allopurinol; lesinurad - Profile

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 eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Allopurinol; lesinurad has one hundred and forty-four patent family members in thirty-nine countries.

Summary for allopurinol; lesinurad

International Patents:	144
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for allopurinol; lesinurad

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

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 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	209203-001	Aug 18, 2017		DISCN	Yes	No
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-001	Aug 18, 2017		DISCN	Yes	No
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-001	Aug 18, 2017		DISCN	Yes	No
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-001	Aug 18, 2017		DISCN	Yes	No

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
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-001	Aug 18, 2017

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	Withdrawn	no	no	no	2018-08-23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
Hungary	E031766
Tunisia	2010000237	NOVEL COMPOUNDS AND COMPOSITIONS AND METHODS OF USE
South Korea	20110050709
World Intellectual Property Organization (WIPO)	2010028190

Supplementary Protection Certificates for allopurinol; lesinurad

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2217577	2019C/502	Belgium		PRODUCT NAME: DUZALLO - ALLOPURINOL / LESINURAD OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN DE SES SELS; AUTHORISATION NUMBER AND DATE: EU/1/18/1300 20180827
2217577	CR 2019 00003	Denmark		PRODUCT NAME: ALLOPURINOL AND LESINURAD OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1300 20180827
2217577	19C1004	France		PRODUCT NAME: ALLOPURINOL/LESINURAD OU UN/DES SEL(S) PHARMACEUTIQUEMENT ACCEPTABLE(S) DE CELUI-CI; REGISTRATION NO/DATE: EU/1/18/1300 20180827

Allopurinol; lesinurad Market Analysis and Financial Projection

Last updated: February 4, 2026

What Are the Investment Fundamentals for Allopurinol and Lesinurad?

Allopurinol and Lesinurad are drugs used to treat gout by controlling uric acid levels. Their market potential depends on patent status, clinical efficacy, regulatory position, and competitive landscape. This analysis examines each drug's current market status, growth drivers, and risks.

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What Is the Current Market Status for Allopurinol?

Allopurinol, a xanthine oxidase inhibitor, has been on the market since the 1960s. It is available as a generic medication worldwide.

Aspect	Details
Patent status	No patent exclusivity; off-patent globally
Market share	Dominates gout treatment, capturing approximately 80-90% of total gout drug sales
Sales volume	Estimated global sales of $1.5 billion in 2022 (IQVIA)
Orphan status	None; widely prescribed

Key Drivers:
Generic availability ensures low cost and high accessibility. Clinical guidelines favor allopurinol as first-line therapy for gout.
Risks:
Competition from newer agents like febuxostat or uricosurics. Off-label use in other hyperuricemia conditions may influence sales.

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What Is the Market Status and Future Potential of Lesinurad?

Lesinurad, a URAT1 transporter inhibitor, was approved by the FDA in 2016 but faced safety concerns leading to limited adoption.

Aspect	Details
Patent status	Patent protection expired around 2018; marketed as a branded drug (Zurampic) in combination with allopurinol
Market share	Low; sales reportedly under $50 million in 2022
Regulatory status	Withdrawn or limited in some markets due to safety issues, including increased cardiovascular risk
Clinical efficacy	Effective as an adjuvant to xanthine oxidase inhibitors, but safety concerns hinder broader use

Key Drivers:
Potential expansion in combination therapy markets.
Risks:
History of safety concerns, limited market adoption, and lack of robust competitive positioning.

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What Are the Market Dynamics and Growth Drivers?

Gout Market Overview

Indicator	Data
Global gout prevalence	~4% of adults (approx. 400 million people) (Kuo et al., 2015)
Growth rate	Estimated annual increase of 2%–3% in some regions
Treatment unmet needs	Patients intolerant to standard therapy, unmet need for safer drugs

Regulatory Environment

• Allopurinol: No recent patent expiry; well-established safety profile.
• Lesinurad: Limited market potential due to safety issues and patent expiry.

Competitive Landscape

Competitors	Drugs	Patent Status	Market Share
Febuxostat (Uloric)	Xanthine oxidase inhibitor	Patent expired in some regions	Moderate; replacing allopurinol for some patients
Uricosurics	Probenecid, pegloticase	Varies	Smaller niches; pegloticase for refractory cases

Innovation and R&D

• Allopurinol generics dominate due to established efficacy and safety.
• Limited pipeline for Lesinurad; focus has shifted to newer agents with better safety profiles.

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What Are the Investment Risks and Opportunities?

Risks

• Patent expiration reducing potential revenues for allopurinol increases exposure to generics.
• Lesinurad’s safety profile limits its market adoption.
• Market growth is constrained by competition from newer, safer agents like febuxostat and lesinurad alternatives.

Opportunities

• Development of next-generation uric acid-lowering drugs with favorable safety profiles.
• Niche uses in hyperuricemia management beyond gout.
• Potential reformulation or combination therapies to mitigate safety concerns.

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How Does the Market Outlook Influence Investment Decisions?

Scenario	Implication
Continued dominance of allopurinol with generic proliferation	Marginal profit margins; focus shifts to niche or innovative therapies
Emerging safety concerns for existing drugs	Investment in novel drugs or combination therapies gains favor
Regulatory shifts favoring newer agents	Higher revenue potential for innovator brands

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Key Takeaways

• Allopurinol has a stable, mature market with significant residual sales driven by affordability and guideline endorsement but faces pricing pressures due to patent expiry.
• Lesinurad experienced limited adoption due to safety concerns and a limited market footprint; its future remains uncertain.
• Market growth hinges on unmet needs and the development of safer, more effective drugs.
• The competitive landscape favors innovation with better safety profiles; existing drugs face pricing and patent expiration challenges.
• Investment potential depends on drug pipeline success, regulatory changes, and shifting treatment paradigms.

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FAQs

1. What is the main limitation of allopurinol in the market?
   The main limitation is its patent expiry, leading to widespread generic competition and price erosion.

2. Should investors consider Lesinurad for future growth?
   Limited due to safety concerns, low market penetration, and patent expiration; opportunities are minimal unless safety profile improvements occur.

3. Are there new drugs that could replace allopurinol?
   Yes, febuxostat and lesinurad have been used as alternatives, but safety issues and regulatory decisions impact their adoption.

4. What regulatory factors influence market prospects?
   Safety concerns and regulatory restrictions, especially for drugs like Lesinurad, influence market development.

5. What is the pipeline for advanced uric acid-lowering therapies?
   Several candidates are in clinical trials, focusing on safety and efficacy improvements over existing treatments.

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References

[1] Kuo, C. F., Grainge, M., Mallen, C., Doherty, M., & Zhang, W. (2015). Global epidemiology of gout: prevalence, incidence, and risk factors. Nature Reviews Rheumatology, 11(11), 649-662.