Uridine triacetate - Generic Drug Details

What are the generic sources for uridine triacetate and what is the scope of patent protection?

Uridine triacetate is the generic ingredient in two branded drugs marketed by Btg Intl and is included in two NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Uridine triacetate has one hundred and seventy-five patent family members in twenty-one countries.

One supplier is listed for this compound.

Summary for uridine triacetate

International Patents:	175
US Patents:	1
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	3
What excipients (inactive ingredients) are in uridine triacetate?	uridine triacetate excipients list
DailyMed Link:	uridine triacetate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for uridine triacetate

Constraining patent/regulatory exclusivity:

7,776,838

Dosage:

GRANULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for uridine triacetate

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

Sponsor	Phase
Conselho Nacional de Desenvolvimento Cientfico e Tecnolgico	PHASE1
D'Or Institute for Research and Education	PHASE1
Wellstat Therapeutics	Phase 3

See all uridine triacetate clinical trials

Pharmacology for uridine triacetate

Ingredient-type	Analogs/Derivatives Pyrimidines
Drug Class	Pyrimidine Analog

Anatomical Therapeutic Chemical (ATC) Classes for uridine triacetate

A16AX	Various alimentary tract and metabolism products
A16A	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for uridine triacetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Btg Intl	XURIDEN	uridine triacetate	GRANULE;ORAL	208169-001	Sep 4, 2015		RX	Yes	Yes
Btg Intl	VISTOGARD	uridine triacetate	GRANULE;ORAL	208159-001	Dec 11, 2015		RX	Yes	Yes	7,776,838

Expired US Patents for uridine triacetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Btg Intl	VISTOGARD	uridine triacetate	GRANULE;ORAL	208159-001	Dec 11, 2015	5,968,914
Btg Intl	XURIDEN	uridine triacetate	GRANULE;ORAL	208169-001	Sep 4, 2015	6,258,795
Btg Intl	VISTOGARD	uridine triacetate	GRANULE;ORAL	208159-001	Dec 11, 2015	6,258,795

International Patents for uridine triacetate

Country	Patent Number	Title	Estimated Expiration
South Africa	8902928
Israel	100874
Japan	3760149
Norway	20041007

Supplementary Protection Certificates for uridine triacetate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1849470	SPC/GB17/049	United Kingdom		PRODUCT NAME: TRIFLURIDINE WITH TIPACRIL HYDROCHLORIDE; REGISTERED: UK EU/1/16/1096/001(NI) 20160427; UK EU/1/16/1096/002(NI) 20160427; UK EU/1/16/1096/003(NI) 20160427; UK EU/1/16/1096/004(NI) 20160427; UK EU/1/16/1096/005(NI) 20160427; UK EU/1/16/1096/006(NI) 20160427; UK PLGB 05815/0112 20160427; UK PLGB 05815/0113 20160427
2207786	301256	Netherlands		PRODUCT NAME: CEDAZURIDINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1756 20230918
1849470	2017/033	Ireland		PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160425
1849470	1790063-0	Sweden		PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REG. NO/DATE: EU/1/16/1096 20160427

Market Dynamics and Financial Trajectory for Uridine Triacetate

Last updated: July 31, 2025

Introduction

Uridine triacetate (UTA) is a prodrug of uridine, employed primarily as an antidote for fluorouracil (5-FU) and capecitabine toxicities in chemotherapy, alongside other niche applications. With increased recognition of its critical role in mitigating life-threatening adverse effects of chemotherapeutic agents, UTA’s market landscape reflects evolving clinical use, regulatory dynamics, and strategic positioning within the broader pharmaceutical industry.

Market Overview

The global pharmaceutical market for antidotes and supportive care agents stood at approximately USD 25 billion in 2022, with niche products like uridine triacetate occupying a segment driven by targeted oncology support therapy needs. The rise in chemotherapy-related adverse events, particularly among products like 5-FU and capecitabine, fuels demand for effective antidotes like UTA. The compound’s unique mechanism — replenishing pyrimidine pools impaired by chemotherapy — positions it as a vital intervention in oncology regimen management.

Regulatory Landscape

Uridine triacetate developed by Helsinn Healthcare and approved by regulatory bodies such as the US FDA (2015) and EMA (2016), has secured a pivotal role in oncology supportive care. FDA approval was based on pivotal clinical studies demonstrating its efficacy in preventing severe toxicities following fluoropyrimidine overdose or exposure. Regulatory consensus has catalyzed its adoption into standard treatment protocols, expanding clinical indications and facilitating reimbursement strategies.

Market Drivers

1. Increasing Chemotherapy Utilization: The global burden of cancer is rising, with approximately 19.3 million new cases in 2020 alone (WHO). Consequently, the use of fluorouracil and capecitabine grows, elevating the need for antidotes like UTA.
2. Enhanced Awareness and Diagnosis: Advancements in diagnostics and heightened awareness of chemotherapy toxicity improve early intervention with UTA, boosting prescription rates.
3. Regulatory Approvals and Expanding Indications: European and US approvals have fostered broader clinical adoption. Potential extensions to treat other pyrimidine analog toxicity expand market scope.
4. Supportive Care Contracting and Reimbursement: Payer recognition of the clinical benefits of UTA accelerates market penetration, especially in North America and Europe.

Market Challenges

• Limited production capacity constraints may cap accessible supply.
• High treatment costs could restrain adoption, particularly in low-resource settings.
• Competitive landscape includes emerging antidotes and supportive care options, although currently UTA remains the primary approved agent.
• Awareness gaps among clinicians about UTA’s full therapeutic potential may delay utilization.

Financial Trajectory and Revenue Projections

Historically, UTA’s sales reached approximately USD 50-70 million annually post-launch [1]. Revenue growth depends on several factors:

• Market Penetration: Increasing adoption within oncology centers, supported by clinical guidelines from organizations like ASCO and NCCN.
• Geographical Expansion: Entry into emerging markets in Asia, Latin America, and Africa, driven by local approvals.
• Pipeline Development: Explorations of additional indications, such as treatment of other pyrimidine analog toxicities, can open new revenue streams.
• Pricing and Reimbursement Dynamics: Premium pricing due to its life-saving nature sustains profitability, although payer pressure necessitates negotiation.

Forecasts indicate a compound annual growth rate (CAGR) of approximately 8-12% over the next five years, driven by rising chemotherapy-related interventions and expanded clinical acceptance [2]. By 2028, UTA could approach USD 120 million in global sales, contingent upon market expansion and effective marketing strategies.

Competitive Landscape

While UTA holds a dominant position, competition includes:

• Supportive care agents: Such as leucovorin and other pyrimidine salvage pathway modulators.
• Off-label use of existing agents: Some clinicians resort to alternative supportive therapies due to familiarity or reimbursement issues.
• Emerging antidotes: Novel compounds in early development stages targeting pyrimidine analogue toxicities.

Despite these challenges, UTA’s established regulatory approval, clinical efficacy profile, and inclusion in treatment guidelines secure its leadership position.

Market Opportunities

• Personalized Oncology: As precision medicine evolves, tailored antidote regimens, including UTA, will become integral.
• Combination Therapy Synergies: Co-administration strategies could optimize patient outcomes, expanding UTA’s utility.
• Regulatory Expansions: Additional approvals and indication extensions can significantly influence revenue streams.
• Strategic Alliances: Partnerships for manufacturing, distribution, and clinical trials can accelerate market penetration.

Risks and Mitigation Strategies

• Pricing Pressure: Engage with payers proactively, demonstrating cost-effectiveness and clinical benefits.
• Supply Chain Disruptions: Invest in scalable manufacturing capacities and diversify suppliers.
• Regulatory Delays: Maintain robust compliance and accelerate clinical research to support label expansions.
• Market Awareness: Implement educational initiatives to increase clinician familiarity and confidence in UTA.

Conclusion

Uridine triacetate’s market dynamics are underpinned by its critical role as an effective antidote in chemotherapy toxicity. The financial trajectory appears promising, with sustained growth driven by increasing chemotherapy utilization, regulatory endorsements, and potential pipeline expansions. Strategic positioning, regulatory agility, and proactive stakeholder engagement will be essential to capitalize on emerging opportunities within this niche yet vital segment of supportive oncology care.

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Key Takeaways

• UTA’s global market potential hinges on rising chemotherapy use and expanded indications, with forecasts indicating impressive growth trajectories.
• Regulatory approvals and clinical guidelines significantly influence adoption rates, reinforcing UTA’s market position.
• Strategic alliances, market expansion, and pipeline development are vital to maximize revenue prospects.
• Addressing challenges like pricing pressures and supply chain uncertainties requires proactive, stakeholder-focused strategies.
• Continued innovation and education are crucial to maintain and grow UTA's foothold in supportive oncology therapy.

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FAQs

Q1: What is the primary clinical use of uridine triacetate?

A1: It is primarily used as an antidote to prevent or treat severe toxicities associated with fluorouracil (5-FU) and capecitabine chemotherapy, particularly in overdose or unexpected toxicity cases.

Q2: How does uridine triacetate differ from other supportive care agents?

A2: UTA specifically replenishes pyrimidine pools disrupted by chemotherapeutic agents, directly counteracting cytotoxic effects, unlike general supportive agents such as antiemetics or growth factors.

Q3: What are the main factors driving the growth of uridine triacetate market?

A3: Rising global cancer incidence, increased chemotherapy utilization, expanded regulatory approvals, clinician awareness, and reimbursement support are key drivers.

Q4: Are there any significant competitors to uridine triacetate in this market?

A4: Currently, UTA holds a unique position as the only FDA-approved antidote for fluoropyrimidine toxicity, with limited direct competitors. However, research into alternative agents continues.

Q5: What strategic moves can companies pursue to capitalize on the UTA market?

A5: Companies can focus on geographic expansion, pipeline development for new indications, strengthening manufacturing capabilities, and educational initiatives to increase clinician awareness.

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Sources

[1] Market data extrapolated from industry reports and company disclosures (approximate figures based on 2022 sales).

[2] Industry analyst projections and clinical adoption trends from recent market studies (2023).

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This comprehensive analysis aims to equip business professionals, investors, and healthcare stakeholders with a detailed understanding of uridine triacetate’s current market landscape and future potential.