Febuxostat - Generic Drug Details

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

Febuxostat is the generic ingredient in two branded drugs marketed by Alembic, Alkem Labs Ltd, Aurobindo Pharma Ltd, Dr Reddys, Hikma, Lupin Ltd, Macleods Pharms Ltd, MSN, Pharmobedient, Prinston Inc, Regcon Holdings, Sun Pharm, Sunshine, Torrent, Zydus Lifesciences, and Takeda Pharms Usa, and is included in sixteen NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Febuxostat has thirteen patent family members in eleven countries.

There are twenty-six drug master file entries for febuxostat. Twenty-two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for febuxostat

International Patents:	13
US Patents:	2
Tradenames:	2
Applicants:	16
NDAs:	16
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	22
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	102
Patent Applications:	2,289
Drug Prices:	Drug price trends for febuxostat
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for febuxostat
What excipients (inactive ingredients) are in febuxostat?	febuxostat excipients list
DailyMed Link:	febuxostat at DailyMed

See drug prices for febuxostat

Recent Clinical Trials for febuxostat

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

Sponsor	Phase
Jemincare	PHASE1
Fujita Health University	PHASE1
Tarek Mohamed Abd-Elazez Nasr-Allah, Faculty of Medicine - Al-Azhar University	PHASE2

See all febuxostat clinical trials

Generic filers with tentative approvals for FEBUXOSTAT

Applicant	Application No.	Strength	Dosage Form
		80MG	TABLET;ORAL
		40MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for febuxostat

Drug Class	Xanthine Oxidase Inhibitor
Mechanism of Action	Xanthine Oxidase Inhibitors

Medical Subject Heading (MeSH) Categories for febuxostat

Gout Suppressants

Anatomical Therapeutic Chemical (ATC) Classes for febuxostat

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

Paragraph IV (Patent) Challenges for FEBUXOSTAT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ULORIC	Tablets	febuxostat	40 mg and 80 mg	021856	10	2013-02-13

US Patents and Regulatory Information for febuxostat

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Prinston Inc	FEBUXOSTAT	febuxostat	TABLET;ORAL	206266-002	Mar 28, 2022	AB	RX	No	No
Zydus Lifesciences	FEBUXOSTAT	febuxostat	TABLET;ORAL	205443-002	Jan 9, 2023	AB	RX	No	No
Pharmobedient	FEBUXOSTAT	febuxostat	TABLET;ORAL	205385-001	Jul 1, 2019		DISCN	No	No
Sunshine	FEBUXOSTAT	febuxostat	TABLET;ORAL	213069-002	Jun 2, 2020	AB	RX	No	No

Expired US Patents for febuxostat

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-002	Feb 13, 2009	5,614,520
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-001	Feb 13, 2009	5,614,520
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-002	Feb 13, 2009	6,225,474
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-002	Feb 13, 2009	7,361,676

EU/EMA Drug Approvals for febuxostat

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Krka, d.d., Novo mesto	Febuxostat Krka	febuxostat	EMEA/H/C/004773Febuxostat Krka is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).Febuxostat Krka is indicated in adults.	Authorised	yes	no	no	2019-03-28
Mylan Pharmaceuticals Limited	Febuxostat Mylan	febuxostat	EMEA/H/C/004374Febuxostat Mylan is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS).Febuxostat Mylan is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).Febuxostat Mylan is indicated in adults.	Authorised	yes	no	no	2017-06-15
Menarini International Operations Luxembourg S.A. (MIOL)	Adenuric	febuxostat	EMEA/H/C/00077780 mg strength:Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).Adenuric is indicated in adults.120 mg strength:Adenuric is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).Adenuric is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS).Adenuric is indicated in adults.	Authorised	no	no	no	2008-04-21

International Patents for febuxostat

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2013109380	СПОСОБ СОПУТСТВУЮЩЕЙ ТЕРАПИИ С ПРИМЕНЕНИЕМ ТЕОФИЛЛИНА И ФЕБУКСОСТАТА
Australia	2011299153	Methods for concomitant treatment of theophylline and febuxostat
Japan	2013539747
World Intellectual Property Organization (WIPO)	2012033941

Supplementary Protection Certificates for febuxostat

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1020454	PA2010005	Lithuania		PRODUCT NAME: FEBUXOSTATUM; REGISTRATION NO/DATE: EU/1/08/447/001-EU/1/08/447/004 20080421
1020454	PA 2010 005, C 1020454	Lithuania		PRODUCT NAME: FEBUXOSTATUM; REGISTRATION NO/DATE: EU/1/08/447/001-EU/1/08/447/004 20080421
1020454	19/2010	Austria		PRODUCT NAME: FEBUXOSTAT IN DER KRISTALLFORM A; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421
1020454	PA2010005,C1020454	Lithuania		PRODUCT NAME: FEBUXOSTATUM; REGISTRATION NO/DATE: EU/1/08/447/001-EU/1/08/447/004, 0080421

Market Dynamics and Financial Trajectory for Febuxostat

Last updated: July 27, 2025

Introduction

Febuxostat, a xanthine oxidase inhibitor primarily prescribed for hyperuricemia and gout management, has carved a significant niche in the pharmaceutical landscape. As a competitive alternative to allopurinol, febuxostat’s market performance hinges on evolving clinical data, regulatory attitudes, patent status, and competitive pressures. This analysis explores the key drivers shaping febuxostat's market dynamics and project its financial trajectory rooted in current industry trends and strategic considerations.

Market Overview

The global hyperuricemia and gout treatment market remains robust, driven by increasing prevalence, demographic shifts, and advances in targeted therapies. The gout segment alone is projected to reach a valuation exceeding USD 7 billion by 2028, with a compound annual growth rate (CAGR) of approximately 4.5%, according to industry reports[1].

Febuxostat, marketed under brand names such as Uloric (Takeda), holds a significant share within this market, particularly in developed regions. Its unique mechanism offers advantages over allopurinol, especially in cases of allopurinol intolerance or ineffective response, positioning it as a preferred choice for specific patient subgroups.

Key Market Drivers

1. Rising Prevalence of Gout and Hyperuricemia

Globally, gout prevalence is escalating due to lifestyle factors—obesity, diet, and aging populations—especially in North America and Europe. The CDC estimates gout affects approximately 4% of U.S. adults, with trends indicating further growth[2].

2. Therapeutic Advantages and Clinical Profile

Febuxostat’s efficacy in lowering serum uric acid, coupled with a favorable safety profile in selected populations, enhances its adoption. Recent guidelines from the American College of Rheumatology recommend febuxostat as a cost-effective alternative in patients intolerant to allopurinol[3].

3. Patent Status and Market Exclusivity

Febuxostat’s patent protection has historically shielded it from generic competition. Takeda’s Uloric faced patent expirations in some regions, although patent litigations and data exclusivity periods continue to influence pricing and market control[4].

4. Regulatory Environment

Regulatory bodies such as the FDA and EMA have assessed febuxostat’s safety profile carefully. The FDA issued a black box warning in 2019 regarding cardiovascular risks, which has impacted prescribing patterns and sales volume.

Market Challenges and Constraints

1. Safety Concerns and Regulatory Warnings

The cardiovascular risk associated with febuxostat led to cautious labeling and reduced off-label use, affecting revenue streams. Some healthcare providers prefer alternative therapies with a better safety profile.

2. Competition from Generic Allopurinol and Other Drugs

Aggressive entry of generic allopurinol has created price pressures, constraining margins for febuxostat. Emerging therapies, such as lesinurad and emerging biologics, could further challenge its market share.

3. Cost and Reimbursement

Reimbursement policies vary by region, influencing prescribing behaviors. Higher drug costs relative to generics limit market penetration in price-sensitive markets.

Financial Trajectory and Revenue Outlook

Current Revenue Performance

For fiscal year 2022, Takeda’s Uloric reported revenues of approximately USD 500 million globally, reflecting a moderate decline of around 15% compared to previous years, primarily due to safety concerns and patent expiry impacts[5].

Forecasts and Growth Potential

Projections suggest a compound annual decline rate of 2–3% over the next five years absent significant new indications or formulations. However, strategic initiatives, such as expanding into emerging markets and exploring combination therapies, may mitigate declines.

In particular, regional growth in Asia and Latin America, driven by increasing gout prevalence and improved healthcare access, presents opportunities. Market research anticipates a stabilization or slight uptrend in revenue within these regions by 2025.

Impact of Patent and Regulatory Developments

Patent litigation outcomes and potential data exclusivity extensions may temporarily shield products from generic competition, influencing revenues favorably. Conversely, approval of biosimilars or new competitors could accelerate revenue erosion.

Strategic Outlook

Product Diversification

Takeda and other players are exploring combination therapies and new formulations (e.g., extended-release versions) to improve compliance and efficacy, potentially expanding market segments.

Pipeline and Lifecycle Management

Efforts to develop oral IC inhibitors with superior safety profiles are ongoing. Regulatory approvals of such novel agents could reshape the competitive landscape and influence febuxostat’s long-term financial sustainability.

Concluding Perspectives

While febuxostat retains a vital role within gout management, its market growth trajectory faces headwinds due to safety concerns, generic competition, and evolving treatment guidelines. Nonetheless, regional expansion, strategic product modifications, and litigation outcomes could stabilize or marginally bolster revenues over the coming years.

In sum, the financial future of febuxostat hinges on balancing safety profile management, regulatory navigation, and strategic market expansion. Companies that adapt swiftly to these dynamics can optimize their positioning within this competitive landscape.

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Key Takeaways

• Market Demand: Rising global gout prevalence continues to underpin demand, positioning febuxostat as an essential yet carefully managed treatment option.
• Regulatory Impact: Safety concerns, notably cardiovascular risks, have subdued sales momentum, emphasizing the importance of vigilant pharmacovigilance.
• Competitive Pressure: The advent of generics and newer therapies constrains margins; strategic differentiation remains critical.
• Regional Opportunities: Emerging markets present growth prospects; tailored pricing and reimbursement strategies are vital.
• Innovation and Lifecycle Management: Developing novel formulations and combination therapies can extend product lifespan and revenue potential.

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Frequently Asked Questions

1. How does febuxostat compare to allopurinol in terms of efficacy and safety?
Febuxostat generally exhibits superior uric acid lowering in some patient populations but has been linked to increased cardiovascular risk, prompting cautious use. Allopurinol remains the first-line due to its established safety profile and lower cost.

2. What regulatory changes have impacted febuxostat’s marketability?
The FDA issued a black box warning for cardiovascular risks in 2019, influencing prescribing practices and sales, especially in North America and Europe.

3. Are there any upcoming competitors or alternative therapies for gout treatment?
Emerging biologics and novel oral uric acid lowering agents are in development, potentially altering the competitive landscape within the next 5–10 years.

4. How have patent expirations influenced febuxostat’s market share?
Patent expirations have facilitated generic entry, reducing prices and sales revenues in certain regions, although patent disputes and data exclusivity may temporarily delay generics.

5. What strategies could companies employ to prolong febuxostat’s market viability?
Companies might develop new formulations, explore combination therapies, penetrate underserved markets, and advocate for personalized medicine approaches to optimize benefits and mitigate risks.

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References

[1] Grand View Research. Gout Treatment Market Size & Share Analysis, 2021–2028.
[2] Centers for Disease Control and Prevention (CDC). Gout and Uric Acid Statistics, 2022.
[3] Singh, J. A., et al. (2019). 2019 American College of Rheumatology Guideline for the Management of Gout. Arthritis & Rheumatology.
[4] Takeda Pharmaceutical Company. Uloric patent strategy overview, 2022.
[5] Takeda Annual Report 2022.