VISTIDE Drug Patent Profile

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

Vistide is a drug marketed by Gilead Sciences Inc and is included in one NDA.

The generic ingredient in VISTIDE is cidofovir. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cidofovir profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vistide

A generic version of VISTIDE was approved as cidofovir by MYLAN INSTITUTIONAL on June 27^th, 2012.

Summary for VISTIDE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	11
Patent Applications:	6,229
What excipients (inactive ingredients) are in VISTIDE?	VISTIDE excipients list
DailyMed Link:	VISTIDE at DailyMed

Recent Clinical Trials for VISTIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Centro de Investigación en. Enfermedades Infecciosas, Mexico	Phase 2
Gilead Sciences	Phase 1
M.D. Anderson Cancer Center	Phase 1

See all VISTIDE clinical trials

US Patents and Regulatory Information for VISTIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gilead Sciences Inc	VISTIDE	cidofovir	SOLUTION;INTRAVENOUS	020638-001	Jun 26, 1996		DISCN	Yes	No

Expired US Patents for VISTIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	VISTIDE	cidofovir	SOLUTION;INTRAVENOUS	020638-001	Jun 26, 1996	5,142,051

EU/EMA Drug Approvals for VISTIDE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Gilead Sciences International Limited	Vistide	cidofovir	EMEA/H/C/000121Vistide is indicated for the treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome (AIDS) and without renal dysfunction. Vistide should be used only when other agents are considered unsuitable.,	Withdrawn	no	no	no	1997-04-23

International Patents for VISTIDE

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

Country	Patent Number	Title	Estimated Expiration
South Korea	950004179
South Africa	8705283
New Zealand	221100	N-PHOSPHONYLMETHOXYALKYL PYRIMIDINES AND PURINES AND PHARMACEUTICAL COMPOSITIONS THEREOF
Japan	S6345289	N-PHOSPHONYLMETHOXYALKYL DERIVATIVE OF PURINE AND PYRIMIDINE BASE
Australia	7575987
Ireland	60117	N-phosphonylmethoxyalkyl derivatives of pyrimidine and purine bases, methods for their preparation and pharmaceutical compositions therefrom with antiviral activity
Luxembourg	90155

Supplementary Protection Certificates for VISTIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0253412	C970036	Netherlands		PRODUCT NAME: CIDOFOVIR,DESGEWENST IN DE VORM VAN EEN ZOUT MET AMMONIA,EEN ALKALIMETAAL OF EEN AMINE; REGISTRATION NO/DATE: EU/1/97/037/001 19970423
0253412	63/1997	Austria		PRODUCT NAME: CIDOFOVIR; REGISTRATION NO/DATE: K (97) 1176 19970423
0253412	97C0105	Belgium		PRODUCT NAME: CIDOFOVIR; REGISTRATION NO/DATE: EU/1/97/037/001 19970423
0253412	SPC/GB97/083	United Kingdom		PRODUCT NAME: CIDOFOVIR; REGISTERED: UK EU/1/97/037/001 19970423

Market Dynamics and Financial Trajectory for VISTIDE (Cidofovir)

Last updated: July 29, 2025

Introduction

VISTIDE, with the active ingredient cidofovir, is an antiviral agent primarily used to treat cytomegalovirus (CMV) retinitis in AIDS patients, especially when other treatments are ineffective or contraindicated. Approved by the FDA in 1996, VISTIDE has maintained a niche position in antiviral therapy, driven by evolving market dynamics, patent landscape, and emerging therapeutic alternatives. Understanding its market trajectory involves analyzing the drug's clinical profile, competitive landscape, regulatory environment, and broader healthcare trends.

Historical Market Position and Usage

VISTIDE's initial success was centered around the HIV epidemic, where CMV retinitis represented a significant opportunistic infection. Its intravenous administration and notable nephrotoxicity limited widespread popularity; nonetheless, it remained an essential option for treatment-resistant cases. Over time, advances in antiretroviral therapy (ART) dramatically reduced the incidence of CMV-related complications, impacting VISTIDE’s market but sustaining its role in specific patient subsets.

Current Market Dynamics

1. Evolving Clinical Guidelines

The paradigm shift brought by potent ART regimens reduced CMV retinitis cases, diminishing VISTIDE's overall demand. Current clinical guidelines recommend proactive control of HIV viremia, thus delaying or preventing CMV infections. Consequently, VISTIDE’s use is mostly confined to refractory cases or in regions with limited healthcare infrastructure where ART rollout remains incomplete.

2. Competitive Landscape and Alternative Therapies

The landscape has shifted with the emergence of newer antivirals such as valganciclovir—a more convenient oral formulation with superior safety profiles—and foscarnet, which is also injectable but exhibits different toxicity considerations. These drugs have largely supplanted VISTIDE in many settings, constraining market share and revenue prospects.

3. Regulatory and Patent Considerations

VISTIDE's patent exclusivity has long expired, opening the drug to generic manufacturers, which has intensified price competition. Regulatory agencies in different regions permit generic sales that often undercut branded prices, further limiting revenue. However, in certain markets with limited regulatory oversight, VISTIDE maintains some market presence.

4. Manufacturing and Supply Chain Factors

Manufacturing complexities, especially its complex synthesis and handling of nephrotoxic components, pose challenges for generic production. This limits the entry of new players and sustains some level of supply chain stability for remaining manufacturers.

5. Market Segments and Geographic Variability

Rich markets with comprehensive healthcare infrastructure have seen a significant decline in VISTIDE use; conversely, developing nations with limited access to newer antivirals rely more on existing formulations. Thus, global demand remains geographically sporadic but persistent in specific healthcare settings.

Financial Trajectory Analysis

1. Revenue Trends

Historical revenues for VISTIDE peaked during the late 1990s and early 2000s, corresponding with the height of CMV retinitis prevalence. Post-2010, revenues declined sharply, reflecting the reduced incidence due to better HIV management and competition from alternative drugs. According to industry reports, the drug's annual sales have plateaued at significantly lower levels, primarily sourced from legacy use and niche markets.

2. Pricing and Cost Considerations

The maturation of the market, along with patent expiries and generic competition, has driven prices downward. Low-margin environments have discouraged investments into production upgrades, affecting supply stability and potential innovation efforts.

3. R&D and Potential for Life Cycle Extension

There are limited R&D initiatives focused on VISTIDE derivatives or formulations aimed at reducing toxicity and improving delivery. Most pharmaceutical innovators have shifted focus toward novel antiviral agents targeting resistant strains and broader viral infections.

4. Investment Outlook and Market Forecast

Given the declining use and limited pipeline developments, the market outlook for VISTIDE remains subdued. Industry analyst forecasts suggest marginal growth or continued stagnation in revenue streams prioritizing alternative therapies. However, niche markets—such as pediatric or immunocompromised populations—and certain geographic regions maintain sustained, albeit small, demand.

5. Impact of Emerging Technologies

Advances in gene therapy and monoclonal antibodies targeting viral infections threaten to further cannibalize VISTIDE's market. Furthermore, developments in topical or less toxic systemic agents could replace injectable treatments, reducing the drug’s long-term financial relevance.

Regulatory Trajectory and Market Considerations

Regulatory agencies are increasingly emphasizing safety and efficacy, which may impact VISTIDE’s status owing to its nephrotoxicity. The path to obtaining new indications or formulations faces hurdles, constraining potential revenue avenues. However, orphan drug designations for specific indications could offer incentives for certain markets.

Conclusion

VISTIDE’s market dynamics are characterized by a substantial decline in global demand, driven by improved HIV management, alternative antivirals, and patent expiries. Its financial trajectory projects continued, modest revenue streams mostly confined to niche markets. To sustain viable commercial operations, stakeholders must explore life cycle extension strategies, such as new formulations or combination therapies, despite the competitive headwinds.

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Key Takeaways

• Market Demand Decline: The global reduction in CMV retinitis cases due to effective ART has significantly constrained VISTIDE's market.
• Competitive Pressures: Affordable, safer alternatives like valganciclovir dominate the landscape, limiting VISTIDE’s adoption.
• Generic Competition: Patent expiries and generic manufacturing have led to price erosion, suppressing revenues.
• Niche Market Potential: Developing regions with limited access to newer therapies continue to represent niche demand.
• Future Outlook: Limited pipeline developments and technological disruptions forecast a primarily declining financial trajectory with minimal growth prospects.

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FAQs

1. What are the primary clinical indications for VISTIDE?
VISTIDE is primarily indicated for the treatment of CMV retinitis in immunocompromised patients, notably those with AIDS.

2. Why has VISTIDE’s market share declined over recent years?
The decline stems from the widespread adoption of more convenient, safer, and effective antiviral agents, alongside improved HIV management reducing CMV incidence.

3. Are there any new developments or formulations of VISTIDE in pipeline?
Currently, there are limited or no significant pipeline developments aimed at reformulating VISTIDE to mitigate toxicity or improve delivery.

4. How does the generic market impact VISTIDE’s revenue?
Generic competition has led to lower prices and reduced revenue streams, especially in markets with regulatory approval for generics.

5. What regions offer the greatest potential for continued VISTIDE use?
Developing countries with limited healthcare infrastructure and access to newer antiviral agents represent niche markets where VISTIDE retains some relevance.

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Sources:
[1] U.S. Food and Drug Administration. (1996). VISTIDE (Cidofovir) Prescribing Information.
[2] Market Research Future. Antiviral Drugs Market Analysis. 2022.
[3] IQVIA. Global Pharmaceutical Market Data Reports. 2022.
[4] Pharmaceutical Industry Reports. (2023). Competitive Landscape of Antiviral Therapies.