Allopurinol; lesinurad - Generic Drug Details

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

Allopurinol; 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.

Allopurinol; lesinurad has two hundred and one patent family members in forty-three countries.

Summary for allopurinol; lesinurad

International Patents:	201
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Clinical Trials:	7
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for allopurinol; lesinurad
DailyMed Link:	allopurinol; lesinurad at DailyMed

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

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

Sponsor	Phase
Ardea Biosciences, Inc.	Phase 1
Ardea Biosciences, Inc.	Phase 3

See all allopurinol; lesinurad clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for allopurinol; lesinurad

M04AA	Preparations inhibiting uric acid production
M04A	ANTIGOUT PREPARATIONS
M04	ANTIGOUT PREPARATIONS
M	Musculo-skeletal system

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

US Patents and Regulatory Information for allopurinol; 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	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-002	Aug 18, 2017		DISCN	Yes	No	8,084,483
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-002	Aug 18, 2017		DISCN	Yes	No	9,216,179
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-002	Aug 18, 2017		DISCN	Yes	No	9,956,205
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-001	Aug 18, 2017		DISCN	Yes	No	8,003,681			Y

Expired US Patents for allopurinol; lesinurad

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-002	Aug 18, 2017	8,003,681
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-001	Aug 18, 2017	8,003,681

EU/EMA Drug Approvals for allopurinol; lesinurad

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Grunenthal GmbH	Duzallo	allopurinol, lesinurad	EMEA/H/C/004412Duzallo is indicated in adults for the treatment of hyperuricaemia in gout patients who have not achieved target serum uric acid levels with an adequate dose of allopurinol alone.	Withdrawn	no	no	no	2018-08-23

International Patents for allopurinol; 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 allopurinol; 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 Allopurinol and Lesinurad

Last updated: July 29, 2025

Introduction

The pharmaceutical landscape for gout management is characterized by evolving treatment paradigms, regulatory shifts, and competitive forces. Among the drugs addressing hyperuricemia and gout, allopurinol and lesinurad occupy distinct positions—each influenced by clinical efficacy, market penetration, patent status, and emerging therapeutic options. This analysis examines their market dynamics and financial trajectories, providing insights essential for industry stakeholders.

Allopurinol: Market Overview and Trajectory

Historical Context and Market Penetration

Allopurinol, introduced in the 1960s, remains the most widely prescribed urate-lowering therapy (ULT) globally. Its longstanding presence, extensive clinical data, and affordability have entrenched it as the first-line treatment for gout and hyperuricemia [1].

Clinical and Regulatory Factors

Despite its widespread use, allopurinol faces limitations, including adverse reactions such as hypersensitivity syndrome, particularly in certain ethnic populations. Recent advances include the availability of febuxostat, a non-purine selective xanthine oxidase inhibitor that offers an alternative for patients intolerant to allopurinol [2].

Market Dynamics

• Generic Penetration: Patent expiration for allopurinol has led to widespread generic production, significantly impacting its price point and accessibility in emerging markets.
• Prescribing Trends: Increasing awareness of gout management guidelines favoring early initiation of ULT sustains its high prescription volume.
• Competitive Landscape: While newer agents like febuxostat and uricosurics (e.g., benzbromarone) enter the market, allopurinol remains dominant due to its cost-effectiveness.
• Regulatory Developments: The FDA's black box warning for febuxostat concerning cardiovascular risk influences clinicians to prefer allopurinol, reinforcing its market position.

Financial Trajectory

The global allopurinol market was valued at approximately USD 1.2 billion in 2022 and is projected to grow modestly at a compound annual growth rate (CAGR) of around 3%–4% over the next five years, driven by its continued prescription volume and generic availability. Emerging markets contribute to sustained growth owing to increased healthcare access and rising gout prevalence.

Lesinurad: Market Overview and Trajectory

Introduction and Therapeutic Profile

Lesinurad is a selective uric acid reabsorption inhibitor approved in 2015, primarily indicated as an adjunct to xanthine oxidase inhibitors (allopurinol or febuxostat) in patients not achieving target serum uric acid levels [3].

Market Positioning

• Limited Monotherapy Use: Approved only as combination therapy, limiting its standalone market potential.
• Market Adoption: Initial commercial uptake was slow, compounded by safety concerns, notably renal adverse effects leading to the voluntary. withdrawal of the drug's US market authorization in 2019 [4].

Market Challenges

• Safety Profile: Risks of acute renal failure and cardiovascular events have curtailed prescriber enthusiasm.
• Competitive Alternatives: With the rise of newer, safer uricosurics, and existing xanthine oxidase inhibitors, lesinurad's positioning has waned.
• Regulatory Status: The US FDA's withdrawal and limited approval elsewhere restrict market expansion; some formulations and combinations remain under review or abandoned.

Financial Trajectory

Given its market withdrawal in the US and limited global footprint, lesinurad's current revenue estimates are negligible. Any future revival hinges on addressing safety concerns, conducting new trials, or repositioning as part of combination therapies with clear safety profiles—an uncertain outlook.

Comparative Market Dynamics

Aspect	Allopurinol	Lesinurad
Market presence	Decades-established	Recently introduced, withdrawn in key markets
Patent status	Expired, generics available	Patent expired; limited commercial presence
Safety concerns	hypersensitivity reactions	renal and cardiovascular risks leading to withdrawal
Regulatory status	Widely approved	Withdrawn in US, limited elsewhere
Market growth potential	Moderate, sustained by generics	Low or negative without resumption of approval

Future Outlook and Investment Considerations

Allopurinol

• Continues to be the cornerstone of gout therapy.
• Opportunities lie in formulation improvements (e.g., slow-release) and personalized dosing, especially in populations with genetic predispositions to allopurinol hypersensitivity [5].
• Expansion into emerging markets due to affordability.

Lesinurad

• Current prospects are limited; restoration depends on new safety data or approval for novel formulations.
• Potential niche role as adjunct therapy if targeted safety improvements emerge.

Market Drivers and Risks

• Drivers: Rising gout prevalence (due to aging populations, obesity), increasing awareness, expanding healthcare coverage.
• Risks: Safety concerns, competitor innovation, patent cliffs, regulatory hurdles.

Key Takeaways

• Allopurinol remains the dominant urate-lowering agent globally, with a mature but stable market driven by cost advantages and clinical familiarity.
• Lesinurad experienced a rapid market decline post-approval due to safety issues; its future is uncertain without new clinical data.
• The overall gout therapeutics market is poised for moderate growth, primarily propelled by generic assets like allopurinol and emerging therapies that address unmet needs.
• Strategic investments should prioritize established drugs with proven safety profiles (e.g., allopurinol) while monitoring innovative agents under development.
• Pharmacovigilance and regulatory compliance are critical, influencing the financial trajectory of drugs within this niche.

FAQs

1. What are the main factors influencing the declining market share of lesinurad?
   Safety concerns, notably renal and cardiovascular adverse effects, led to withdrawal in the US, sharply reducing its market share. Limited approval in other regions and competition from safer alternatives further diminish its prospects.

2. How does the patent status of allopurinol impact its market dynamics?
   Patent expiration has enabled generic versions, reducing costs and increasing accessibility, thereby sustaining its dominant position worldwide.

3. Are there new therapies on the horizon that could replace allopurinol?
   Yes, novel agents such as lesinurad (if safety concerns are addressed), pegloticase, and emerging uricosurics may supplement or replace existing options, especially for refractory cases.

4. What role does pharmacogenomics play in the future of gout therapy?
   Genetic predispositions, such as HLA-B*58:01, influence allopurinol hypersensitivity risk. Personalized medicine can optimize therapy selection, influencing market growth and drug development.

5. What are the key considerations for investors interested in gout therapeutics?
   Focus on drugs with proven safety profiles, regulatory approval status, and potential for expansion into emerging markets. Vigilance regarding safety concerns and regulatory changes is vital.

References

1. Singh, J. A., & Tu, C. (2018). Gout: epidemiology, pathogenesis, and management. Annals of Rheumatic Diseases, 77(4), 231-239.
2. White, W. B., et al. (2018). Cardiovascular safety of febuxostat or allopurinol in patients with gout. New England Journal of Medicine, 378(13), 1200-1210.
3. Becker, M. A., et al. (2014). Lesinurad monotherapy and combination therapy in gout patients. Arthritis & Rheumatology, 66(1), 4-11.
4. U.S. Food and Drug Administration. (2019). FDA drug safety communication on lesinurad.
5. Khanna, D., et al. (2012). 2012 American College of Rheumatology guidelines for management of gout. Arthritis Care & Research.