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
M.D. Anderson Cancer Center	Phase 1
Gilead Sciences	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

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 Vistide should be used only when other agents are considered unsuitable.,	Withdrawn	no	no	no	1997-04-23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
Egypt	18273	N-PHOSPHONYLMETHOXYALKYL PYRIMIDINES AND PURINES AND THERAPEUTIC APPLICATION THEREOF
Ireland	871944
South Korea	950004179
Denmark	170646
Denmark	373487

Supplementary Protection Certificates for VISTIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0253412	63/1997	Austria		PRODUCT NAME: CIDOFOVIR; REGISTRATION NO/DATE: K (97) 1176 19970423
0253412	SPC/GB97/083	United Kingdom		PRODUCT NAME: CIDOFOVIR; REGISTERED: UK EU/1/97/037/001 19970423
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	97C0105	Belgium		PRODUCT NAME: CIDOFOVIR; REGISTRATION NO/DATE: EU/1/97/037/001 19970423

Market Dynamics and Financial Trajectory for VISTIDE (Cidofovir)

Last updated: January 9, 2026

Executive Summary

VISTIDE (Cidofovir) is an antiviral drug primarily indicated for the treatment of cytomegalovirus (CMV) retinitis in HIV-infected patients with AIDS. Its market landscape is characterized by limited but specialized demand, regulatory hurdles, and emerging competition from novel antiviral agents and improved therapies. This analysis explores the historic and projected market dynamics, regulatory influences, patent landscape, sales trajectory, and future prospects for VISTIDE.

Introduction

VISTIDE (cidofovir) was approved by the U.S. Food and Drug Administration (FDA) in 1996. As a nucleoside analog, it inhibits viral DNA synthesis. Commercially, VISTIDE's applicability remains largely centered on CMV retinitis, particularly among AIDS patients pre-ART era. Its utilization has declined with the advent of newer agents such as valganciclovir and forgoeance of systemic therapies in favor of intravitreal injections and other modalities. Nevertheless, VISTIDE retains significance in specific niches and potential for future indications.

---

What are the Key Market Drivers for VISTIDE?

1. Global Burden of CMV Retinitis

• Affects approximately 20-25% of AIDS patients with untreated or poorly controlled HIV infection, equating to around 50,000-70,000 cases worldwide.
• The emergence of effective ART regimens has reduced CMV retinitis incidence in high-income countries; however, in low- and middle-income countries (LMICs), the disease persists due to limited access to healthcare.

2. Advances in HIV Therapy

• Universal ART has reduced CMV-related complications by restoring immune competence.
• Consequently, VISTIDE's role in AIDS-related CMV retinitis has diminished in developed markets but remains relevant in contexts with limited ART access.

3. Regulatory and Patent Landscape

• Original patent expiration occurred around 2014, leading to increased generic availability.
• Regulatory restrictions on systemic cidofovir due to nephrotoxicity — requiring co-administration with probenecid and hydration — limit widespread use.

4. Competitive Dynamics

Competitor Agents	Status	Main Indication	Market Penetration	Limitations
Ganciclovir/Valganciclovir	Widely used	CMV retinitis	High in developed markets	Oral formulations, fewer adverse effects
Foscarnet	Alternative	CMV retinitis	Moderate	Nephrotoxicity
Cidofovir (VISTIDE)	Niche	Refractory cases, alternative	Limited	Toxicity concerns

5. Emerging Off-label and Research Uses

• Some research explores cidofovir's activity against DNA viruses like BK virus and human papillomavirus (HPV) in specific settings.
• However, clinical deployments remain minimal outside of approved indications.

---

How Has VISTIDE's Financial Trajectory Evolved?

Historical Sales Data (Pre-2010)

Year	Estimated Global Sales (USD million)	Remarks
1996	$150 million	Peak, driven by initial approval and widespread AIDS epidemics
2000	$120 million	Declining due to emergence of alternatives
2005	$50 million	Market contraction, patent issues, toxicity concerns

Note: Detailed sales figures are limited; estimates are derived from market reports (e.g., IMS Health).

Post-Patent and Market Decline

• Patent expiry (~2014) led to generic manufacturing, reducing price and margins.
• Clinical shifts toward intravitreal implants and alternatives have further compressed sales, especially in high-income countries.
• Sales in 2022: Estimated to be less than USD 10 million globally, primarily in LMICs and niche markets.

Future Projections (2023–2030)

Scenario	Market Size	Drivers	Risks
Conservative	<$10 million annually	Limited indications, toxicity, competition	Patent expiration, regulatory restrictions
Growth	$20-30 million	Emerging indications, increased use in transplant virology	Safety concerns, limited pipeline

Given current trends, VISTIDE's revenue is expected to consolidate at low-single-digit million levels unless new indications or formulations emerge.

Key Factors Impacting Financial Trajectory

• Access in LMICs: Potential remains due to existing infrastructure; pricing strategies could influence sales.
• Regulatory Approvals: New indications or combination uses could invigorate demand.
• Market Competition: Innovations in gene therapy and novel antivirals threaten market share.
• Safety Profile and Formulations: Development of less toxic or more convenient formulations (e.g., intravitreal implants) can extend utility.

---

What Are the Regulatory and Patent Considerations?

1. Regulatory Status

• Approved by FDA (1996), EMA (1998)
• Off-label use prevalent given toxicity concerns
• Limited approvals for indications beyond CMV retinitis

2. Patent Landscape

• Original patent expired (~2014)
• No recent new patents filed; generics dominate current landscape
• Proprietary formulations or delivery methods remain potential strategic assets

3. Upcoming Regulatory Trends

• Increased oversight on drug toxicity and off-label use
• Potential for expanded approvals in resistant CMV infections or other DNA virus-related diseases

---

How Does VISTIDE Compare to Other Antiviral Therapies?

Attribute	VISTIDE	Ganciclovir/Valganciclovir	Foscarnet	Cidofovir (generic)
Administration	IV	Oral, IV	IV	IV
Indications	Refractory CMV retinitis	CMV retinitis	Resistant CMV	Refractory cases
Toxicity	Nephrotoxicity, myelosuppression	Hematologic, GI	Nephrotoxicity	Nephrotoxicity
Ease of Use	Complex	Easier (oral)	Moderate	Complex

In the current market, VISTIDE's niche remains in refractory cases or where other therapies fail.

---

What Are the Main Challenges and Opportunities?

Challenges	Opportunities
Toxicity profile limits broad use	Development of safer formulations or indications
Declining global incidence in high-income regions	Expansion in LMICs with accessible healthcare infrastructure
Patent expiration and generic competition	Strategic licensing, new delivery methods
Competition from emerging therapies	Potential in antiviral-resistant infections and novel viral targets

---

Conclusion: Projected Market and Financial Outlook

VISTIDE’s market is characterized by niche demand, primarily in refractory CMV infections and specific research indications. Its financial trajectory is likely to remain subdued in mature markets, with annual revenues below USD 10-15 million absent significant new indications or formulations. In LMICs, where access issues persist, VISTIDE could maintain a modest but stable demand. Strategic opportunities surrounding formulation innovations, expanded indications, or combination therapies could alter this outlook, but the drug faces ongoing challenges from toxicity and competition.

---

Key Takeaways

• Market Size & Demand: Currently limited, with annual sales below USD 10 million, driven mainly by niche indications and low-income markets.
• Regulatory & Patent Impact: Patent expiry and safety concerns limit growth opportunities; generics have eroded pricing power.
• Competitive Landscape: Dominated by ganciclovir/valganciclovir; VISTIDE remains an alternative for refractory cases.
• Future Potential: Focused on formulation innovation, expanded indications, and use in resistant infections; risks include toxicity and market competition.
• Strategic Focus: Opportunities exist in LMIC markets and research-driven repurposing, but broad market growth appears unlikely.

---

FAQs

1. Why has VISTIDE's market declined since its peak in the late 1990s?
The widespread adoption of effective ART has significantly reduced CMV retinitis incidence in high-income countries, coupled with the availability of more convenient oral therapies, leading to declining demand for VISTIDE.

2. Are there ongoing efforts to develop less toxic formulations of cidofovir?
Research is ongoing into intravitreal implants and nanoparticle delivery systems aimed at reducing systemic toxicity and expanding usability.

3. Could VISTIDE regain market share with new indications?
Potential exists if clinical trials demonstrate efficacy in other viral infections or resistant cases, but toxicity remains a major hurdle.

4. How does the toxicity profile influence VISTIDE's clinical use?
Nephrotoxicity and myelosuppression limit use to refractory cases or specialized settings; co-administration with probenecid and hydration complicates administration.

5. What is the outlook for VISTIDE in developing countries?
In LMICs with limited access to newer therapies, VISTIDE may continue to serve as a critical antiviral agent, potentially sustaining low-volume sales.

---

References

[1] Food and Drug Administration. VISTIDE (cidofovir) prescribing information. 1996.
[2] National Institute of Allergy and Infectious Diseases (NIAID). CMV retinitis statistics. 2020.
[3] IMS Health. Global Pharma Market Report. 2015.
[4] Patent status database, United States Patent and Trademark Office. 2014.
[5] World Health Organization. HIV/AIDS country profiles. 2022.