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-two 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:	1,260
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
PAREXEL Early Phase Clinical Unit Baltimore	Phase 2
Covance Bioanalytical Services, LLC	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	021856-002	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
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-001	Feb 13, 2009	7,361,676

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
World Intellectual Property Organization (WIPO)	9209279
Brazil	112013005792	método para o tratamento concomitante de teofilina e febuxostat
Portugal	1020454
Japan	4084309
Spain	2532210

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	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
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	CR 2010 00015	Denmark		PRODUCT NAME: FEBUXOSTAT; REG. NO/DATE: EU/1/08/447/001-004 20080421

Market Dynamics and Financial Trajectory for ULORIC (Ulotaront)

Last updated: July 27, 2025

Introduction

ULORIC (ulotaront), developed by Sunovion Pharmaceuticals, is an investigational drug initially positioned as a novel treatment for schizophrenia and related psychiatric disorders. With a unique mechanism targeting trace amine-associated receptor 1 (TAAR1), ULORIC has garnered strategic interest due to its potential to address unmet needs within the neuropsychiatric landscape. This analysis explores the evolving market dynamics and projected financial trajectory of ULORIC, considering clinical developments, competitive positioning, regulatory pathways, and commercial potential.

Market Landscape and Therapeutic Significance

Schizophrenia affects approximately 20 million individuals globally, with existing treatments primarily comprising dopamine receptor antagonists. While effective for some, these therapies often cause adverse effects, including weight gain, metabolic disturbances, and extrapyramidal symptoms. As such, there is a substantial market demand for novel agents with improved safety profiles and efficacy.

ULORIC’s target niche positions it as a potentially significant entrant within an innovative class of psychiatric medicines. Its mechanism—modulating TAAR1—differs fundamentally from traditional dopaminergic approaches, offering a potential for better tolerability and symptom control. Currently, the drug is in late-stage clinical trials, with regulatory filings anticipated pending successful trial outcomes.

Clinical and Regulatory Milestones

ULORIC's development has largely centered on Phase 2 and Phase 3 studies to evaluate efficacy, safety, and tolerability for schizophrenia and mood disorders. Preliminary data demonstrate promising antipsychotic activity with a favorable side effect profile, especially concerning metabolic parameters.

Regulatory status: As of early 2023, Sunovion is preparing for New Drug Application (NDA) submission, with regulatory bodies such as the FDA and EMA closely monitoring trial data. A positive approval trajectory hinges on demonstrating significant clinical benefit over existing therapies, especially in terms of symptom reduction and metabolic safety.

Competitive Dynamics

ULORIC enters a competitive landscape featuring several established antipsychotics and emerging therapies:

• Conventional Antipsychotics: Risperidone, olanzapine, and haloperidol dominate, but often with side effects.
• Atypical Antipsychotics: Clozapine, quetiapine, brexpiprazole, and cariprazine offer varying efficacy and tolerability profiles.
• Innovative Agents: Drug candidates like brexpiprazole and lumateperone target similar populations with unique mechanisms, highlighting a crowded market resistant to pharmacological innovation.

ULORIC's distinct mechanism provides a competitive edge, emphasizing its potential as a differentiated treatment option—especially if clinical data confirm superior tolerability and efficacy.

Market Penetration and Adoption Potential

The success of ULORIC hinges on multiple factors:

• Regulatory approval: Efficacy demonstrated in Phase 3 trials will be decisive.
• Pricing strategy: Competitive pricing will influence adoption amid existing therapies.
• Physician acceptance: Education and clinical guidelines will shape prescribing behaviors.
• Reimbursement landscape: Reimbursement decisions by payers will impact market penetration.

Given the high unmet need in treatment-resistant schizophrenia and the demand for safer medications, ULORIC’s market penetration could be significant within 3-5 years post-approval, assuming it demonstrates clinical advantages.

Financial Trajectory and Revenue Outlook

Revenue Projections

Based on current clinical data and market analysis, ULORIC's initial approval could generate revenue in the range of $200-$300 million annually within the first three years if prescriber adoption ramps up as anticipated.

• Market penetration assumptions: An initial market share of 10-15% in schizophrenia therapy.
• Pricing assumptions: A premium pricing tier, reflecting its novel mechanism and safety benefits.

Growth Drivers

• Pipeline expansion: Potential investigational uses in bipolar disorder and depression could broaden revenue streams.
• Global expansion: European, Asian, and other international markets represent significant future upside.
• Competitive advantage: Favorable safety profile may facilitate higher dosage adherence, boosting long-term sales.

Risks and Challenges

• Regulatory delays: Unanticipated hurdles could impact time-to-market.
• Competitive innovations: Emergence of alternative therapies could limit market share.
• Clinical trial outcomes: Any safety concerns or lack of efficacy could diminish commercial prospects.

Long-term Outlook

If ULORIC secures regulatory approval and establishes a strong foothold, its cumulative global sales could approach $1 billion annually within 7-10 years. Conversely, delayed or unsuccessful approval could truncate or dramatically reduce its market impact.

Strategic Implications for Stakeholders

Investors should monitor clinical trial progress, regulatory developments, and competitive dynamics closely. Pharma companies need to develop targeted marketing strategies emphasizing ULORIC's differentiated profile. Payers and healthcare providers will assess cost-effectiveness and safety data before incentivizing uptake.

Key Takeaways

• Innovative mechanism: ULORIC's TAAR1 modulation offers a promising alternative in an established therapeutic space dominated by dopamine antagonists.
• Regulatory trajectory: Pending positive Phase 3 trial results, ULORIC’s approval could materially influence the psychiatric treatment landscape.
• Market potential: The global schizophrenia market presents a multi-billion dollar opportunity, with ULORIC positioned to capture a meaningful share if clinical and regulatory hurdles are surmounted.
• Competitive positioning: Its differentiated mechanism could provide a sustainable advantage against existing and emerging competitors.
• Growth prospects: Successful launches in initial markets, coupled with pipeline expansion, could yield long-term revenue streams exceeding $1 billion annually.

Conclusion

ULORIC stands at a critical juncture, with its future financial trajectory heavily reliant on clinical validation, regulatory approval, and strategic commercialization. Its potential to address unmet needs in neuropsychiatry positions it as a noteworthy candidate for significant market impact, particularly if it achieves its promise of improved safety and efficacy.

FAQs

1. When is ULORIC expected to gain regulatory approval?
Pending positive Phase 3 trial outcomes, regulatory submissions are anticipated within the next 12-18 months, with approval timelines following standard review periods of approximately 6-12 months.

2. How does ULORIC differentiate itself from existing antipsychotics?
ULORIC’s unique mechanism targeting TAAR1 offers potential advantages in tolerability, particularly regarding metabolic side effects common with current dopamine-based therapies.

3. What are the main risks associated with ULORIC’s commercial success?
Risks include clinical trial setbacks, regulatory delays, unfavorable safety data, intense market competition, and payer reimbursement challenges.

4. What is the potential market size for ULORIC?
The global schizophrenia market exceeds $7 billion annually, with incremental growth expected. ULORIC’s addressable market could initially capture 10-15%, translating to hundreds of millions annually, with long-term potential reaching over $1 billion globally.

5. Could ULORIC target other psychiatric conditions?
Yes. Preliminary data suggest potential applications in bipolar disorder and depression, which could diversify revenue streams and enhance long-term growth prospects.

References

1. World Health Organization. "Schizophrenia Fact Sheet," WHO, 2022.
2. Sunovion Pharmaceuticals. "ULORIC Clinical Development Program," Sunovion, 2023.
3. MarketWatch. "Global Antipsychotic Drugs Market," 2022.
4. FDA. "Guidance for Industry: Clinical Trial Design for Antipsychotic Agents," FDA, 2021.
5. IQVIA. "Neuropsychiatric Drugs Market Analysis," IQVIA, 2022.