ZURAMPIC Drug Patent Profile

Which patents cover Zurampic, and what generic alternatives are available?

Zurampic is a drug marketed by Ironwood Pharms Inc and is included in one NDA. There are eight patents protecting this drug.

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

The generic ingredient in ZURAMPIC is lesinurad. Additional details are available on the lesinurad profile page.

DrugPatentWatch^® Generic Entry Outlook for Zurampic

Zurampic was eligible for patent challenges on December 22, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 29, 2032. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ZURAMPIC

International Patents:	144
US Patents:	8
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	92
Patent Applications:	329
Drug Prices:	Drug price information for ZURAMPIC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZURAMPIC
DailyMed Link:	ZURAMPIC at DailyMed

See drug prices for ZURAMPIC

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

Constraining patent/regulatory exclusivity:

8,546,436

NDA:

207988

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 ZURAMPIC

ZURAMPIC is protected by eleven US patents.

This potential generic entry date is based on patent 8,546,436.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Expired US Patents for ZURAMPIC

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 ZURAMPIC

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 ZURAMPIC

When does loss-of-exclusivity occur for ZURAMPIC?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

New Zealand

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ZURAMPIC around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2374773
New Zealand	601786	Novel compounds and compositions and methods of use
Japan	4952943

Supplementary Protection Certificates for ZURAMPIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2135608	122016000060	Germany		PRODUCT NAME: LESINURAD ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1080 20160218
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	PA2019003	Lithuania		PRODUCT NAME: ALOPURINOLIS/LESINURADAS ARBA JO FRAMACINIU POZIURIU PRIIMTINA DRUSKA ARBA DRUSKOS; REGISTRATION NO/DATE: EU/1/18/1300 20180823

Market Dynamics and Financial Trajectory for Zurampic (Lesinurad)

Last updated: March 8, 2026

What Is Zurampic and Its Therapeutic Profile?

Zurampic (Lesinurad) is a uric acid reabsorption inhibitor approved by the U.S. Food and Drug Administration (FDA) in 2015 for combination therapy in the treatment of hyperuricemia associated with gout. It is designed to be used alongside xanthine oxidase inhibitors, such as allopurinol or febuxostat, to enhance uric acid excretion.

The drug's mechanism involves inhibiting URAT1 and OAT4 transporters, reducing serum uric acid levels more efficiently than monotherapy. It is marketed by Horizon Therapeutics, a relatively small biotech with a focus on niche indications. Zurampic's patent protection lasted until 2025, with potential exclusivity extensions permissible under certain regulatory frameworks.

Market Size and Growth Drivers

The global gout drug market, estimated at USD 2.3 billion in 2021, is projected to reach USD 2.9 billion by 2028, growing at a CAGR of approximately 3.4% (Research and Markets, 2022)[1]. Zurampic's addressable market includes patients inadequately controlled by xanthine oxidase inhibitors alone—estimated at 30% of gout patients, roughly 4 million worldwide.

Key factors driving growth include:

• Increasing prevalence of gout: Affects 1-2% of the adult population, with rising incidence linked to aging populations and obesity.
• Inadequate control with existing therapies: Up to 70% of patients do not achieve target serum uric acid levels with monotherapy.
• Expanding clinical guidelines: Recommending combination therapy for refractory cases.
• Enhanced awareness and diagnosis: Improved identification of hyperuricemia.

Competitive Landscape

Zurampic competes primarily with other urate-lowering therapies (ULTs):

Drug Class	Examples	Market Share (2022)	Patent/Exclusivity Status
Xanthine oxidase inhibitors	Allopurinol, Febuxostat	65%	Patent expired for allopurinol, febuxostat faces patent expiry around 2028
Uricosuric agents	Probenecid	10%	Generic availability
Recombinant uricase	Pegloticase	5%	Patent protections remaining; high cost
Lesinurad (Zurampic)	Horizon Therapeutics	Approximately 4-5% (estimated)	Patent until 2025; potential for extension

Market penetration remains limited for Zurampic, partly due to off-label use of monotherapy and safety concerns such as renal adverse effects.

Financial Performance and Revenue Trends

Horizon Therapeutics did not disclose specific sales figures for Zurampic post-2019, but estimates suggest peak global revenues in the USD 50-60 million range in 2017-2018. Patent expiration and competition from generics exert pressure on sales.

Factors influencing financial trajectories include:

• Patent expiry in 2025 limits further revenue growth unless protections are extended.
• Uptake depends on clinician acceptance, particularly given the safety profile.
• Market shifts favor monotherapy and newer therapies with better safety data.

The company’s focus shifted toward other pipeline candidates and existing blockbuster drugs, such as Tepezza (for thyroid eye disease), which recorded USD 1.1 billion in 2022 revenue[2].

Regulatory and Policy Environment

Regulatory bodies focus on safety and efficacy for gout medications:

• FDA approved Zurampic based on phase III trial data demonstrating serum uric acid lowering in combination with xanthine oxidase inhibitors.
• Safety concerns over renal adverse events prompted warnings and restricted use.
• European regulators did not approve Zurampic; alternative therapies dominate in European markets.

Policy trends favor personalized medicine, with courts scrutinizing drug safety, potentially impacting future approval or extension efforts.

Market Entry and Expansion Opportunities

Potential growth avenues include:

• Label expansion for monotherapy (pending new safety data).
• Use in additional populations, such as patients with renal impairment.
• Combination with emerging uric acid-lowering agents.

Conversely, lack of data on long-term safety and competition from novel agents may hinder expansion.

Financial Outlook and Key Risks

• Patent expiration in 2025 risks sharp revenue decline unless Horizon secures extensions or new formulations.
• Safety profile concerns may influence clinician prescribing habits.
• Competition from generic drugs, especially allopurinol and febuxostat, continues to erode market share.

A conservative financial outlook suggests Zurampic's revenues will decline by at least 50% post-patent expiry unless new indications or formulations emerge.

Key Takeaways

• Zurampic is a niche urate-lowering adjunct, with limited revenue potential beyond 2025 due to patent expiration.
• The gout therapy market remains competitive, dominated by generics and more established therapies.
• Growth hinges on label expansions, new safety data, and market acceptance of combination therapy.
• Horizon's broader pipeline and strategic priorities influence resource allocation toward Zurampic’s future prospects.

Frequently Asked Questions

1. What is the primary mechanism of Zurampic?
Zurampic inhibits URAT1 and OAT4 transporters, increasing uric acid excretion, thus lowering serum uric acid levels, especially when combined with xanthine oxidase inhibitors.

2. When does Zurampic's patent protection expire?
The patent protection is set to expire in 2025, with potential for regulatory or patent extensions.

3. How does Zurampic compare to other ULTs?
It is primarily used as an adjunct in refractory cases. Its market share remains limited due to safety concerns and competition from well-established generic therapies.

4. What are the key risks to Zurampic’s financial trajectory?
Patent expiry in 2025, safety profile concerns, and rising competition from generics threaten revenue streams.

5. Are there plans to expand Zurampic’s indications?
No official announcements; potential hinges on future clinical data and regulatory decisions focused on safety and monotherapy use.

---

References

[1] Research and Markets. (2022). Global Gout Treatment Market Analysis.

[2] Horizon Therapeutics. (2023). Annual Report.