xuriden Drug Patent Profile

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

Xuriden is a drug marketed by Btg Intl and is included in one NDA.

The generic ingredient in XURIDEN is uridine triacetate. There are thirty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the uridine triacetate profile page.

Summary for xuriden

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	73
Patent Applications:	350
Drug Prices:	Drug price information for xuriden
What excipients (inactive ingredients) are in xuriden?	xuriden excipients list
DailyMed Link:	xuriden at DailyMed

See drug prices for xuriden

US Patents and Regulatory Information for xuriden

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

Expired US Patents for xuriden

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

International Patents for xuriden

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

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2158269	ACYL DERIVATIVES OF GUANOSINE, INOSINE, XANTHOSINE, DEOXY-INOSINE, DEOXYGUANOSINE, INOSINE-2',3'-(ACYCLIC)-DIALCOHOL OR THEIR PHARMACEUTICALLY ACCEPTABLE SALTS, HEMOPOIESIS-STIMULATING PHARMACEUTICAL COMPOSITION, METHOD OF TREATMENT OF CYTOPENIA
Norway	317199
Israel	107900	Composition comprising an acyl derivative of a pyrimidine nucleotide precursor and an inhibitor of uridine phosphorylase or/and a purine nucleotide precursor for use in treatment and prevention of systemic inflammation inflammatory hepatitis and similar conditions and use of such components in the manufacture of medicaments
Australia	712835
Hong Kong	1005740

Supplementary Protection Certificates for xuriden

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2207786	2023C/550	Belgium		PRODUCT NAME: CEDAZURIDINE, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND 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	2017C/028	Belgium		PRODUCT NAME: LONSURF - TRIFLURIDINE/TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427
1849470	LUC00036	Luxembourg		PRODUCT NAME: TRIFLURIDINE COMBINEE AU TIPIRACIL OU UN SEL DE TIPIRACIL TEL QUE L'HYDROCHLORURE DE TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427
1849470	300889	Netherlands		PRODUCT NAME: TRIFLURIDINE IN COMBINATIE MET TIPIRACILHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160427

Xuriden Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for XURIDEN

Introduction to XURIDEN

XURIDEN, or uridine triacetate, is a groundbreaking treatment for hereditary orotic aciduria (HOA), a rare and potentially life-threatening genetic disorder. The drug was approved by the US Food and Drug Administration (FDA) on September 4, 2015, marking a significant milestone in the treatment of this orphan disease[4].

Market Approval and Launch

The FDA approval of XURIDEN was a crucial step in bringing this treatment to market. Following the approval, XURIDEN was made commercially available in early 2016. This launch was facilitated by Wellstat Therapeutics Corporation, the company behind the development of XURIDEN[1][4].

Rare Pediatric Disease Priority Review Voucher

Along with the FDA approval, Wellstat Therapeutics was granted a Rare Pediatric Disease Priority Review Voucher. This voucher is highly valuable as it can be used to expedite the review process for future drug applications, or it can be sold to other pharmaceutical companies. In this case, Wellstat had already entered into an agreement with AstraZeneca to transfer the voucher upon approval, highlighting the financial significance of such vouchers[4][5].

Market Drivers

The market for XURIDEN is driven by several key factors:

Innovation and New Launches

Constant innovation and new launches by key industry players, such as Merck & Co., Inc. and Wellstat Therapeutics Corporation, are driving the market growth. The approval of XURIDEN itself is a testament to this innovative spirit[1].

Rising Healthcare Awareness

Increasing healthcare awareness is expected to further aid the market growth in the forecast period. As more people become aware of the availability and benefits of treatments for rare diseases like HOA, the demand for XURIDEN is likely to increase[1].

Regulatory Support

The FDA's dedication to encouraging companies to develop treatments for rare pediatric diseases has been instrumental in the approval and market success of XURIDEN. Regulatory support through programs like the Best Pharmaceuticals for Children Act (BPCA) also plays a crucial role in fostering an environment conducive to the development of such treatments[3][4].

Financial Implications

Revenue Potential

Given the rarity and severity of HOA, XURIDEN has significant revenue potential. The drug addresses a previously unmet medical need, making it a critical treatment option for patients and their families. The commercial availability of XURIDEN in early 2016 marked the beginning of a new revenue stream for Wellstat Therapeutics[1][4].

Priority Review Voucher

The Rare Pediatric Disease Priority Review Voucher granted to Wellstat Therapeutics holds substantial financial value. These vouchers can be sold for tens of millions of dollars, providing a significant financial boost to the company. In the case of XURIDEN, the voucher was transferred to AstraZeneca as part of a pre-existing agreement, highlighting the lucrative nature of these vouchers[4][5].

Partnerships and Agreements

The agreement between Wellstat Therapeutics and AstraZeneca for the transfer of the Priority Review Voucher demonstrates the financial strategies involved in the development and marketing of rare disease treatments. Such partnerships can provide necessary funding and resources to support the commercialization of drugs like XURIDEN[4].

Clinical Impact and Market Acceptance

Clinical Efficacy

XURIDEN has shown promising clinical results in treating HOA. The drug delivers uridine into the circulation, compensating for the genetic deficiency in uridine synthesis in patients with HOA. This leads to a reduction in the overproduction of orotic acid and stabilization of hematologic parameters, which are critical for managing the disease[2].

Patient Outcomes

Clinical trials have demonstrated that XURIDEN can stabilize or improve hematologic parameters in patients with HOA. For instance, patients switched from oral uridine to XURIDEN showed stability in their hematologic parameters over a 24-month period, highlighting the drug's effectiveness and acceptance in the medical community[2].

Market Growth Projections

Increasing Demand

The rising awareness of rare diseases and the availability of treatments like XURIDEN are expected to drive market growth. As more healthcare providers and patients become aware of the benefits of XURIDEN, the demand for this treatment is likely to increase, contributing to market expansion[1].

Competitive Landscape

The market for HOA treatments is relatively niche due to the rarity of the disease. However, the approval of XURIDEN has set a precedent for future treatments, potentially attracting more companies to this space. The competitive landscape, while currently limited, may evolve as more treatments are developed and approved[1].

Challenges and Opportunities

Funding for Rare Disease Research

Despite the progress made with XURIDEN, funding for rare disease research remains a challenge. Programs like the BPCA are underfunded, which can limit the scope and scale of research and development for treatments like XURIDEN. Addressing these funding gaps is crucial for sustaining innovation in this area[3].

Regulatory Incentives

Regulatory incentives, such as the Rare Pediatric Disease Priority Review Voucher, are essential for encouraging companies to invest in rare disease treatments. These incentives can help offset the high costs associated with drug development and provide a financial return on investment[4].

Key Takeaways

• FDA Approval: XURIDEN was approved by the FDA in September 2015 for the treatment of hereditary orotic aciduria.
• Commercial Availability: The drug was made commercially available in early 2016.
• Priority Review Voucher: Wellstat Therapeutics was granted a Rare Pediatric Disease Priority Review Voucher, which was transferred to AstraZeneca.
• Clinical Efficacy: XURIDEN has shown promising clinical results in stabilizing or improving hematologic parameters in patients with HOA.
• Market Growth: The market is driven by increasing healthcare awareness and regulatory support.
• Financial Implications: The drug has significant revenue potential, and the Priority Review Voucher holds substantial financial value.

FAQs

Q: What is XURIDEN used for? A: XURIDEN (uridine triacetate) is used for the treatment of hereditary orotic aciduria (HOA), a rare genetic disorder.

Q: When was XURIDEN approved by the FDA? A: XURIDEN was approved by the FDA on September 4, 2015.

Q: What is the significance of the Rare Pediatric Disease Priority Review Voucher? A: The voucher is highly valuable as it can expedite the review process for future drug applications or be sold to other pharmaceutical companies.

Q: How does XURIDEN work? A: XURIDEN delivers uridine into the circulation, compensating for the genetic deficiency in uridine synthesis in patients with HOA.

Q: What are the clinical outcomes of XURIDEN treatment? A: Clinical trials have shown that XURIDEN can stabilize or improve hematologic parameters in patients with HOA.

Cited Sources

1. Global Hereditary Orotic Aciduria Treatment Market - Expert Market Research
2. XURIDEN® (uridine triacetate) oral granules - FDA
3. Documents for the Record – 2/29/2024 - House.gov
4. Wellstat Therapeutics Corporation Announces FDA Approval Of XURIDEN - BioSpace
5. AstraZeneca Scores 'Voucher' On Wellstat's Xuriden Approval - Scrip