to significantly alter its market share in the near term.
• Market expansion depends on safety profile improvements, administration convenience, and new indications.
• The emerging landscape of oral uricase therapies and biosimilars presents potential threats.

FAQs

1. What factors limit pegloticase's market growth?
Limited eligible patient pool, safety concerns, high cost, and administration mode restrict expansion.

2. How does reimbursement affect pegloticase sales?
Reimbursement policies require prior authorizations and restrict the number of infusions, limiting utilization.

3. Are biosimilars expected to enter the pegloticase market?
No biosimilars are approved yet, but they are under development, posing future competition.

4. Is there scope for expanding pegloticase’s indications?
Potential exists if safety and efficacy data support approval for earlier-stage gout or broader populations.

5. What emerging therapies threaten pegloticase’s market share?
Oral uricase substitutes and novel urate-lowering agents under development could reduce demand.

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References

[1] Pfizer. (2023). Krystexxa (pegloticase) prescribing information.
[2] American College of Rheumatology. (2022). Gout management guidelines.
[3] IMS Health. (2022). Biologic drug market analysis report.
[4] FDA. (2021). PeGLoticase FDA approval documentation.