ULORIC Drug Patent Profile

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

Uloric is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has thirteen patent family members in eleven countries.

The generic ingredient in ULORIC 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 Uloric

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

Summary for ULORIC

International Patents:	13
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	27
Patent Applications:	1,214
Drug Prices:	Drug price information for ULORIC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ULORIC
What excipients (inactive ingredients) are in ULORIC?	ULORIC excipients list
DailyMed Link:	ULORIC at DailyMed

See drug prices for ULORIC

See drug sales revenues for ULORIC

Recent Clinical Trials for ULORIC

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

Sponsor	Phase
Ai Peng	N/A
Analytical Laboratory (Pharmacokinetic Sample Analysis): USA	Phase 2
AstraZeneca	Phase 2

See all ULORIC clinical trials

Pharmacology for ULORIC

Drug Class	Xanthine Oxidase Inhibitor
Mechanism of Action	Xanthine Oxidase Inhibitors

Paragraph IV (Patent) Challenges for ULORIC

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 ULORIC

ULORIC is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-001	Feb 13, 2009	AB	RX	Yes	No	9,107,912
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-002	Feb 13, 2009	AB	RX	Yes	Yes	9,107,912
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-001	Feb 13, 2009	AB	RX	Yes	No	8,372,872
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-002	Feb 13, 2009	AB	RX	Yes	Yes	8,372,872

Expired US Patents for ULORIC

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

EU/EMA Drug Approvals for ULORIC

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 ULORIC

See the table below for patents covering ULORIC around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	142494
Australia	645867
Australia	8952291
Canada	2073981	DERIVES DE 2-ARYLTHIAZOLE ET COMPOSITION PHARMACEUTIQUE A BASE DE CES DERIVES (2-ARYLTHIAZOLE DERIVATIVES AND PHARMACEUTICAL COMPOSITION THEREOF)
Germany	122008000051
Germany	69122084

Supplementary Protection Certificates for ULORIC

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	C300447	Netherlands		PRODUCT NAME: FEBUXOSTAT; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421
1020454	CA 2010 00015	Denmark
1020454	91682	Luxembourg		91682, EXPIRES: 20230421
1020454	SPC015/2010	Ireland		SPC015/2010: 20101001, EXPIRES: 20230420
1020454	PA2010005,C1020454	Lithuania		PRODUCT NAME: FEBUXOSTATUM; REGISTRATION NO/DATE: EU/1/08/447/001-EU/1/08/447/004, 0080421

Uloric (febuxostat) Market Dynamics and Financial Trajectory: Sales Trends, Exclusivity/Pipeline Risk, and Competitive Pressure

Last updated: June 24, 2026

Uloric (febuxostat) is a branded, chronic-gout drug that has faced multi-year volume pressure from generic febuxostat entry plus intensity shifts in cardiology safety scrutiny. The commercial trajectory in most markets is dominated by (1) time-phased patent/exclusivity expiry and (2) the extent and pace of generic adoption after loss of exclusivity, which typically compresses pricing and margins. Financial outcomes since generic launches have been driven more by competitive pricing mechanics than by incremental label expansion.

What is the market position of Uloric (febuxostat) in chronic gout therapy?

Answer: Uloric has historically competed in chronic gout and hyperuricemia, primarily against oral xanthine oxidase inhibitors (XOIs) such as allopurinol and other branded products where available. After generic febuxostat entry, Uloric’s position becomes largely a pricing and payer-contracting outcome, with safety-related prescriber behavior a second-order driver.

Which drug class does Uloric compete in, and how does that shape pricing power?

Uloric is an oral XOI that reduces serum urate by inhibiting xanthine oxidase. In this class, prescribers and payers often treat products as therapeutically substitutable within labeled indications. That substitution dynamic typically limits branded pricing power once generics are present, unless differentiation is supported by outcomes data adopted by guidelines, formularies, or payer policies.

What payer and formulary dynamics usually matter most for XOIs?

For chronic gout, the dominant market-shaping factors are:

• Step edits or prior authorization (PA) relative to allopurinol
• Quantity limits tied to urate targets
• Switching policies to lower-cost generics
• Safety-based prescribing guidance and cardiology risk flags

How have FDA and safety issues affected Uloric prescribing and revenue?

Answer: Uloric’s sales trajectory has been influenced by cardiology safety messaging and treatment behavior changes following FDA communications and guideline uptake. The impact shows up as reduced initiation and a higher share of patients staying on allopurinol or switching among XOIs.

What safety signals changed clinician behavior for febuxostat?

Regulatory communications following cardiovascular safety concerns translated into practice patterns where:

• Clinicians may prefer allopurinol first in broader patient populations
• Uloric use becomes more selective for patients intolerant to allopurinol or when clinical benefits outweigh perceived risk

Do safety communications create durable brand damage or only initiation friction?

In markets with generics, the dominant effect becomes reinforcement of generic uptake. Even where a prescriber prefers Uloric, payer policy and lower-cost alternatives usually shift the net outcome once febuxostat generics are available.

When does Uloric lose exclusivity and when do generics typically launch?

Answer: Uloric is no longer protected by broad, active exclusivity in the US for its core febuxostat API once generic entry has occurred. The market is now shaped by generic competitive cycles, label sustainability, and manufacturing/IP disputes that can delay or accelerate specific generic launches.

How do exclusivity timelines drive revenue shape?

Branded sales usually follow this pattern:

1. Pre-launch ramp down risk: payers anticipate lower-cost entry and prepare formulary changes.
2. Launch shock: price compression after first generic competitors enter.
3. Multi-competitor phase: margins and revenues decline further as additional generics enter.
4. Settling into a “brand premium” niche: brand retains a smaller share via prescriber preference, patient experience, or contracting.

What competitive landscape pressures affect Uloric pricing and volume?

Answer: The core competition is generics of febuxostat and branded or generic allopurinol. Once febuxostat becomes widely available, the brand competes on contracting terms and continuity of therapy rather than on unique pharmacology.

Generic febuxostat entry: what it does to the P&L

Generic entry compresses:

• Wholesale acquisition price and net price
• Gross margin via lower negotiated discounts and more aggressive payer rebates by competitors
• Reimbursement rates and pharmacy channel pricing

Allopurinol remains the structural competitor

Allopurinol is often the default first-line urate-lowering strategy in guidelines and payer pathways. Uloric’s incremental advantage is often framed for patients who cannot tolerate allopurinol, have inadequate response, or have specific clinical constraints.

What generic entry risks exist for Uloric and how do they change shareholder outlook?

Answer: The dominant risk after first generic launches is not new exclusivity challenges but “competitive overhang” from:

• Additional generic entrants eroding pricing further
• Launch sequencing differences by dosage form and strength
• Any remaining patent settlements or manufacturing/IP barriers that affect timing

How do companies typically hedge generic overhang?

Brands often respond via:

• Contracting and rebate restructuring
• Channel management and continuity programs
• Focus on patient retention rather than new initiations

What is the Orange Book status of Uloric (febuxostat) and how does it translate to exclusivity pressure?

Answer: Uloric’s Orange Book protection for febuxostat has expired sufficiently to enable generic competition in practice. The commercial reality is that the drug’s current market structure reflects post-exclusivity generic penetration rather than active brand-exclusive barriers.

What patent categories historically matter for gout drugs?

For XOIs like febuxostat, the patent estate tends to break into:

• Composition of matter (API)
• Formulation or specific crystallinity/polymorph claims
• Manufacturing process claims
• Method-of-use claims (less common as the core label aligns with urate lowering)

In post-expiry regimes, litigation around narrower formulation/process claims can still affect launch timing for specific generic submissions, but broad market outcomes remain price-driven.

How do formulation and method-of-use patents affect Uloric’s competitive differentiation?

Answer: Formulation differentiation can matter only if it is tied to payer or prescriber-visible outcomes (tolerability, adherence, dosing convenience). Method-of-use differentiation matters only if there are distinguishable clinical use cases not already covered by standard practice.

What matters more in real-world gout switching decisions?

In practice, switching depends more on:

• Patient tolerance history
• Uric acid target achievement and monitoring
• Payer policy constraints
• Cardiac safety counseling and clinician comfort

How strong is the patent estate for Uloric and what does it imply for sustained sales?

Answer: Uloric’s sustained sales, where they still exist, are not supported by ongoing broad exclusivity strength. The estate effect has largely transitioned into a generic-driven market with residual brand share.

What does “estate strength” mean commercially after exclusivity?

Even when some patents remain, they usually influence:

• Whether a subset of generics can launch at the same time
• Which label carve-outs a generic must adopt
• The availability of specific strengths or product designs

Net effect on brand revenue is often limited once multiple generics are established.

What are Uloric’s financial trajectory milestones since peak branded sales?

Answer: Uloric’s long-run financial trajectory tracks three phases:

• Branded peak period: premium pricing and differentiation
• Generic erosion: first generic entry leads to rapid net price and margin compression
• Post-erosion consolidation: brand maintains lower volume share, with revenue primarily dependent on contracting and continuity

What metrics best describe the trajectory in company financials?

The most decision-useful metrics are:

• Net sales by geography (US vs ex-US)
• Gross margin movement tied to rebate pressure
• Script share and pharmacy channel mix
• Payer coverage shifts after generic approvals
• Sales concentration by major accounts

Which companies are key competitors to Uloric in febuxostat and gout?

Answer: The competitor set is largely generic febuxostat manufacturers plus allopurinol brands/generics. After generic entry, the market becomes less about brand-versus-brand pharmacology and more about who can supply at lowest cost and win pharmacy contracts.

What do supplier dynamics mean for supply chain and contracting?

Generic producers with scale can offer stronger contracting terms and maintain market share. The brand’s negotiating leverage typically drops as more alternatives become available and as formularies align to lowest cost.

How does Uloric compare with allopurinol and other urate-lowering options commercially?

Answer: Uloric often represents a second-line option relative to allopurinol in routine prescribing. Commercially, that positions Uloric to lose incremental volume when prescriber behavior shifts toward first-line allopurinol or when payers tighten step therapy.

What label positioning usually changes market outcomes?

If clinical guidance favors allopurinol first, then Uloric benefits from the “intolerance” or “inadequate response” pool. Safety messaging can shrink that pool further, especially if prescribers interpret risk conservatively.

What does Uloric’s trajectory imply for investors and licensing partners?

Answer: The investment case in Uloric is primarily tied to defensibility against generic price erosion and to residual brand premium through contracting. For licensing or partnering, the commercial ceiling after exclusivity is typically driven by generic intensity, not by patent durability.

Where deal logic usually focuses post-generic entry

• Contracting economics: rebate and net price modeling versus generic pricing curves
• Product differentiation claims and whether payers honor them
• Geography-specific penetration, where some markets may have lagged generic adoption

Key Takeaways

• Uloric’s market dynamics are dominated by generic febuxostat penetration and payer-driven substitution once exclusivity ended.
• Safety-related cardiology messaging has influenced prescribing patterns, reinforcing constraints on initiation and shifting patients toward allopurinol.
• The post-exclusivity financial trajectory typically follows a fast net-price compression phase after initial generic entry, followed by slower consolidation as additional competitors enter.
• Patent estate effects after exclusivity can delay specific launches, but broad revenue trajectory is largely price- and contracting-driven.

FAQs

1. Does Uloric still have meaningful differentiated use cases versus allopurinol after generics?
2. How do payer step edits for gout typically affect febuxostat branded and generic demand?
3. Do cardiovascular safety communications change long-term retention versus switching outcomes for febuxostat?
4. Which factors determine how quickly branded gout sales collapse after generic febuxostat launches?
5. What commercial signals indicate that additional generic entrants will further compress Uloric net prices?

References

1. U.S. Food and Drug Administration. Drug Safety Communications and labeling information for febuxostat (Uloric). FDA.
2. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations for febuxostat (Uloric). FDA.
3. American College of Rheumatology guideline documents and updates addressing urate-lowering therapy selection for gout. (Most recent available guideline versions prior to 2024).
4. Clinical guideline and evidence summaries on cardiovascular risk considerations for febuxostat in gout populations. (Peer-reviewed sources and society publications).

DrugChatter Q&A for ULORIC

Can uloric cause heart problems?