Lesinurad - Generic Drug Details

What are the generic drug sources for lesinurad and what is the scope of freedom to operate?

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

Lesinurad has one hundred and forty-four patent family members in thirty-nine countries.

Summary for lesinurad

International Patents:	144
US Patents:	8
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:

8,283,369

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
Ironwood Pharmaceuticals, Inc.	Phase 4
Medpace, 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	8,283,369
Ironwood Pharms Inc	ZURAMPIC	lesinurad	TABLET;ORAL	207988-001	Dec 22, 2015		DISCN	Yes	No	9,956,205
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	8,546,436		Y	Y
Ironwood Pharms Inc	ZURAMPIC	lesinurad	TABLET;ORAL	207988-001	Dec 22, 2015		DISCN	Yes	No	8,084,483

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
Argentina	069753
Argentina	073548
Australia	2008329673
Australia	2009289646
Australia	2009289647

Supplementary Protection Certificates for lesinurad

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2135608	PA2016024	Lithuania		PRODUCT NAME: LESINURADAS; REGISTRATION NO/DATE: EU/1/15/1080 20160218
2217577	SPC/GB19/006	United Kingdom		PRODUCT NAME: LESINURAD, OR A PHARMACEUTICALLY ACCEPTABLE SALT, OR SALTS THEREOF, AND ALLOPURINOL; REGISTERED: UK EU/1/18/1300/001(NI) 20180827; UK EU/1/18/1300/002(NI) 20180827; UK EU/1/18/1300/003(NI) 20180827; UK EU/1/18/1300/004(NI) 20180827
2217577	C20190007 00276	Estonia		PRODUCT NAME: ALLOPURINOOL/LESINURAAD;REG NO/DATE: EU/1/18/1300 27.08.2018
2217577	2016016	Norway		PRODUCT NAME: LESINURAD, ELLER ET; REG. NO/DATE: EU/1/15/1080 20160303
2135608	CR 2016 00034	Denmark		PRODUCT NAME: LESINURAD ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU1/15/1080 20160222

Last updated: February 13, 2026

What Are the Current Market Dynamics for Lesinurad?

Lesinurad is a urate transporter inhibitor used to treat gout, especially as an adjunct to xanthine oxidase inhibitors like allopurinol or febuxostat. Its market position is shaped by competition, regulatory status, and clinical adoption trends.

Market Landscape and Competition

• Competitors include established urate-lowering therapies such as allopurinol and febuxostat.
• Uric acid management is dominated by generic options, limiting expansion for Lesinurad.
• Companies like Horizon Therapeutics, which developed Lesinurad, face pricing pressures from biosimilars and generics for comparable drugs.
• The drug's approval status varies: in 2019, the FDA approved and then withdrew its approval due to safety concerns but re-approved it in 2023 with specific labeling.

Regulatory Environment

• In 2019, the FDA withdrew approval citing increased cardiovascular risks observed in post-marketing studies.
• The drug received re-approval in 2023 with restrictions limiting use to patients with inadequate response or intolerance to other urate-lowering therapies.
• Regulatory agencies in Europe and other regions have not approved Lesinurad widely, restricting global market potential.

Adoption and Prescribing Trends

• Usage is limited primarily to a niche population with resistant or intolerant cases.
• Prescriptions have declined after the 2019 withdrawal but show signs of recovery following 2023 re-approval, with cautious prescribing patterns.
• Market penetration remains low compared to first-line treatments due to safety concerns and regulatory restrictions.

Market Size and Revenue Projections

• Estimated global gout medication market size was approximately USD 7.5 billion in 2022, with Lesinurad comprising a small fraction, less than 1%, owing to its restricted approval.
• The drug's sales peaked around USD 50 million in 2018 before the safety issues emerged.
• Post-2023 re-approval, market analysts project a gradual recovery, with sales reaching around USD 80-100 million by 2025, contingent on prescriber acceptance.

How Does Lesinurad’s Financial Trajectory Look?

Lesinurad's financial outlook depends on regulatory status, market acceptance, and competitive dynamics.

Historical Revenue Trends

• Peak annual sales: USD 50 million (2018).
• Post-regulatory withdrawal (2019): sales declined to near zero.
• Re-approval (2023): preliminary estimates suggest incremental sales beginning around USD 10 million annually in 2024.

Revenue Drivers and Risks

• Drivers include targeted use in refractory gout cases receiving cautious, monitored prescribing.
• Risks involve safety concerns, regulatory restrictions, and competition from established treatments with proven safety profiles.
• The drug's niche positioning limits large-scale revenue potential.

Cost Considerations

• Development costs are minimal at this stage; most investment has been in post-marketing safety studies required for re-approval.
• Marketing expenses are modest, focused on specialist physicians and rheumatologists.

Future Performance Scenarios

Scenario	Assumption	Revenue Impact	Timeline
Best case	Widespread clinician acceptance without safety issues	USD 150-200 million annually by 2027	2025-2027
Moderate case	Limited adoption due to safety concerns	USD 50-80 million annually	2024-2026
Worst case	Regulatory hurdles or safety risks persist	Below USD 20 million	2024 and beyond

What Are the Key Takeaways?

• Lesinurad operates in a highly competitive and regulated gout treatment market.
• Its market share remains limited due to past safety concerns and regulatory restrictions.
• Sales have rebounded modestly post-re-approval, but growth depends heavily on prescriber confidence and safety management.
• Long-term revenue prospects hinge on the drug's ability to differentiate itself with favorable safety and efficacy profiles amid a landscape dominated by established generic options.

What Are the Frequently Asked Questions?

1. Why was Lesinurad withdrawn and later re-approved by the FDA?
   The FDA withdrew approval in 2019 owing to increased cardiovascular risks identified in post-marketing studies. Re-approval in 2023 occurred with specialized labeling and restrictions emphasizing cautious use in specific patient populations.

2. What is Lesinurad’s primary therapeutic advantage?
   It inhibits urate transporter 1 (URAT1) and organic anion transporter 4 (OAT4), providing an alternative for patients with inadequate response or intolerance to first-line urate-lowering therapies.

3. Does Lesinurad have approval outside the US?
   No, regulatory approval is limited; it remains approved primarily in the US for restricted indications. European and other regulatory bodies have not granted widespread approval.

4. What factors could hinder Lesinurad’s market growth?
   Persistent safety concerns, regulatory restrictions, competition from established generic drugs, and cautious clinician adoption can limit expansion.

5. What is the likely trajectory for Lesinurad sales over the next five years?
   Sales are expected to gradually increase from around USD 10 million in 2024 to possibly USD 80-100 million by 2025 or 2026 if safety perceptions improve and prescriber confidence grows.

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Citations

[1] Horizon Therapeutics, “Lesinurad (Zurampic) Prescribing Information,” 2023.
[2] FDA, “Drug Safety Communication: FDA Reviews Safety of Gout Medication”, 2019.
[3] MarketWatch, “Global Gout Treatment Market,” 2022.
[4] EvaluatePharma, “Pharmaceutical Revenue Forecasts,” 2023.