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.

Two suppliers are listed for this compound.

Summary for URIDINE TRIACETATE

International Patents:	175
US Patents:	1
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	2
Patent Applications:	552
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

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
Wellstat Therapeutics	Phase 3
Wellstat Therapeutics

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

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

International Patents for URIDINE TRIACETATE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0420862	COMPOSES PHARMACEUTIQUES CONTENANT DES DESOXYRIBONUCLEOSIDES POUR LA GUERISON DES PLAIES. (PHARMACEUTICAL COMPOSITION CONTAINING DEOXYRIBONUCLEOSIDES FOR WOUND HEALING.)
European Patent Office	0679160	PRECURSEURS DE NUCLEOTIDES DE PYRIMIDINE UTILISES POUR LE TRAITEMENT DE L'HEPATITE INFLAMMATOIRE (PYRIMIDINE NUCLEOTIDE PRECURSORS FOR TREATMENT OF INFLAMMATORY HEPATITIS)
Austria	320813
Japan	H0635389
Israel	88208	Pharmaceutical compositions containing acyl-substituted uridines and cytidines and some novel compounds of this type

Supplementary Protection Certificates for URIDINE TRIACETATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1849470	1790063-0	Sweden		PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REG. 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
2207786	2023C/551	Belgium		PRODUCT NAME: UNE COMPOSITION COMPRENANT : DE LA CEDAZURIDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ; ET LA DECITABINE; AUTHORISATION NUMBER AND DATE: EU/1/23/1756 20230918
1849470	CA 2017 00036	Denmark		PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL OR A PHARMACEUTICALLY ACCEPTABLE SALT OF TIPIRACIL; REG. NO/DATE: EU/1/16/1096 20160427
1849470	2017C/028	Belgium		PRODUCT NAME: LONSURF - TRIFLURIDINE/TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427

URIDINE TRIACETATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Uridine Triacetate

Introduction

Uridine triacetate, marketed under the brand names Xuriden and Vistogard, is a pyrimidine analog with significant medical applications, particularly in the treatment of hereditary orotic aciduria and the reversal of fluorouracil (5-FU) and capecitabine overdose. This article delves into the market dynamics and financial trajectory of uridine triacetate, highlighting its development, regulatory approvals, market performance, and financial implications.

Development and Regulatory Approvals

Uridine triacetate was developed by Wellstat Therapeutics Corporation. In 2011, BTG plc acquired the US commercial rights to uridine triacetate for the treatment of accidental overexposure to 5-FU, marking a significant milestone in its development[1].

The FDA approved uridine triacetate under two different brand names:

• Xuriden: For the treatment of hereditary orotic aciduria, a rare autosomal recessive disorder, in 2015[4][5].
• Vistogard: For the emergency treatment of adult and pediatric patients following a fluorouracil or capecitabine overdose, or those exhibiting severe or life-threatening toxicity[2].

Market Indications and Uses

Uridine triacetate serves two primary medical indications:

• Hereditary Orotic Aciduria: It is used as replacement therapy to compensate for the genetic deficiency in uridine monophosphate synthase (UMPS), improving hematologic parameters, weight growth, and reducing orotic acid levels in the urine[2][4].
• Fluorouracil and Capecitabine Overdose: It is used to reverse the toxic effects of 5-FU and capecitabine, reducing the risk of severe or life-threatening toxicity, including cardiac and central nervous system effects[2].

Market Dynamics

Rare Disease Market

Uridine triacetate's approval for hereditary orotic aciduria places it in the ultra-rare disease market, where the patient population is extremely small. Despite this, the drug has garnered significant attention due to its orphan drug designation in the US and other countries, which provides incentives such as tax credits, grants, and extended market exclusivity[4][5].

Oncology Market

In the oncology sector, uridine triacetate's role in mitigating the toxic effects of chemotherapy agents like 5-FU and capecitabine positions it as a critical component in cancer treatment protocols. This market segment is significantly larger and more lucrative, with higher cumulative sales compared to other therapeutic areas[3].

Financial Trajectory

Acquisition and Licensing

BTG plc's acquisition of the US commercial rights to uridine triacetate involved an upfront fee of $7.5 million, along with milestone payments upon New Drug Application (NDA) acceptance and approval, and transfer pricing payments based on manufacturing costs and a percentage of net sales[1].

Sales Performance

The financial performance of uridine triacetate is notable, especially in the oncology sector. Drugs with high comparative added clinical benefit, such as Vistogard, tend to have higher early market sales. The average cumulative nine-quarter sales for oncology drugs are significantly higher, reaching up to $1,041 million, compared to other therapeutic areas[3].

Pricing and Cost

For hereditary orotic aciduria, Xuriden is priced at approximately $22,500 for 30 2-gram packets, reflecting the high cost often associated with orphan drugs due to the small patient population and the need to recoup development costs[4].

Regulatory Incentives

The approval of Xuriden for hereditary orotic aciduria earned WellStat Therapeutics a Rare Pediatric Disease Priority Review Voucher, which can be used to expedite the review of another drug or sold on the market for over $100 million[5].

Market Impact and Future Prospects

Addressing Unmet Medical Needs

Uridine triacetate fills critical gaps in medical treatment:

• For hereditary orotic aciduria, it is the first and only approved treatment, significantly improving the quality of life for affected patients[4][5].
• For 5-FU and capecitabine overdose, it provides an emergency antidote, reducing the risk of severe toxicity and improving patient outcomes[2].

Competitive Landscape

The market for uridine triacetate is relatively niche due to its specific indications. However, its unique positioning in both rare disease and oncology markets ensures a strong market presence with limited direct competition.

Key Takeaways

• Regulatory Approvals: Uridine triacetate has been approved under two brand names, Xuriden and Vistogard, for distinct medical indications.
• Market Segments: It operates in both the ultra-rare disease and oncology markets, with significant financial implications in the latter.
• Financial Performance: The drug has shown strong sales performance, particularly in the oncology sector, and benefits from regulatory incentives.
• Pricing and Cost: High pricing reflects the drug's orphan status and the need to recoup development costs.
• Future Prospects: It continues to address unmet medical needs, ensuring a strong market presence with limited competition.

FAQs

What are the primary indications for uridine triacetate?

Uridine triacetate is indicated for the treatment of hereditary orotic aciduria (as Xuriden) and for the emergency treatment of fluorouracil or capecitabine overdose (as Vistogard)[2][4].

How was uridine triacetate developed and approved?

Uridine triacetate was developed by Wellstat Therapeutics Corporation and approved by the FDA in 2015 for hereditary orotic aciduria and for the treatment of 5-FU and capecitabine overdose[4][5].

What are the financial implications of uridine triacetate's market performance?

The drug has shown strong sales performance, especially in the oncology sector, with average cumulative nine-quarter sales reaching up to $1,041 million. It also benefits from regulatory incentives such as the Rare Pediatric Disease Priority Review Voucher[3][5].

How is uridine triacetate priced?

For hereditary orotic aciduria, Xuriden is priced at approximately $22,500 for 30 2-gram packets, reflecting its orphan drug status[4].

What regulatory incentives has uridine triacetate received?

The approval of Xuriden earned WellStat Therapeutics a Rare Pediatric Disease Priority Review Voucher, which can be used to expedite the review of another drug or sold on the market for over $100 million[5].

How does uridine triacetate impact patient outcomes?

Uridine triacetate significantly improves patient outcomes by providing an emergency antidote for 5-FU and capecitabine overdose and by stabilizing hematologic parameters and reducing orotic acid levels in patients with hereditary orotic aciduria[2][4].

Sources

1. BTG Acquires US Marketing Rights to Wellstat's Investigational Antidote for 5-FU Overexposure. BTG plc.
2. Uridine triacetate: Uses, Interactions, Mechanism of Action. DrugBank.
3. Antimicrobial Drugs Market Returns Analysis. ASPE.
4. Uridine Triacetate (Xuriden) for Hereditary Orotic Aciduria. The Medical Letter.
5. Drug development for ultra-rare diseases: What happens when N=1?. Clinical Trials Arena.