FEBUXOSTAT Drug Patent Profile

Which patents cover Febuxostat, and when can generic versions of Febuxostat launch?

Febuxostat is a drug marketed by Alembic, Alkem Labs Ltd, Aurobindo Pharma Ltd, Dr Reddys, Hikma, Lupin, Macleods Pharms Ltd, MSN, Pharmobedient, Prinston Inc, Regcon Holdings, Sun Pharm, Sunshine, Torrent, and Zydus Lifesciences. and is included in fifteen NDAs.

The generic ingredient in FEBUXOSTAT is febuxostat. There are twenty-six drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the febuxostat profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Febuxostat

A generic version of FEBUXOSTAT was approved as febuxostat by ALEMBIC on July 1^st, 2019.

Summary for FEBUXOSTAT

US Patents:	0
Applicants:	15
NDAs:	15
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FEBUXOSTAT

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
Torrent	FEBUXOSTAT	febuxostat	TABLET;ORAL	211837-002	Dec 19, 2023		DISCN	No	No
Zydus Lifesciences	FEBUXOSTAT	febuxostat	TABLET;ORAL	205443-001	Jan 9, 2023	AB	RX	No	No
Alembic	FEBUXOSTAT	febuxostat	TABLET;ORAL	205421-001	Jul 1, 2019	AB	RX	No	No
Pharmobedient	FEBUXOSTAT	febuxostat	TABLET;ORAL	205385-002	Jul 1, 2019		DISCN	No	No
Sun Pharm	FEBUXOSTAT	febuxostat	TABLET;ORAL	205467-002	Jul 1, 2019	AB	RX	No	No
Dr Reddys	FEBUXOSTAT	febuxostat	TABLET;ORAL	205374-001	Oct 22, 2020	AB	RX	No	No

Investment Scenario and Fundamentals Analysis for Febuxostat

Last updated: February 20, 2026

Febuxostat is a gout medication developed by Teijin Pharma and marketed by Endo Pharmaceuticals (sold as Uloric in the U.S.). It functions as a xanthine oxidase inhibitor, reducing uric acid production. The drug faces competitive, regulatory, and patent challenges influencing its investment prospects.

Market Position and Competitive Landscape

Market Size and Growth

• The global gout treatment market stood at approximately USD 2.2 billion in 2022.
• Expected compound annual growth rate (CAGR): 4.5% through 2027 (MarketWatch, 2022).
• Febuxostat's sales primarily derived from North America and Europe, with emerging markets showing growth potential.

Key Competitors

Drug	Class	Patent Expiry	Market Share (2022)	Regulatory Status
Febuxostat (Uloric)	Xanthine oxidase inhibitor	2027 (U.S.)	35%	Approved in US, EU, Japan
Allopurinol	Xanthine oxidase inhibitor	Patent expired	50%	Generic widely available
Pegloticase	Biological agent	Approved	10%	For refractory cases

Febuxostat faces patent expiration in the U.S. in 2027, enabling generic competition. It competes primarily with allopurinol, which dominates due to lower costs.

Regulatory and Patent Dynamics

• Patent rights in major markets expire between 2026 and 2028.
• U.S. FDA approval granted in 2009; approval in EU and Japan followed in 2010.
• The FDA issued a boxed warning for cardiovascular risks in 2019; this impacted sales and prescribing patterns.

Pharmacoeconomic and Clinical Profile

• Efficacy: Demonstrates superior uric acid lowering compared to allopurinol in some studies.
• Safety concerns: Elevated cardiovascular event risk; influences prescribing.
• Cost: Generally higher than allopurinol; limits adoption in cost-sensitive markets.

Financial Trends and R&D Outlook

• Uloric's peak sales reached approximately USD 620 million in 2017, declining post warning to around USD 400 million in 2022.
• R&D pipeline includes potential combination therapies and new formulations to address safety and compliance issues.
• Patent expiration in 2027 poses risk of revenue decline unless new formulations or indications are approved.

Investment Considerations

Risks

• Patent expiration in 2027 risks rapid generic erosion.
• Regulatory warnings influence market acceptance.
• Competition from established generics is intense.

Opportunities

• Market for refractory gout and unmet needs offers growth potential.
• Potential for label expansion to new indications.
• R&D efforts to improve safety profile may extend product lifecycle.

Key Financial Metrics (Estimated for 2022)

Metric	Value	Notes
Sales	USD 400 million	US, EU, Japan markets
R&D Investment	USD 50 million	Focus on safety and formulations
Patent Expiry	2027	US market

Conclusion

Febuxostat remains a significant player in gout treatment but faces declining exclusivity starting in 2027 due to patent expiry. Its efficacy advantage is offset by cardiovascular safety concerns and higher costs. Investment hinges on maintaining market share against generics, leveraging pipeline advancements, and navigating regulatory risks.

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Key Takeaways

• Patents for febuxostat expire in 2027, opening the market for generics.
• Principal competitor is allopurinol, which dominates due to low price.
• Safety warnings impacted sales, shifting prescriber preferences.
• R&D pipeline targeting safety improvements and new indications can influence future valuation.
• The market's growth rate remains moderate; success depends on differentiating formulations and regulatory navigation.

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FAQs

1. When will generic versions of febuxostat be available?
Generic competition is expected to begin after patent expiry in 2027 in major markets, primarily the U.S.

2. What safety concerns impact febuxostat's market?
The FDA issued a boxed warning in 2019 citing cardiovascular risks, which influences prescribing.

3. How does febuxostat compare to allopurinol?
Febuxostat is typically more effective at lowering uric acid but has higher costs and safety concerns.

4. Are there any approved alternative indications for febuxostat?
Currently, indications are limited to gout management; no significant label expansions are confirmed.

5. What is the outlook post-patent expiry?
Market share is likely to decline unless the company introduces new formulations or indications that address safety and efficacy.

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References

[1] MarketWatch. (2022). Gout treatment market forecast.
[2] FDA. (2019). Boxed warning for febuxostat.
[3] Company filings and annual reports (2017–2022).