URIDINE TRIACETATE - Generic Drug Details

What are the generic drug sources for uridine triacetate and what is the scope of freedom to operate?

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
D'Or Institute for Research and Education	PHASE1
Conselho Nacional de Desenvolvimento Cientfico e Tecnolgico	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	VISTOGARD	uridine triacetate	GRANULE;ORAL	208159-001	Dec 11, 2015		RX	Yes	Yes	7,776,838
Btg Intl	XURIDEN	uridine triacetate	GRANULE;ORAL	208169-001	Sep 4, 2015		RX	Yes	Yes

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	VISTOGARD	uridine triacetate	GRANULE;ORAL	208159-001	Dec 11, 2015	6,258,795
Btg Intl	XURIDEN	uridine triacetate	GRANULE;ORAL	208169-001	Sep 4, 2015	6,258,795

International Patents for URIDINE TRIACETATE

Country	Patent Number	Title	Estimated Expiration
Japan	2006096772	OXYPURINE NUCLEOSIDE FOR IMPROVING HEMOPOIESIS, HOMOLOGUE THEREOF AND ACYL DERIVATIVE THEREOF
Australia	663309
Germany	3856557
Mexico	171542	COMPOSICIONES FARMACEUTICAS QUE CONTIENEN DEOXIRRIBONUCLEOSIDOS PARA CICATRIZACION DE HERIDAS

Supplementary Protection Certificates for URIDINE TRIACETATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2207786	202340031	Slovenia		PRODUCT NAME: COMBINATION OF CEDAZURIDINE OR ITS PHARMACEUTICALLY ACCEPTEBLE SALT AND DECITABINE; NATIONAL AUTHORISATION NUMBER: EU/1/23/1756; DATE OF NATIONAL AUTHORISATION: 20230915; AUTHORITY FOR NATIONAL AUTHORISATION: EU
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
1849470	300889	Netherlands		PRODUCT NAME: TRIFLURIDINE IN COMBINATIE MET TIPIRACILHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160427
2207786	2023C/550	Belgium		PRODUCT NAME: CEDAZURIDINE, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/23/1756 20230918

Market dynamics and financial trajectory for uridine triacetate

Last updated: February 16, 2026

Uridine triacetate is an oral prodrug of uridine, used primarily as an antidote for certain chemotherapy agents and radiation treatments. It is also approved for the treatment of hereditary orotic aciduria, a rare genetic disorder. Its commercial prospects depend on regulatory status, competition, clinical development, and demand trends in its indication areas.

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What are the current market drivers for uridine triacetate?

1. FDA approval and indications:

   • Approved by the U.S. Food and Drug Administration (FDA) in 2015 for use as an antidote in patients treated with fluorouracil or capecitabine who experience overdose or toxicity.
   • Also approved for hereditary orotic aciduria in 2018.

2. Therapeutic niche and unmet needs:

   • Limited alternatives for overdose management of fluoropyrimidines.
   • Orphan drug designation for hereditary orotic aciduria enhances market exclusivity.

3. Regulatory environment:

   • Regulatory approval in the U.S., with potential for additional approvals in Europe and Japan.
   • No significant barriers to entry aside from its niche indication.

4. Clinical trial activity:

   • Ongoing research into broader applications, including management of side effects from chemotherapy and radiation therapy.

5. Pricing and reimbursement:

   • Limited pricing data; historically priced at premium levels due to niche use.
   • Reimbursement policies vary by country, influencing sales.

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How does the competitive landscape affect uridine triacetate?

• Limited direct competition:

  • No other drugs are approved specifically as antidotes for fluoropyrimidine overdose.
  • Alternative treatments include supportive care, which is less targeted.

• Indirect competition:

  • Advanced supportive care drugs for chemotherapy toxicity could influence market share.
  • Potential development of alternative antidotes or preventive strategies could dampen growth.

• Market exclusivity:

  • Patents securing market exclusivity extend through the late 2020s in the U.S.
  • Once expirations occur, generic versions could reduce prices and sales volumes.

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What are the key market barriers and challenges?

• Rare disease status:

  • Hereditary orotic aciduria is extremely rare, limiting revenue from this indication.

• Market awareness and clinician familiarity:

  • Adoption depends on clinician education and awareness in emergency and oncology settings.

• Regulatory hurdles in expanding indications:

  • New applications require comprehensive clinical trials, which are costly and time-consuming.

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How is the demand for uridine triacetate projected to evolve?

Factor	Impact	Notes
Oncology drug use	Increase	As fluoropyrimidine usage grows globally, overdose cases may increase.
Regulatory expansion	Potential	Approvals for additional indications could boost sales.
Market penetration	Variable	Effectiveness depends on clinician awareness and healthcare infrastructure.

• The overall demand is expected to grow slowly unless new indications emerge or usage of related chemotherapeutic agents increases significantly.

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What is the financial outlook for uridine triacetate?

1. Revenue estimates:

   • In 2021, estimated U.S. sales were approximately $50 million.
   • Growth projections suggest a compound annual growth rate (CAGR) of 3-5% over the next five years, driven by increased chemotherapy use and greater clinician awareness.

2. Profitability:

   • Profit margins are likely high due to limited competition and premium pricing.

3. R&D and commercialization costs:

   • Minimal for its current indications; primary expenses involve regulatory compliance, manufacturing, and marketing.

4. Market risks:

   • Market saturation risk post-patent expiry.
   • Regulatory delays for new indications.
   • Competitive pricing pressures if generics enter.

5. Long-term prospects:

   • Largely dependent on the drug's ability to expand beyond its current uses.
   • Partnerships with larger pharmaceutical firms could enhance market penetration.

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Key Takeaways

• Uridine triacetate's market hinges on its role as a niche antidote with limited competition.
• Growth prospects are modest but steady, influenced by chemotherapy trends and regulatory extensions.
• Revenue stability and profitability are high within current indications but face risks from patent expirations and potential competition.
• Clinical research into broader applications could alter its revenue trajectory.
• Market expansion outside the U.S. depends on regulatory approvals and clinician adoption.

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FAQs

1. When does the patent for uridine triacetate expire?
The primary patents are scheduled to expire in the late 2020s, with orphan drug exclusivity until 2025-2028 in the U.S.

2. Are there generic versions of uridine triacetate?
As of 2023, no generic versions are available; patent protections prevent competition.

3. What are the major risks for investment in uridine triacetate?
Patent expiration, regulatory delays in expanding indications, and emergence of better antidotes pose significant risks.

4. Can uridine triacetate be used in other medical conditions?
Potential exists if clinical trials demonstrate efficacy; however, currently, it is approved only for specific overdose and hereditary conditions.

5. How do reimbursement policies influence sales?
Reimbursement status varies by country; favorable policies in the U.S. support higher utilization, while restrictive policies elsewhere may limit growth.

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References

[1] FDA. "Uridine Triacetate (Vistogard) Approval." FDA, 2015.
[2] Orphan Drug Designation Tracking. U.S. FDA, 2018.
[3] Industry Sales Data, IQVIA, 2021.