FEBUXOSTAT - Generic Drug Details

What are the generic drug sources for febuxostat and what is the scope of patent protection?

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

Febuxostat has twenty-eight patent family members in fifteen countries.

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

Summary for FEBUXOSTAT

International Patents:	28
US Patents:	3
Tradenames:	2
Applicants:	16
NDAs:	16
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	139
Clinical Trials:	88
Patent Applications:	1,309
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
Jiangsu HengRui Medicine Co., Ltd.	Phase 3
JW Pharmaceutical	Phase 3
Chinese University of Hong Kong	Phase 2

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
Macleods Pharms Ltd	FEBUXOSTAT	febuxostat	TABLET;ORAL	207293-001	Sep 28, 2023	AB	RX	No	No
Lupin Ltd	FEBUXOSTAT	febuxostat	TABLET;ORAL	205406-002	Jan 17, 2024		DISCN	No	No
Alkem Labs Ltd	FEBUXOSTAT	febuxostat	TABLET;ORAL	212924-002	Dec 7, 2021	AB	RX	No	No
Prinston Inc	FEBUXOSTAT	febuxostat	TABLET;ORAL	206266-001	Mar 28, 2022	AB	RX	No	No
Lupin Ltd	FEBUXOSTAT	febuxostat	TABLET;ORAL	205406-001	Jan 17, 2024		DISCN	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
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-001	Feb 13, 2009
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-002	Feb 13, 2009
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-001	Feb 13, 2009
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-001	Feb 13, 2009

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/004773 Febuxostat 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/004374 Febuxostat 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/000777 80 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
Japan	WO2003082279	単一の結晶形を含有する固形製剤
Japan	4084309
Australia	2011299153	Methods for concomitant treatment of theophylline and febuxostat
Spain	2505690
Portugal	1488790

Supplementary Protection Certificates for FEBUXOSTAT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1020454	SPC/GB10/019	United Kingdom		SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB10/019 GRANTED TO TEIJIN LIMITED IN RESPECT OF THE PRODUCT FEBUXOSTAT, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6408 DATED 14/03/2012 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 22/04/2023.
1020454	19/2010	Austria		PRODUCT NAME: FEBUXOSTAT IN DER KRISTALLFORM A; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421
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
1488790	C20140037 00152	Estonia		PRODUCT NAME: FEBUKSOSTAAT;REG NO/DATE: EU/1/08/447 23.04.2008

FEBUXOSTAT Market Analysis and Financial Projection Experimental

Febuxostat Market Dynamics and Financial Trajectory

Market Overview

The febuxostat market is experiencing significant growth, driven by several key factors. Febuxostat, a non-purine xanthine oxidase inhibitor, is used to treat hyperuricemia in gout patients, particularly those who are intolerant or unresponsive to allopurinol[5].

Market Drivers

• Increasing Prevalence of Gout and Hyperuricemia: The rising incidence of gout and associated lifestyle diseases, such as obesity and dietary habits, is a major driver for the febuxostat market. This trend is particularly pronounced in regions with growing middle-class populations and aging demographics[2][4].
• Aging Populations: The increasing geriatric population globally contributes to a higher incidence of age-related diseases like gout, expanding the consumer base for febuxostat[2][4].
• Advances in Pharmaceutical Formulations: Innovations in drug formulations, such as the development of stable tablets with extended shelf life, enhance the market's growth prospects[1][2].
• Growing Awareness and Healthcare Infrastructure: Improved patient awareness about gout and its complications, coupled with better healthcare infrastructure in emerging economies, has led to higher diagnosis and treatment rates[2].

Market Restraints

• Regulatory Scrutiny: Potential cardiovascular risks associated with febuxostat have led to regulatory scrutiny, which can limit approval and prescription preferences. This scrutiny may delay market entry for new formulations and uses of febuxostat[1][2].
• Side Effects and Safety Concerns: Febuxostat has been linked to severe side effects, including liver issues and increased risk of heart-related problems, which could hinder its adoption compared to other treatments[2][5].
• Availability of Alternative Therapies: The presence of alternative drugs like allopurinol and the entry of generic versions of febuxostat can pose competitive pressure and challenge market growth[1][2].

Market Opportunities

• Geographical Expansion: Expanding into emerging markets where lifestyle shifts are increasing gout incidences offers significant opportunities for growth. Regions such as Asia-Pacific, with its growing middle-class population and improving healthcare infrastructure, are particularly promising[1][4].
• Partnerships and Patient Education: Collaborations with healthcare providers for patient education can enhance market penetration and improve treatment adherence[1].
• Research and Development: Investments in R&D to develop improved formulations of febuxostat, such as combination therapies and innovative dosage forms, can open new market segments and improve treatment outcomes[1][2].

Market Segmentation

• Formulation: The market is segmented into capsules and tablets, with tablets being a dominant form due to their stability and extended shelf life[1][2].
• Application: Febuxostat is primarily used for chronic gout management and treating uric acid-related conditions. Exploring other uses in metabolic and kidney diseases could expand its market[1][2].
• Distribution Channel: The market is segmented into offline channels (hospital pharmacies, retail pharmacies) and online platforms. The wide penetration of febuxostat through eCommerce platforms is a notable trend[1][2].

Regional Insights

• Americas: North America dominates the febuxostat market due to the presence of major key players, high disposable income, and well-developed healthcare infrastructure. Countries like the United States, Canada, and Brazil are key markets in this region[2][4].
• Asia-Pacific: This region is expected to grow significantly due to increasing research and development activities, improvements in healthcare infrastructure, and growing government support. Countries such as Japan, China, and India are driving this growth[2][4].
• Europe, Middle East & Africa: Europe has a substantial market share, with countries like Germany, France, and the UK being major contributors. The Middle East and Africa are also seeing growth, driven by rising healthcare expenditure and government initiatives[1][4].

Competitive Landscape

The febuxostat market is moderately competitive, with several key players such as Takeda Pharmaceutical Company Limited, Lupin Limited, Sun Pharmaceutical Industries Ltd., Alembic Pharmaceuticals Limited, and Zydus Lifesciences. Recent developments include FDA approvals for generic versions of febuxostat by companies like Lupin and Zydus Lifesciences, which are expanding treatment options for gout patients[1][2][4].

Financial Trajectory

• Current Market Size: The febuxostat market size was estimated at USD 953.01 million in 2023 and is expected to reach USD 1,033.83 million in 2024[2].
• Forecasted Growth: The market is projected to grow at a CAGR of 8.61% to reach USD 1,699.92 million by 2030. Another forecast suggests a CAGR of 7.9% to reach USD 1,662.16 million by 2029[2][4].
• Revenue Projections: The growth is driven by increasing demand, expanding geographical reach, and innovations in drug formulations. The market is expected to continue its upward trajectory, driven by the rising incidence of gout and the aging population[2][4].

Key Statistics

• Base Year [2023]: USD 953.01 million
• Estimated Year [2024]: USD 1,033.83 million
• Forecast Year [2030]: USD 1,699.92 million
• CAGR (%): 8.61%[2]

Challenges and Future Directions

Despite the growth prospects, the febuxostat market faces challenges such as regulatory scrutiny and the availability of alternative therapies. To mitigate these, future research and development should focus on enhancing drug safety profiles, exploring combination therapies, and improving patient adherence through innovative formulations. Emphasis on real-world evidence and long-term efficacy studies is crucial to support market positioning and physician confidence in prescribing febuxostat[1][2].

"Febuxostat was more effective than allopurinol in the subset with impaired renal function; no dose adjustment is required in mild-to-moderate renal impairment. Long-term extension studies confirmed the efficacy and tolerability of febuxostat." - N. Lawrence Edwards, *Rheumatology*, Volume 48, Issue suppl_2, May 2009[5].

Key Takeaways

• The febuxostat market is driven by the increasing prevalence of gout, aging populations, and advances in pharmaceutical formulations.
• Regulatory scrutiny and side effects are significant restraints.
• Geographical expansion, partnerships, and R&D investments offer substantial opportunities.
• The market is segmented by formulation, application, and distribution channel.
• North America and Asia-Pacific are key regions driving market growth.
• The market is expected to grow at a CAGR of 8.61% to reach USD 1,699.92 million by 2030.

Frequently Asked Questions (FAQs)

Q: What is the primary use of febuxostat? A: Febuxostat is primarily used to treat hyperuricemia in gout patients, especially those who are intolerant or unresponsive to allopurinol.

Q: What are the key drivers of the febuxostat market? A: The key drivers include the increasing prevalence of gout, aging populations, and advances in pharmaceutical formulations.

Q: Which regions are expected to drive the growth of the febuxostat market? A: North America and Asia-Pacific are expected to be the key regions driving market growth due to their well-developed healthcare infrastructure and growing middle-class populations.

Q: What are the major challenges facing the febuxostat market? A: The market faces challenges such as regulatory scrutiny over potential cardiovascular risks, side effects, and the availability of alternative therapies.

Q: How is the competitive landscape of the febuxostat market? A: The market is moderately competitive with several key players, including Takeda Pharmaceutical Company Limited, Lupin Limited, and Zydus Lifesciences.

Sources Cited

1. Research and Markets, "Febuxostat Market Size, Competitors & Forecast to 2030".
2. 360iResearch, "Febuxostat Market by Formulation, Application, Distribution Channel".
3. News Channel Nebraska, "Febuxostat Market Dynamics till 2032 | Growth Drivers, Market Constraints and Challenges".
4. Data Bridge Market Research, "Global Febuxostat Market - Industry Trends and Forecast to 2029".
5. N. Lawrence Edwards, "Febuxostat: a new treatment for hyperuricaemia in gout", Rheumatology, Volume 48, Issue suppl_2, May 2009.