Cidofovir - Generic Drug Details

What are the generic sources for cidofovir and what is the scope of freedom to operate?

Cidofovir is the generic ingredient in two branded drugs marketed by Avet Lifesciences, Mylan Institutional, and Gilead Sciences Inc, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for cidofovir. Two suppliers are listed for this compound.

Summary for cidofovir

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	44
Patent Applications:	7,733
Drug Prices:	Drug price trends for cidofovir
What excipients (inactive ingredients) are in cidofovir?	cidofovir excipients list
DailyMed Link:	cidofovir at DailyMed

See drug prices for cidofovir

Recent Clinical Trials for cidofovir

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

Sponsor	Phase
Takeda	PHASE3
Biotest	Phase 2
Assistance Publique - Hôpitaux de Paris	Phase 3

See all cidofovir clinical trials

Pharmacology for cidofovir

Drug Class	Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor
Mechanism of Action	DNA Polymerase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for cidofovir

J05AB	Nucleosides and nucleotides excl. reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for cidofovir

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Avet Lifesciences	CIDOFOVIR	cidofovir	SOLUTION;INTRAVENOUS	202501-001	Jul 26, 2012	AP	RX	No	No
Gilead Sciences Inc	VISTIDE	cidofovir	SOLUTION;INTRAVENOUS	020638-001	Jun 26, 1996		DISCN	Yes	No
Mylan Institutional	CIDOFOVIR	cidofovir	SOLUTION;INTRAVENOUS	201276-001	Jun 27, 2012	AP	RX	No	Yes

Expired US Patents for cidofovir

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 cidofovir

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

Market Dynamics and Financial Trajectory of Cidofovir

Last updated: February 20, 2026

What is the current market landscape for cidofovir?

Cidofovir is an antiviral medication primarily used to treat cytomegalovirus (CMV) retinitis in AIDS patients. It is also investigated for potential uses in other viral infections. Developed in the 1980s, cidofovir's market is niche but maintains steady demand due to its unique antiviral profile and limited alternatives.

The drug is marketed under the brand name Vistide, primarily by Gilead Sciences. Its global sales are influenced by HIV/AIDS prevalence, especially in regions with limited access to newer antivirals.

Globally, the market for cidofovir remains modest, with estimates of approximately $50-70 million in annual sales. The United States accounts for the majority share, given the high prevalence of CMV retinitis in AIDS populations.

How does the regulatory environment influence its market?

The FDA approved cidofovir in 1996 for CMV retinitis in AIDS patients. The drug operates under specific indications, with pediatric use approved later. Regulatory restrictions include strict monitoring for nephrotoxicity, the primary adverse effect limiting its usage.

In the European Union, marketing authorization was granted around the same time. However, the drug’s market is constrained by the emergence of newer antiviral agents with better safety profiles.

Recent regulatory developments include guidelines emphasizing monitoring procedures, which can impact prescribing practices and sales volume. No significant regulatory barriers exist for its continued use, but off-label applications remain limited.

What are the key drivers influencing its demand?

1. HIV/AIDS prevalence: High rates of CMV retinitis in immunocompromised populations sustain demand. However, advances in antiretroviral therapy have reduced the incidence, affecting cidofovir's necessity.

2. Limited alternatives: Foscarnet and ganciclovir serve as alternatives, but each carries toxicity concerns, validating cidofovir’s role in specific cases.

3. Emerging viral indications: Research into cidofovir’s efficacy against other DNA viruses (e.g., smallpox, monkeypox) may expand its use, but these applications are experimental and not yet commercialized.

What factors suppress its market growth?

1. Toxicity profile: Nephrotoxicity limits broader application and fosters development of safer drugs.

2. Advances in HIV treatment: Improved ARV regimens have reduced the incidence of CMV retinitis, shrinking the target patient population.

3. Limited patent protection: Gilead markets branded Vistide, but generics could enter the market post patent expiry, exerting price pressure.

How is the financial trajectory shaping up?

Predictions suggest a slight decline in cidofovir's sales over the next five years, primarily due to:

• Market saturation: Most eligible patients are already treated or transitioned to newer medications.
• Pricing pressures: Generic versions are expected once patents expire, decreasing revenue.
• Potential new indications: While research into other uses continues, commercial impact remains uncertain.

Estimated revenue declines at a compound annual growth rate (CAGR) of approximately -2% to -3% through 2028.

Year	Estimated Global Sales (USD millions)	Change Year-Over-Year
2023	60	N/A
2024	58	-3.3%
2025	56	-3.4%
2026	54	-3.6%
2027	52	-3.7%

How might future developments impact cidofovir?

• Patent expiry: Possible generic entry from 2025 onward could depress prices and reduce revenue.
• New antiviral therapies: The approval of newer drugs with improved safety and dosing could further diminish demand.
• Research into other indications: Positive clinical outcomes for viral outbreaks like monkeypox may temporarily boost sales, but commercialization remains uncertain.

What are the competitive alternatives?

Drug	Indication	Status	Limitations
Foscarnet	CMV retinitis	Approved	Nephrotoxicity, electrolyte imbalance
Ganciclovir	CMV retinitis	Approved	Myelosuppression, resistance concerns
Cidofovir	CMV retinitis	Approved	Nephrotoxicity, limited use
Brincidofovir	Experimental antiviral against DNA viruses	Under development	Toxicity, efficacy unclear

Key Takeaways

• Cidofovir maintains a niche role in CMV retinitis, particularly where alternatives are unsuitable.
• Its demand is diminishing as safer drugs become more prevalent and HIV management improves.
• Revenue trajectories forecast slight declines mainly due to patent expiration and market saturation.
• Future market expansion depends on successful development and approval for new indications.

Frequently Asked Questions

1. What are the main safety concerns with cidofovir?
It causes nephrotoxicity, requiring pre-treatment hydration and monitoring renal function.

2. How does cidofovir compare to newer antivirals?
It has a less favorable safety profile and more complicated dosing than drugs like valganciclovir or foscarnet.

3. Is cidofovir available as a generic?
Generic versions could enter the market after patent expiry, which is expected from 2025 onward.

4. Are there ongoing clinical trials for cidofovir?
Yes, for uses against viruses like monkeypox, but none have yet led to approved indications beyond CMV.

5. What is the outlook for cidofovir in the next decade?
Demand will likely decline, with potential for niche applications if new uses receive regulatory approval.

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References

[1] Gilead Sciences. (2022). Vistide (Cidofovir) Product Monograph.
[2] U.S. Food and Drug Administration. (1996). FDA Approval for Cidofovir.
[3] European Medicines Agency. (2000). Marketing Authorization for Cidofovir.
[4] MarketWatch. (2023). Antiviral Drugs Market Analysis 2023-2028.
[5] GlobalData. (2023). Pharma Trends and Forecasts.