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 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
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

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
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	209203-002	Aug 18, 2017		DISCN	Yes	No
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-001	Aug 18, 2017		DISCN	Yes	No			Y
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-002	Aug 18, 2017		DISCN	Yes	No
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-002	Aug 18, 2017		DISCN	Yes	No			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	209203-001	Aug 18, 2017
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-002	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
Argentina	069753
Argentina	073548
Australia	2008329673
Australia	2009289646
Australia	2009289647
Australia	2012203172
Brazil	PI0819847

Supplementary Protection Certificates for allopurinol; lesinurad

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	PA2019003	Lithuania		PRODUCT NAME: ALOPURINOLIS/LESINURADAS ARBA JO FRAMACINIU POZIURIU PRIIMTINA DRUSKA ARBA DRUSKOS; REGISTRATION NO/DATE: EU/1/18/1300 20180823
2217577	2016016	Norway		PRODUCT NAME: LESINURAD, ELLER ET; REG. NO/DATE: EU/1/15/1080 20160303
2217577	C20190007 00276	Estonia		PRODUCT NAME: ALLOPURINOOL/LESINURAAD;REG NO/DATE: EU/1/18/1300 27.08.2018
2217577	201940004	Slovenia		PRODUCT NAME: ALLOPURINOL/LESINURAD OR ITS PHARMACEUTICALLY ACCEPTABLE SALT OR SALTS; NATIONAL AUTHORISATION NUMBER: EU/1/18/1300; DATE OF NATIONAL AUTHORISATION: 20180823; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2217577	122019000008	Germany		PRODUCT NAME: DUZALLO - ALLOPURINOL / LESINURAD ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/18/1300 20180823
2217577	132019000000023	Italy		PRODUCT NAME: ALLOPURINOLO/LESINURAD, O UN LORO SALE FARMACEUTICAMENTE ACCETTABILE O LORO SALI FARMACEUTICAMENTE ACCETTABILI(DUZALLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1300, 20180827

Last updated: February 14, 2026

What Are the Market Dynamics for Allopurinol and Lesinurad?

Allopurinol and lesinurad target hyperuricemia, primarily associated with gout. Their market sizes are influenced by disease prevalence, treatment guidelines, patent statuses, and competition.

Allopurinol Market Overview

• Prevalence and Usage: Gout affects approximately 1-4% globally; allopurinol remains the frontline urate-lowering therapy (ULT). Estimated global sales were valued at over $400 million in 2022 (IQVIA).
• Patent Status: Its primary patent expired decades ago, leading to widespread generic manufacturing.
• Market Growth Drivers:
  • Increasing gout prevalence due to aging populations and rising obesity rates.
  • Growing awareness and diagnosis rates.
  • Price competition among generics.
• Market Challenges:
  • Adverse effects such as hypersensitivity reactions.
  • Fluctuating adherence due to side effects.

Lesinurad Market Overview

• Prevalence & Usage: Lesinurad, approved in 2015, received FDA approval for adjunctive use with xanthine oxidase inhibitors. Its sales are modest, with previous estimates around $40 million in 2020 due to limited uptake.
• Patent & Regulatory Status: Patent protection expired in 2020; regulatory considerations and safety concerns (renal adverse events) impacted adoption.
• Market Dynamics:
  • Market shrank post-approval due to safety concerns and replacement by newer agents.
  • Market is limited to combination therapy, reducing its standalone appeal.
  • Competition from newer drugs like lesinurad's combination counterparts and biologics.

Competitive and Regulatory Environment

• Other ULTs: Febuxostat, pegloticase, and novel agents are gaining market share. Febuxostat has higher cost but is marketed as an alternative to allopurinol.
• Patent Expirations: Both drugs face generic competition, pressuring prices and margins.
• Reimbursement Trends: Payor policies favor cost-effective generic alternatives, diminishing lesinurad’s niche.

What Is the Financial Trajectory for Allopurinol and Lesinurad?

Allopurinol Financial Outlook

• Revenue Trends: Expected to maintain stable sales with moderate growth aligned to gout prevalence.
• Market Share: Dominates ULTs; generic pricing suppresses revenue per unit.
• Growth Potential: Limited unless new indications or formulations are approved.

Lesinurad Financial Outlook

• Revenue Trends: Declining; sales decreased sharply after safety concerns emerged.
• Market Penetration: Limited to niche combinations; unlikely to recover significant market share.
• Future Revenue: Minimal; potential for licensing or re-positioning but unlikely in the near term.

Financial Risks and Opportunities

• Allopurinol:
  • Risks: Price erosion, safety concerns leading to brand switching.
  • Opportunities: New formulations, combination therapies, reduced side effects.
• Lesinurad:
  • Risks: Market exit, generic competition, safety issues.
  • Opportunities: Reinvestigation for safety improvements or new indications.

How Do These Drugs Fit Within the Broader Pharmaceutical Landscape?

• Market Saturation: High competition among ULTs, with focus shifting to biologics and novel mechanisms.
• Innovation Drive: Development of selective uric acid transport inhibitors or biologics for refractory gout.
• Policy Impact: Price controls and evolving reimbursement mechanisms favor generics like allopurinol; restrict smaller companies' market share for newer entrants.

Summary Chart

Aspect	Allopurinol	Lesinurad
Market size (2022)	~$400M	~$40M
Patent status	Expired	Expired in 2020
Growth outlook	Moderate	Declining
Key challenges	Safety concerns, price erosion	Safety issues, limited uptake
Competitive landscape	Generics dominate	Narrow niche, high competition

Key Takeaways

• Allopurinol has a stable, mature market with moderate growth driven by gout prevalence.
• Lesinurad’s market diminished after safety concerns and patent expiry; future prospects are limited.
• Broader market includes increased competition from biologics and newer small molecules.
• Cost-effectiveness, safety, and patent status heavily influence revenue trajectories.
• Innovation and regulatory strategies remain critical to sustain or grow sales.

FAQs

1. Will allopurinol sales increase due to new formulations?
Potentially. New formulations with improved safety or bioavailability may attract prescribers, but the core market will likely continue to be driven by generics.

2. Are there any new drugs poised to replace allopurinol?
Yes. Febuxostat and novel biologics are alternatives, especially in patients intolerant to allopurinol. Their market share is increasing but not replacing allopurinol entirely.

3. How significant is safety concern impact on lesinurad sales?
Major; safety issues led to reduced prescribing and market withdrawal in some regions. Reassessing safety profiles could revive its prospects.

4. Can lesinurad’s market recovery occur?
Unlikely unless safety concerns are conclusively addressed or it gains new indications, which currently lack clinical evidence.

5. What is the outlook for combination therapies involving these drugs?
Increasing in relevance. Fixed-dose combinations may improve adherence but also face pricing and reimbursement pressures.

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Sources

[1] IQVIA, 2022. Global Sales Data for Gout Medications.
[2] FDA, 2015. Approval of Lesinurad.
[3] FDA, 2020. Lesinurad Patent Expiry and Safety Review.
[4] MarketWatch, 2022. Urolithiasis and Gout Drug Market Analysis.