VISTOGARD Drug Patent Profile

When do Vistogard patents expire, 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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Patent Applications:	350
Drug Prices:	Drug price information for VISTOGARD
What excipients (inactive ingredients) are in VISTOGARD?	VISTOGARD excipients list
DailyMed Link:	VISTOGARD at DailyMed

See drug prices for VISTOGARD

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

NDA:

208159

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.

Pharmacology for VISTOGARD

Ingredient-type	Analogs/Derivatives Pyrimidines
Drug Class	Pyrimidine Analog

US Patents and Regulatory Information for VISTOGARD

VISTOGARD is protected by one US patents.

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

Expired US Patents for VISTOGARD

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

International Patents for VISTOGARD

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0712629	Dérivés acylés de déoxyribonucléoside et leurs utilisations (Acyl deoxyribonucleoside derivatives and uses thereof)
European Patent Office	1157698
Finland	893100
Germany	68910973
Hong Kong	1003425
Russian Federation	2115410	COMPOSITION, METHOD OF HEALING STIMULATION
World Intellectual Property Organization (WIPO)	9640165

Supplementary Protection Certificates for VISTOGARD

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2207786	301256	Netherlands		PRODUCT NAME: CEDAZURIDINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1756 20230918
2207786	301257	Netherlands		PRODUCT NAME: SAMENSTELLING WELKE OMVAT: CEDAZURIDINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; EN DECITABINE; REGISTRATION NO/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
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	LUC00327	Luxembourg		PRODUCT NAME: CEDAZURIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/23/1756 20230918
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

Market Dynamics and Financial Trajectory for Vistogard

Introduction

Vistogard, also known as uridine triacetate, is an orally administered antidote for 5-fluorouracil (5-FU) toxicity, a common and potentially fatal side effect of chemotherapy. Developed by Wellstat, the drug's market performance and financial trajectory are influenced by several key factors, including its clinical efficacy, market competition, and the strategic decisions of its marketing partners.

Clinical Efficacy and Indication

Vistogard was the first commercially available drug to address 5-FU toxicity, making it a critical treatment option for patients undergoing chemotherapy with 5-FU or capecitabine. The efficacy of Vistogard was assessed in two open-label trials involving 135 patients, with the primary outcome being survival at 30 days or until the resolution of 5-FU toxicity symptoms[5].

Market Entry and Distribution Agreement

Wellstat, lacking a sales team, entered into a distribution agreement with BTG (now part of Boston Scientific) in 2011. BTG gained the exclusive rights to promote, distribute, and sell Vistogard in the U.S. for a distribution rights fee of $7.5 million and agreed to pay milestone payments and royalties on sales[4].

Initial Market Projections and Expectations

At the time of the agreement, BTG executives projected that Vistogard could generate up to $60 million in peak annual sales. However, these projections were based on an initial strategic focus on specialty pharmaceuticals, which later shifted towards interventional medicine[4].

Strategic Shift and Impact on Sales

Following the distribution agreement, BTG's corporate strategy shifted significantly. By 2013, BTG adopted a new strategic plan, the "BTG – 2020/2021 Vision," which prioritized interventional medicine over specialty pharmaceuticals. This shift led to reduced investment in the Pharmaceuticals Division, which included Vistogard. Despite recommendations from consultants like ZS Associates to expand the sales team to achieve forecasted sales, BTG's leadership chose to cut costs instead[4].

Sales Performance

The sales performance of Vistogard has been below initial projections. The drug's quarterly sales have been relatively low compared to other drugs in similar cohorts. For instance, Vistogard's sales remained very low for several years after its launch, unlike some other drugs that saw significant growth after the first year[1].

Quarterly Sales Data

Vistogard's sales data show that it did not achieve the expected growth. In contrast to drugs like Avycaz, which reached up to $99.54 million in quarterly sales, Vistogard's sales were significantly lower. The drug's sales trajectory did not align with the higher sales seen in the oncology cohort or even some non-AM comparator drugs[1].

Comparative Added Clinical Benefit Score

The analysis of the first 9 quarters of sales versus the overall comparative added clinical benefit score indicates that while drugs with higher clinical benefit scores tend to have higher sales, Vistogard's performance was an exception. Despite its critical clinical benefit, Vistogard's early market sales were uncharacteristically low[2].

Financial Implications

The financial implications of Vistogard's underperformance are significant. The reduced sales and lack of investment in the sales team meant that BTG did not realize the projected returns. The cost-neutral approach to launching Vistogard, as directed by BTG's leadership, limited the drug's market penetration and revenue generation[4].

Market Competition

Vistogard operates in a niche market addressing 5-FU toxicity, but its sales have been impacted by the broader strategic decisions of its marketing partner. The lack of aggressive marketing and sales efforts has allowed other drugs to dominate their respective markets, while Vistogard's potential remains underutilized[4].

Lessons Learned

The case of Vistogard highlights several key lessons for pharmaceutical companies:

• Strategic Alignment: The success of a drug is heavily dependent on the strategic alignment of the marketing partner. A shift in corporate strategy can significantly impact the drug's market performance.
• Investment in Sales: Adequate investment in the sales team and marketing efforts is crucial for achieving projected sales figures.
• Clinical Benefit and Market Demand: While clinical efficacy is essential, it is not the sole determinant of market success. Market demand and competitive landscape also play critical roles.

Key Takeaways

• Vistogard's market performance has been below initial projections due to strategic shifts and reduced investment by BTG.
• The drug's clinical efficacy is high, but its sales have been impacted by lackluster marketing and sales efforts.
• Strategic alignment and adequate investment in sales are critical for the success of pharmaceutical products.

FAQs

What is Vistogard used for?

Vistogard is an orally administered antidote for 5-fluorouracil (5-FU) toxicity, a common and potentially fatal side effect of chemotherapy.

Who developed Vistogard?

Vistogard was developed by Wellstat.

What was the initial market projection for Vistogard's sales?

BTG executives initially projected that Vistogard could generate up to $60 million in peak annual sales.

Why did Vistogard's sales not meet initial projections?

Vistogard's sales were impacted by BTG's strategic shift away from specialty pharmaceuticals and towards interventional medicine, leading to reduced investment in the sales team and marketing efforts.

How does Vistogard's sales performance compare to other drugs in its cohort?

Vistogard's sales have been significantly lower compared to other drugs in similar cohorts, particularly those in the oncology cohort.

Sources

1. NCBI: MARKET PERFORMANCE ANALYSIS - Antimicrobial Drugs ...
2. ASPE: antimicrobial drugs market returns analysis final
3. Clarivate: Life sciences licensing deals in the fourth quarter of 2017
4. Delaware Courts: in the court of chancery of the state of delaware
5. Vistogard.com: Efficacy Data Summary | Vistogard®(uridine triacetate) oral granules