ZURAMPIC Drug Patent Profile

Which patents cover Zurampic, and what generic alternatives are available?

Zurampic is a drug marketed by Ironwood Pharms Inc and is included in one NDA. There are nine patents protecting this drug.

This drug has two hundred and one patent family members in forty-three countries.

The generic ingredient in ZURAMPIC is lesinurad. Additional details are available on the lesinurad profile page.

DrugPatentWatch^® Generic Entry Outlook for Zurampic

Zurampic was eligible for patent challenges on December 22, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 29, 2032. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ZURAMPIC

International Patents:	201
US Patents:	9
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	92
Patent Applications:	329
Drug Prices:	Drug price information for ZURAMPIC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZURAMPIC
DailyMed Link:	ZURAMPIC at DailyMed

See drug prices for ZURAMPIC

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ZURAMPIC

NDA:

207988

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for ZURAMPIC

ZURAMPIC is protected by twelve US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ironwood Pharms Inc	ZURAMPIC	lesinurad	TABLET;ORAL	207988-001	Dec 22, 2015		DISCN	Yes	No
Ironwood Pharms Inc	ZURAMPIC	lesinurad	TABLET;ORAL	207988-001	Dec 22, 2015		DISCN	Yes	No
Ironwood Pharms Inc	ZURAMPIC	lesinurad	TABLET;ORAL	207988-001	Dec 22, 2015		DISCN	Yes	No				Y
Ironwood Pharms Inc	ZURAMPIC	lesinurad	TABLET;ORAL	207988-001	Dec 22, 2015		DISCN	Yes	No
Ironwood Pharms Inc	ZURAMPIC	lesinurad	TABLET;ORAL	207988-001	Dec 22, 2015		DISCN	Yes	No
Ironwood Pharms Inc	ZURAMPIC	lesinurad	TABLET;ORAL	207988-001	Dec 22, 2015		DISCN	Yes	No			Y
Ironwood Pharms Inc	ZURAMPIC	lesinurad	TABLET;ORAL	207988-001	Dec 22, 2015		DISCN	Yes	No

Expired US Patents for ZURAMPIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ironwood Pharms Inc	ZURAMPIC	lesinurad	TABLET;ORAL	207988-001	Dec 22, 2015

EU/EMA Drug Approvals for ZURAMPIC

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Grünenthal GmbH	Zurampic	lesinurad	EMEA/H/C/003932Zurampic, in combination with a xanthine oxidase inhibitor, is indicated in adults for the adjunctive treatment of hyperuricaemia in gout patients (with or without tophi) who have not achieved target serum uric acid levels with an adequate dose of a xanthine oxidase inhibitor alone.,	Withdrawn	no	no	no	2016-02-18

International Patents for ZURAMPIC

When does loss-of-exclusivity occur for ZURAMPIC?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

New Zealand

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ZURAMPIC around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20130105902	POLYMORPHIC FORMS OF 2-(5-BROMO-4-(4-CYCLOPROPYLNAPHTHALEN-1-YL)-4H-1,2,4-TRIAZOL-3-YLTHIO)ACETIC ACID AND USES THEREOF
Israel	205974
Hong Kong	1180337
Spain	2380604
Cyprus	1118621
South Africa	201101626	COMPOUNDS,COMPOSITIONS AND METHODS OF USING SAME FOR MODULATING URIC ACID LEVELS
South Africa	201101626	COMPOUNDS,COMPOSITIONS AND METHODS OF USING SAME FOR MODULATING URIC ACID LEVELS

Supplementary Protection Certificates for ZURAMPIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2217577	2016016	Norway		PRODUCT NAME: LESINURAD, ELLER ET; REG. NO/DATE: EU/1/15/1080 20160303
2217577	PA2019003	Lithuania		PRODUCT NAME: ALOPURINOLIS/LESINURADAS ARBA JO FRAMACINIU POZIURIU PRIIMTINA DRUSKA ARBA DRUSKOS; REGISTRATION NO/DATE: EU/1/18/1300 20180823
2217577	C201930004	Spain		PRODUCT NAME: ALOPURINOL + LESINURAD; NATIONAL AUTHORISATION NUMBER: EU/1/18/1300; DATE OF AUTHORISATION: 20180823; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1300; DATE OF FIRST AUTHORISATION IN EEA: 20180823
2135608	PA2016024,C2135608	Lithuania		PRODUCT NAME: LESINURADAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/15/1080 20160218
2217577	CR 2019 00003	Denmark		PRODUCT NAME: ALLOPURINOL AND LESINURAD OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1300 20180827
2135608	34/2016	Austria		PRODUCT NAME: LESINURAD ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1080 (MITTEILUNG) 20160222
2135608	300825	Netherlands		PRODUCT NAME: LESINURAD; REGISTRATION NO/DATE: EU/1/15/1080 20160222

Market Dynamics and Financial Trajectory for ZURAMPIC

Last updated: July 29, 2025

Introduction

ZURAMPIC (febuxostat) is a prescription medication developed for the management of hyperuricemia in patients with gout. Approved by the U.S. Food and Drug Administration (FDA) in February 2019, ZURAMPIC's market positioning is rooted in its targeted mechanism for lowering serum uric acid levels, distinguishing it from other gout treatments. This analysis explores the market dynamics impacting ZURAMPIC's commercial prospects and provides insights into its financial trajectory amid evolving industry trends.

Pharmacological Profile and Clinical Positioning

ZURAMPIC operates as a non-purine selective xanthine oxidase inhibitor, designed to reduce uric acid production. Compared to allopurinol and febuxostat, ZURAMPIC's mechanism offers a potentially favorable safety profile, especially in patients with multiple comorbidities. Its clinical trials demonstrated efficacy in lowering serum uric acid, yet safety concerns, particularly cardiovascular risks associated with febuxostat, have influenced prescribing behaviors [1].

Market Landscape for Gout Therapeutics

The gout marketplace is highly competitive, dominated by established agents like allopurinol, febuxostat, and uricosuric drugs such as probenecid. The global gout treatment market was valued at approximately USD 3.2 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of around 7% through 2028 [2].

Key Market Drivers:

• Rising Prevalence of Gout: Increased incidence linked to aging populations, metabolic syndrome, and obesity. The CDC reports a gout prevalence of approximately 4% among U.S. adults, with higher rates among men and certain racial groups [3].

• Unmet Medical Needs: Suboptimal response or intolerance to existing therapies creates opportunities for innovative treatments like ZURAMPIC.

• Healthcare Policy and Reimbursement Trends: Reimbursement frameworks favor drugs demonstrating superior safety, efficacy, and cost-effectiveness, influencing market penetration.

Regulatory and Safety Considerations

The initial FDA approval of ZURAMPIC was supported by its efficacy in lowering uric acid, but subsequent safety signals, notably cardiovascular concerns, have impacted its adoption. The FDA has issued warnings and updated labeling to address these risks. Such safety issues often restrict prescribing to specialized settings and limit aggressive marketing strategies.

Impact on Market Adoption:

• Physicians may prefer first-line agents like allopurinol due to familiarity and established safety profile.
• ZURAMPIC’s positioning may be limited to patients intolerant or resistant to other treatments.
• The safety profile could influence formulary placement and insurance reimbursement, affecting sales volume.

Competitive Dynamics

While ZURAMPIC offers an alternative mechanism, its market share remains limited relative to dominant drugs like allopurinol and febuxostat.

Major Competitors:

• Allopurinol: Market leader, generic availability, low cost, extensive clinical experience.
• Febuxostat: Similar mechanism, but safety concerns have impacted its use.
• Uricosurics: Less frequently prescribed due to dietary restrictions and variable efficacy.

Emerging therapies—such as pegloticase and novel biologics—further fragment the market, creating a challenging environment for ZURAMPIC.

Pricing and Reimbursement Landscape

Pricing strategies for ZURAMPIC are influenced by patent status, competition, and reimbursement policies. As a branded drug, ZURAMPIC initially commanded premium pricing, but potential biosimilar or generic versions of competitor drugs exert downward pressure.

Insurance coverage is contingent on clinical efficacy, safety profile, and formulary inclusion. The safety signals associated with febuxostat have led to cautious prescribing, which constrains revenue growth.

Financial Trajectory

Sales Performance:
Since its 2019 launch, ZURAMPIC’s sales have been modest, constrained primarily by safety concerns and competitive pressures. The drug’s revenue trajectory aligns with typical pharma biopharmaceutical products encountering incremental adoption unless driven by significant clinical advantages.

Revenue Forecast:
Projected revenues for ZURAMPIC are modest, possibly reaching USD 150-200 million globally over the next five years, assuming increased adoption in niche populations. Factors influencing growth include:

• Expanded Indications: Potential approval for other hyperuricemia-related conditions.
• Combination Therapies: Partnering with other agents to enhance efficacy and safety.
• Market Expansion: Entry into emerging markets with high gout prevalence.

Cost Structure and R&D Investment:
Continued R&D investments in safety profiling and new formulations could stabilize or enhance market acceptance. However, cost pressures from insurance payers and competitive pricing schemes pose risks to profitability.

Strategic Outlook

The future of ZURAMPIC hinges on its ability to differentiate itself through improved safety and efficacy, secure favorable reimbursement, and expand indications. Its trajectory will be shaped by:

• Regulatory developments addressing safety profiles.
• Market acceptance driven by clinician confidence.
• Competitive innovation providing superior treatment options.

In sum, ZURAMPIC’s financial success is currently limited but possesses growth potential within a carefully navigated niche market, contingent on safety management and targeted marketing strategies.

Key Takeaways

• Market Positioning: ZURAMPIC operates in a competitive, mature market with limited upside unless safety concerns are effectively addressed.
• Revenue Potential: Expected to generate modest revenues, with significant dependence on safety profile management and clinical differentiation.
• Strategic Focus: Emphasis on safety, expanding indications, and market education is essential for improved market penetration.
• Competitive Challenges: Agenda includes competing against low-cost generics and navigating safety signals impacting prescribing habits.
• Long-term Outlook: Prospects depend on regulatory responses and innovations that can elevate ZURAMPIC's therapeutic profile amid evolving gout treatments.

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FAQs

1. What are the main safety concerns associated with ZURAMPIC?
ZURAMPIC shares similar cardiovascular safety concerns as febuxostat, including increased risks of heart-related adverse events, prompting caution in its prescribing and labeling updates.

2. How does ZURAMPIC compare to allopurinol in treating gout?
While ZURAMPIC offers a targeted mechanism with potential safety advantages in specific populations, allopurinol remains the first-line treatment owing to its lower cost, longer clinical track record, and broad prescribing familiarity.

3. What factors determine ZURAMPIC’s market share?
Market share is influenced by safety profiles, clinical efficacy, reimbursement policies, physician prescribing habits, and the emergence of alternative therapies.

4. Can ZURAMPIC be used in combination therapy?
Yes, in certain cases, ZURAMPIC may be used alongside other agents such as uricosurics or anti-inflammatory drugs, but clinical evidence supporting combination regimens is limited, and safety considerations apply.

5. What is the outlook for ZURAMPIC’s global sales?
Global sales are expected to remain modest unless mitigative strategies improve its safety profile, expand indications, or the gout market experiences accelerated growth driven by demographic trends.

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Sources

[1] U.S. Food and Drug Administration. FDA Label for ZURAMPIC. 2019.
[2] Grand View Research. Gout Treatment Market Size & Share, 2021-2028. 2022.
[3] CDC. National gout prevalence and demographic data. 2020.