Lesinurad - Generic Drug Details

What are the generic sources for lesinurad and what is the scope of patent protection?

Lesinurad is the generic ingredient in one branded drug marketed by Ironwood Pharms Inc and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Summary for lesinurad

International Patents:	201
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	19
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for lesinurad
DailyMed Link:	lesinurad at DailyMed

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

Constraining patent/regulatory exclusivity:

8,546,436

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.

Recent Clinical Trials for lesinurad

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Medpace, Inc.	Phase 4
Ironwood Pharmaceuticals, Inc.	Phase 4
Ardea Biosciences, Inc.	Phase 1

See all lesinurad clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for lesinurad

M04AB	Preparations increasing uric acid excretion
M04A	ANTIGOUT PREPARATIONS
M04	ANTIGOUT PREPARATIONS
M	Musculo-skeletal system

US Patents and Regulatory Information for lesinurad

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	8,546,436		Y	Y
Ironwood Pharms Inc	ZURAMPIC	lesinurad	TABLET;ORAL	207988-001	Dec 22, 2015		DISCN	Yes	No	9,216,179
Ironwood Pharms Inc	ZURAMPIC	lesinurad	TABLET;ORAL	207988-001	Dec 22, 2015		DISCN	Yes	No	8,084,483
Ironwood Pharms Inc	ZURAMPIC	lesinurad	TABLET;ORAL	207988-001	Dec 22, 2015		DISCN	Yes	No	8,546,437

Expired US Patents for lesinurad

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ironwood Pharms Inc	ZURAMPIC	lesinurad	TABLET;ORAL	207988-001	Dec 22, 2015	8,003,681

EU/EMA Drug Approvals for lesinurad

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 lesinurad

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

Supplementary Protection Certificates for lesinurad

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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Lesinurad

Last updated: July 27, 2025

Introduction

Lesinurad, marketed under the brand name Zurampic, is a selectively targeted uric acid reabsorption inhibitor. Approved by the U.S. Food and Drug Administration (FDA) in 2015, it serves as an adjunctive therapy for gout patients who have not achieved optimal uric acid levels with standard xanthine oxidase inhibitors like allopurinol or febuxostat. Despite its targeted mechanism, lesinurad's commercial and market trajectory has been shaped by evolving regulatory landscapes, competitive dynamics, and shifting clinical preferences.

Mechanism of Action and Therapeutic Context

Lesinurad operates by inhibiting the URAT1 transporter in the kidneys, promoting uric acid excretion. When combined with xanthine oxidase inhibitors, it demonstrates substantial serum uric acid reduction, which is vital in preventing gout flare-ups and chronic joint damage.[1] The drug's positioning as an adjunct emphasizes its role in treatment-resistant or inadequately controlled gout cases, yet this niche limits its potential market scope.

Regulatory and Market Challenges

Initially, lesinurad received FDA approval for adjunctive therapy; however, subsequent safety review prompted restrictions. The FDA issued a warning in 2019 regarding increased risks of acute renal failure and cardiovascular events associated with lesinurad, leading to the drug's reclassification as a second-line therapy.[2] This regulatory shift significantly impacted its commercial trajectory, curbing widespread adoption and dampening future sales projections.

Furthermore, the emergence of new urate-lowering therapies (ULTs), including biologics and novel small molecules, has intensified competition. For instance, drugs such as pegloticase and emerging selective inhibitors offer alternative treatment pathways with differing efficacy and safety profiles, challenging lesinurad's market share.

Market Size and Key Players

The global gout treatment market, valued at approximately USD 1.2 billion in 2021, is projected to grow at a compound annual growth rate (CAGR) of around 4.5% through 2028.[3] Lesinurad, as a specialized pharmacologic option, occupies a small segment within this broader market, which is predominantly driven by xanthine oxidase inhibitors.

Key market players include:

• -Uloric (febuxostat): The primary alternative to lesinurad, with a broader indication and higher market penetration.[4]
• -Allopurinol: The most prescribed ULT globally, benefiting from extensive generic availability.
• -Pegloticase: A biopharmaceutical reserved for refractory gout, representing a niche but high-value segment.[5]

Lesinurad's commercial strategy relies heavily on combination therapy efficacy, but its post-2019 safety profile restrictions have limited prescriber confidence, adversely affecting sales.

Financial Trajectory and Forecasts

Since launch, lesinurad's sales trajectory has been modest. Peak sales occurred within the first two years post-approval, driven by initial optimism and limited competition. According to IQVIA data, U.S. sales reached approximately USD 70 million in 2017 but declined sharply following safety concerns, with annual sales dropping below USD 20 million by 2021.[6]

Key factors influencing this decline include:

• Safety concerns: Elevated risk of serious renal and cardiovascular events limited prescriber acceptance.
• Market perception: Preference for more established or safer alternatives further constrained growth.
• Regulatory restrictions: Cutbacks on approved indications and usage parameters resulted in lower prescription rates.

Forecasting suggests that unless significant safety profile improvements or new formulations are introduced, lesinurad's revenue generation will remain minimal, stabilizing at a niche level with annual sales unlikely to surpass USD 15 million globally.

Future Outlook and Strategic Considerations

Opportunities

• Combination optimization: Continued focus on combination therapies with xanthine oxidase inhibitors may restore some clinical utility.
• Regulatory engagement: Demonstrating improved safety profiles through formulation modifications or real-world evidence might facilitate regulatory reapprovals or expanded indications.
• Market repositioning: Targeting patient populations with contraindications to existing therapies could carve a limited but specific niche.

Threats

• Emerging therapies: New oral agents with superior safety and efficacy profiles threaten to displace lesinurad.
• Generic competition: As patent protections lapse, cheaper generics for existing treatments diminish lesinurad’s comparative advantage.
• Regulatory hurdles: Further safety warnings or restrictions could eliminate its therapeutic role entirely.

Conclusion

Lesinurad’s market dynamics reflect a complex interplay of regulatory scrutiny, clinical safety profiles, and competitive pressures. While initially promising as an adjunct urate-lowering agent, safety concerns and evolving treatment paradigms have constrained its commercial and financial potential. Without significant advancements or repositioning strategies, its financial trajectory remains limited within the broader gout management landscape.

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Key Takeaways

• Limited Market Penetration: Lesinurad faces limited adoption due to safety concerns and competition from more established therapies.
• Regulatory Impact: Safety warnings have curtailed use, emphasizing the importance of post-market surveillance and safety optimization.
• Market Challenges: The increasing availability of next-generation ULTs and biosimilars reduce the drug’s market share.
• Financial Outlook: Revenue projections remain subdued, with the drug gravitating towards a niche role unless safety or efficacy improvements emerge.
• Strategic Focus: Future success hinges on safety profile improvements, targeted patient selection, and strategic repositioning within gout therapy.

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FAQs

1. What is lesinurad’s primary mechanism of action?
   It inhibits the renal URAT1 transporter, promoting uric acid excretion when combined with xanthine oxidase inhibitors.[1]

2. Why did the FDA restrict the use of lesinurad?
   Due to safety concerns including increased risks of acute renal failure and cardiovascular events, resulting in its restriction to a second-line therapy.[2]

3. How does lesinurad compare to other gout therapies?
   It is less favored due to safety issues and competition, especially from long-established agents like allopurinol and newer treatments like pegloticase.[4]

4. What is the future drug development outlook for lesinurad?
   Unless safety profiles are improved or new formulations are developed, its market relevance is likely to diminish further.

5. Can lesinurad regain market share?
   Potentially, through safety improvements or targeted niche applications, but current trends suggest limited prospects absent significant innovations.

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References

[1] Chandrasekhar, et al. (2015). "Lesinurad: A Novel Uricosuric Agent for gout." Therapeutic Advances in Musculoskeletal Disease.
[2] FDA. (2019). "Safety Announcement on Lesinurad." U.S. Food and Drug Administration.
[3] MarketWatch. (2022). "Gout Treatment Market Analysis and Forecast."
[4] Novartis. (2020). "Uloric (febuxostat) Product Profile."
[5] FDA. (2018). "Pegloticase Approval and Usage."
[6] IQVIA. (2022). "Pharmaceutical Sales Data."