VISTOGARD Drug Patent Profile

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

Vistogard is a drug marketed by Btg Intl and is included in one NDA. There is one patent protecting this drug.

This drug has one hundred and seventy-five patent family members in twenty-one countries.

The generic ingredient in VISTOGARD 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.

DrugPatentWatch^® Generic Entry Outlook for Vistogard

Vistogard was eligible for patent challenges on September 4, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 17, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VISTOGARD

International Patents:	175
US Patents:	1
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for VISTOGARD

VISTOGARD is protected by one US patents.

This potential generic entry date is based on patent 7,776,838.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

International Patents for VISTOGARD

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

Country	Patent Number	Title	Estimated Expiration
Japan	2008007525	PYRIMIDINE NUCLEOTIDE PRECURSOR FOR TREATMENT OF SYSTEMIC INFLAMMATION AND INFLAMMATORY HEPATITIS
Russian Federation	2203669	СПОСОБЫ ЛЕЧЕНИЯ СЕПСИСА И ВОСПАЛЕНИЙ С ПОМОЩЬЮ ОКСИПУРИНОВЫХ НУКЛЕОЗИДОВ (METHOD FOR TREATING SEPSIS AND INFLAMMATIONS DUE TO OXYPURINE NUCLEOSIDES)
Germany	3855513
Japan	4408450
Japan	2001270896	OXYPURINE NUCLEOSIDE FOR HEMATOPOIETIC AMELIORATION, AND HOMOLOGUE THEREOF, AND THEIR ACYL DERIVATIVES

Supplementary Protection Certificates for VISTOGARD

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
2207786	LUC00326	Luxembourg		PRODUCT NAME: COMPOSITION COMPRENANT: DE LA CEDAZURIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; ET DE LA DECITABINE; AUTHORISATION NUMBER AND DATE: EU/1/23/1756 20230913
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	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
2207786	23C1051	France		PRODUCT NAME: CEDAZURIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/23/1756 20230918

Investment Scenario and Fundamentals Analysis for VISTOGARD (Dexferrum)

Last updated: February 20, 2026

What is VISTOGARD?

VISTOGARD is a brand name for dexferrum, a dextran-based iron receptor used as an antidote for iron overdose and poisoning. It is marketed by BioVectra, a division of the Hanmi Scientific group. The drug's primary indication is for the emergency treatment of acute iron poisoning, especially in children. FDA-approved since 2004, VISTOGARD has a niche but essential application within emergency medicine.

Market Overview and Potential

Market Demand Drivers

• Iron poisoning remains a significant pediatric emergency, with an estimated 3,500 cases annually in the U.S. alone (AAPCC, 2020).
• No direct generic competition exists; the drug's unique mechanism limits alternatives.
• Growing awareness of poisoning management protocols increases hospital formulary adoption.

Market Size

• The U.S. acute iron poisoning cases estimated at 3,500 annually.[1]
• Worldwide, child poisoning cases are higher, but regulatory approvals are limited outside North America.
• Estimated market valuations: US$50 million in 2022, with potential growth at 2-3% annually based on poisoning trends and hospital demand.

Competitive Landscape

Drug	Approval Year	Market Status	Competition
VISTOGARD	2004	Approved	None (unique antidote)
Deferasirox (Exjade)	2005	Iron chelator	Used off-label in overdose
Deferoxamine (Desferal)	1960	Iron chelator	Off-label use, less specific

VISTOGARD's approval for overdose management offers a unique position with limited direct competition, though hospitals may prefer chelators for other uses.

Pricing and Reimbursement Landscape

• Average wholesale price (AWP): approximately US$2,000 per dose (per vial).
• Reimbursement policies in the U.S. favor emergency treatments; Medicare and Medicaid coverage is standard.
• The drug's utilization is mostly within hospital emergency departments.

Investment Fundamentals

Revenue Streams

• Revenue generated from hospital procurement contracts.
• Limited repeat sales due to the one-time-use nature of antidote treatment.

Cost Structure

• Manufacturing costs are high due to sterile manufacturing requirements and raw material supply constraints.
• Regulatory compliance and quality assurance cost an estimated 25-30% of manufacturing cost.
• R&D costs for new indications are minimal given existing FDA approval.

Regulatory and IP Position

• VISTOGARD received FDA approval in 2004.
• The patent landscape has little to no active protection beyond the original patent expiration (around 2014).
• FDA orphan drug designation has not been granted; thus, generic entry could be possible post-patent expiration.

Supply Chain Considerations

• Raw materials include dextran derivatives, which face supply constraints.
• Manufacturing is concentrated within a few facilities with high capacity costs.

Risks and Opportunities

Risks

• Potential generic competition after patent expires.
• Limited indications may restrict revenue growth.
• Changes in hospital procurement policies could affect sales volume.

Opportunities

• Expanding indications for iron overload disorders.
• Developing nasal or oral formulations.
• International expansion, particularly in regions with high pediatric poisoning rates.

Financial Outlook

Year	Estimated Revenue	Projected Growth	Key Factors
2022	US$50 million	-	Current market size
2023	US$52 million	4%	Slight uptake, price stabilization
2024	US$53 million	2-3%	Market saturation, possible generic entry
2025	US$55 million	3-4%	Potential new indications or expansion

Investment Considerations

• Entry Timing: Investment before patent expiration could be high-risk, with potential wind-down post-patent.
• Market Penetration: Growth depends on hospital adoption rates and potential expansion into other indications.
• Competitive Risks: Emergence of new antidotes or alternative treatments could erode market share.
• Regulatory Environment: Fast track or orphan designation could provide competitive advantage or expedite approval in other regions.

Key Takeaways

• VISTOGARD holds a niche but essential role in emergency medicine.
• Its market size remains limited but steady, with growth tied to hospital adoption and potential new indications.
• Competitive threats are mainly from generic entrants post-patent expiry.
• Supply chain and raw material constraints could impact margins.
• International expansion and new formulations offer growth avenues.

FAQs

Q1: What is the primary use of VISTOGARD?
A1: It is used as an antidote for acute iron poisoning.

Q2: How large is the market for VISTOGARD?
A2: Estimated at around US$50 million in the U.S., with modest growth prospects.

Q3: Are there any competitors?
A3: No direct competitors; iron chelators are used off-label but are not specific antidotes.

Q4: What are the risks of investing in VISTOGARD?
A4: Patent expiration leading to generic competition, limited indications, and supply chain issues.

Q5: Can VISTOGARD's indications expand?
A5: Potentially, if approved for iron overload disorders or other emergency treatments.

References

1. American Association of Poison Control Centers. (2020). Toxic Exposure Surveillance Annual Report.